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1.  Effects of Tamoxifen and Raloxifene on Memory and Other Cognitive Abilities: Cognition in the Study of Tamoxifen and Raloxifene 
Journal of Clinical Oncology  2009;27(31):5144-5152.
To compare the effects of two selective estrogen receptor modulators, tamoxifen and raloxifene, on global and domain-specific cognitive function.
Patients and Methods
The National Surgical Adjuvant Breast and Bowel Project's Study of Tamoxifen and Raloxifene (STAR) study was a randomized clinical trial of tamoxifen 20 mg/d or raloxifene 60 mg/d in healthy postmenopausal women at increased risk of breast cancer. The 1,498 women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial, beginning 18 months after STAR enrollment started. A cognitive test battery modeled after the one used in the Women's Health Initiative Study of Cognitive Aging (WHISCA) was administered. Technicians were centrally trained to administer the battery and recertified every 6 months. Analyses were conducted on all participants and on 273 women who completed the first cognitive battery before they started taking their medications.
Overall, there were no significant differences in adjusted mean cognitive scores between the two treatment groups across visits. There were significant time effects across the three visits for some of the cognitive measures. Similar results were obtained for the subset of women with true baseline measures.
Tamoxifen and raloxifene are associated with similar patterns of cognitive function in postmenopausal women at increased risk of breast cancer. Future comparisons between these findings and patterns of cognitive function in hormone therapy and placebo groups in WHISCA should provide additional insights into the effects of tamoxifen and raloxifene on cognitive function in older women.
PMCID: PMC2773473  PMID: 19770382
2.  Postmenopausal Hormone Therapy and Cognitive Outcomes: the Women's Health Initiative Memory Study (WHIMS) 
This review discusses major findings from the Women's Health Initiative Memory Study (WHIMS). WHIMS reported hormone therapy (HT) - conjugated equine estrogen (CEE) with or without medroxyprogesterone acetate (MPA) - increased the risk for dementia (HR 1.76 [95% CI, 1.19-2.60]; P=0.005) and global cognitive decline, with a mean decrement relative to placebo of 0.21 points on the Modified Mini Mental State Examination (3MS) (P=0.006) in women age 65 and older.
A subset of WHIMS participants joined the ancillary WHI Study of Cognitive Aging (WHISCA) trials, in which domain-specific cognitive tests and mood were measured annually. Compared with placebo, CEE+MPA had a negative impact on verbal memory over time (p=0.01); and CEE-Alone was associated with lower spatial rotational ability (p=<.01) at the initial assessment, but the difference diminished over time.
The ancillary WHIMS-MRI study measured subclinical cerebrovascular disease to possibly explain the negative cognitive findings reported by WHIMS and the increased clinical stroke in older women reported by the WHI. WHIMS-MRI reported that while CEE+MPA and CEE-Alone were not associated with increased ischemic brain lesion volume relative to placebo; both CEE+MPA and CEE-Alone were associated with lower mean brain volumes in the hippocampus (p=0.05); frontal lobe (p=0.004);and total brain (p=0.07). HT-associated reductions in hippocampal volumes were greatest in women with baseline 3MS scores ≤ 90.
PMCID: PMC4547365  PMID: 19932751
hormone therapy; cognition; brain MRI; cerebrovascular disease
3.  The Cross-Sectional Relationship Between Body Mass Index, Waist-Hip Ratio and Cognitive Performance in Postmenopausal Women Enrolled in the Women's Health Initiative (WHI) 
To determine if body weight (BMI) is independently associated with cognitive function in postmenopausal women and the relationship between body fat distribution as estimated by waist-hip-ratio (WHR) and cognitive function.
Cross-sectional data analysis
Baseline data from the Women's Health Initiative (WHI) hormone trials.
8745 postmenopausal women aged 65–79 years, free of clinical evidence of dementia and completed baseline evaluation in the Women's Health Initiative (WHI) hormone trials.
Participants completed a Modified Mini-Mental State Examination (3MSE), health and lifestyle questionnaires, and standardized measurements of height, weight, body circumferences and blood pressure. Statistical analysis of associations between 3MSE scores, BMI and WHR after controlling for known confounders.
With the exception of smoking and exercise, vascular disease risk factors, including hypertension, waist measurement, heart disease and diabetes, were significantly associated with 3MSE score and were included as co-variables in subsequent analyses. BMI was inversely related to 3MSE scores, for every 1 unit increase in BMI, 3MSE decrease 0.988 (p=.0001) after adjusting for age, education and vascular disease risk factors. BMI had the most pronounced association with poorer cognitive functioning scores among women with smaller waist measurements. Among women with the highest WHR, cognitive scores increased with BMI.
Increasing BMI is associated with poorer cognitive function in women with smaller WHR. Higher WHR, estimating central fat mass, is associated with higher cognitive function in this cross-sectional study. Further research is needed to clarify the mechanism for this association.
PMCID: PMC2955186  PMID: 20646100
obesity; cognition; dementia; waist-hip ratio; women
4.  Behaviorally Supported Exercise Predicts Weight Loss in Obese Adults Through Improvements in Mood, Self-Efficacy, and Self-Regulation, Rather Than by Caloric Expenditure 
The Permanente Journal  2011;15(1):23-27.
Background: The relationship of exercise to weight loss, beyond minimal caloric expenditures possible in obese and deconditioned individuals, requires clarification.
Objective: We assessed whether changes in theory-based psychological variables associated with participation in an exercise treatment extended to psychologically based predictors of controlled eating and weight and waist-circumference reductions.
Methods: A group of 137 adults with severe obesity (mean body mass index, 42.2 kg/m2) volunteered for an exercise-support and nutrition-education treatment of 26 weeks' duration that was based on social cognitive theory. Exercise- and eating-related measures of mood, self-regulation, and self-efficacy were obtained at baseline and at treatment end, along with weight, waist circumference, and exercise volume. Analyses were also conducted separately for women participants only (n = 102).
Results: Treatment-induced changes in total mood disturbance, self-regulatory skill usage for exercise, and exercise self-efficacy were significantly related to changes in self-efficacy to control emotional eating, self-regulatory skill usage for controlled eating, and overall self-efficacy for controlled eating, respectively (p < 0.001). Changes in the eating-related measures significantly predicted changes in weight and waist circumference with adjusted R2 values from 0.15 to 0.21 and 0.28 to 0.30, respectively (p < 0.001). Post-hoc testing indicated a strong negative correlation between exercise completed and weight change (r = −0.62); however, only 12.4% of the observed weight change was accounted for through associated caloric expenditures.
Conclusion: Exercise may support weight loss primarily through psychological rather than physiological pathways. Although the models tested were viable, additional modifiable variables may further strengthen the prediction of weight and waist-circumference change and benefit weight-loss theory and treatment outcomes.
PMCID: PMC3048629  PMID: 21505614
5.  Hormone therapy, dementia, and cognition: the Women's Health Initiative ten years on 
Principle findings on dementia from the Women's Health Initiative Memory Study (WHIMS) showed that conjugated equine estrogens plus medroxyprogesterone acetate (CEE/MPA) increase dementia risk in women aged 65 years and above, but not risk of mild cognitive impairment. The dementia finding was unexpected, given consistent observational evidence that associates estrogen-containing hormone therapy use with reduced risk of Alzheimer's disease. It remains controversial whether hormone use by younger postmenopausal women near the time of menopause reduces dementia risk or whether WHIMS findings should be generalized to younger women. Given the challenges of conducting a primary prevention trial to address that question, it is helpful to consider the impact of hormone therapy on cognitive test performance, particularly verbal memory, for its own sake and as a proxy for dementia risk. The WHI Study of Cognitive Aging (WHISCA) showed that CEE/MPA worsened verbal memory, whereas CEE alone had no influence on cognition. These findings have been replicated in several randomized clinical trials. The apparent negative effect of CEE/MPA on verbal memory does not appear to be age-dependent. Additional investigations are needed to understand the impact of other hormonally active compounds on dementia and cognitive outcomes.
PMCID: PMC3667708  PMID: 22612612
Alzheimer's disease; cognition; dementia; estrogen; hormone therapy; menopause; memory; progestogen; review; selective estrogen receptor modulator; women's health initiative
6.  The Association of Serum Total Peptide YY (PYY) with Obesity and Body Fat Measures in the CODING Study 
PLoS ONE  2014;9(4):e95235.
PYY is an appetite suppressing hormone. Low circulating PYY has been linked to greater BMI. However data is controversial and this association has not been verified in large human populations.
The purpose of this study was to investigate if fasting serum total PYY is associated with obesity status and/or adiposity at the population level.
A total of 2094 subjects (Male-523, Female-1571) participated in this investigation. Total PYY was measured in fasting serum by enzyme-linked immunosorbent assay. Obesity status (NW-normal-weight, OW-overweight and OB-obese) was determined by the Bray Criteria according to body fat percentage measured by dual-energy x-ray absorptiometry and the WHO criteria according to BMI. One-way ANOVA and multiple regression was used to assess the adiposity-specific association between PYY and the following; weight, BMI, waist-circumference, hip-circumference, waist-hip ratio, percent body fat (%BF), trunk fat (%TF), android fat (%AF) and gynoid fat (%GF).
PYY was not significantly different among NW, OW and OB groups defined by neither %BF nor BMI for both men and women. However among women, fasting PYY was positively associated with adiposity measures. Women with the highest (Top 33%) waist-circumference, %BF and %TF had significantly higher PYY (10.5%, 8.3% and 9.2% respectively) than women with the lowest (Bottom 33%). Age, smoking, medication use and menopause were all positively associated with PYY levels in women but not in men.
To our knowledge this is the largest population based study, with the most comprehensive analysis and measures of confounding factors, to explore the relationship of circulating PYY with obesity. Contrary to initial findings in the literature we discovered that PYY was positively associated with body fat measures (waist-circumference, %BF and %TF) in women. Although the effect size of the positive association of PYY with obesity in women is small, and potentially negligible, it may in fact represent a protective response against significant weight gain.
PMCID: PMC3990607  PMID: 24743402
7.  Long-Term Risk of Incident Type 2 Diabetes and Measures of Overall and Regional Obesity: The EPIC-InterAct Case-Cohort Study 
PLoS Medicine  2012;9(6):e1001230.
A collaborative re-analysis of data from the InterAct case-control study conducted by Claudia Langenberg and colleagues has established that waist circumference is associated with risk of type 2 diabetes, independently of body mass index.
Waist circumference (WC) is a simple and reliable measure of fat distribution that may add to the prediction of type 2 diabetes (T2D), but previous studies have been too small to reliably quantify the relative and absolute risk of future diabetes by WC at different levels of body mass index (BMI).
Methods and Findings
The prospective InterAct case-cohort study was conducted in 26 centres in eight European countries and consists of 12,403 incident T2D cases and a stratified subcohort of 16,154 individuals from a total cohort of 340,234 participants with 3.99 million person-years of follow-up. We used Prentice-weighted Cox regression and random effects meta-analysis methods to estimate hazard ratios for T2D. Kaplan-Meier estimates of the cumulative incidence of T2D were calculated. BMI and WC were each independently associated with T2D, with WC being a stronger risk factor in women than in men. Risk increased across groups defined by BMI and WC; compared to low normal weight individuals (BMI 18.5–22.4 kg/m2) with a low WC (<94/80 cm in men/women), the hazard ratio of T2D was 22.0 (95% confidence interval 14.3; 33.8) in men and 31.8 (25.2; 40.2) in women with grade 2 obesity (BMI≥35 kg/m2) and a high WC (>102/88 cm). Among the large group of overweight individuals, WC measurement was highly informative and facilitated the identification of a subgroup of overweight people with high WC whose 10-y T2D cumulative incidence (men, 70 per 1,000 person-years; women, 44 per 1,000 person-years) was comparable to that of the obese group (50–103 per 1,000 person-years in men and 28–74 per 1,000 person-years in women).
WC is independently and strongly associated with T2D, particularly in women, and should be more widely measured for risk stratification. If targeted measurement is necessary for reasons of resource scarcity, measuring WC in overweight individuals may be an effective strategy, since it identifies a high-risk subgroup of individuals who could benefit from individualised preventive action.
Please see later in the article for the Editors' Summary
Editors' Summary
Worldwide, more than 350 million people have diabetes, and this number is increasing rapidly. Diabetes is characterized by dangerous levels of glucose (sugar) in the blood. Blood sugar levels are usually controlled by insulin, a hormone that the pancreas releases after meals (digestion of food produces glucose). In people with type 2 diabetes (the commonest form of diabetes), blood sugar control fails because the fat and muscle cells that normally respond to insulin by removing sugar from the blood become insulin resistant. Type 2 diabetes can be controlled with diet and exercise, and with drugs that help the pancreas make more insulin or that make cells more sensitive to insulin. The long-term complications of diabetes, which include an increased risk of heart disease and stroke, reduce the life expectancy of people with diabetes by about 10 years compared to people without diabetes.
Why Was This Study Done?
A high body mass index (BMI, a measure of body fat calculated by dividing a person's weight in kilograms by their height in meters squared) is a strong predictor of type 2 diabetes. Although the risk of diabetes is greatest in obese people (who have a BMI of greater than 30 kg/m2), many of the people who develop diabetes are overweight—they have a BMI of 25–30 kg/m2. Healthy eating and exercise reduce the incidence of diabetes in high-risk individuals, but it is difficult and expensive to provide all overweight and obese people with individual lifestyle advice. Ideally, a way is needed to distinguish between people with high and low risk of developing diabetes at different levels of BMI. Waist circumference is a measure of fat distribution that has the potential to quantify diabetes risk among people with different BMIs because it estimates the amount of fat around the abdominal organs, which also predicts diabetes development. In this case-cohort study, the researchers use data from the InterAct study (which is investigating how genetics and lifestyle interact to affect diabetes risk) to estimate the long-term risk of type 2 diabetes associated with BMI and waist circumference. A case-cohort study measures exposure to potential risk factors in a group (cohort) of people and compares the occurrence of these risk factors in people who later develop the disease and in a randomly chosen subcohort.
What Did the Researchers Do and Find?
The researchers estimated the association of BMI and waist circumference with type 2 diabetes from baseline measurements of the weight, height, and waist circumference of 12,403 people who subsequently developed type 2 diabetes and a subcohort of 16,154 participants enrolled in the European Prospective Investigation into Cancer and Nutrition (EPIC). Both risk factors were independently associated with type 2 diabetes risk, but waist circumference was a stronger risk factor in women than in men. Obese men (BMI greater than 35 kg/m2) with a high waist circumference (greater than 102 cm) were 22 times more likely to develop diabetes than men with a low normal weight (BMI 18.5–22.4 kg/m2) and a low waist circumference (less than 94 cm); obese women with a waist circumference of more than 88 cm were 31.8 times more likely to develop type 2 diabetes than women with a low normal weight and waist circumference (less than 80 cm). Importantly, among overweight people, waist circumference measurements identified a subgroup of overweight people (those with a high waist circumference) whose 10-year cumulative incidence of type 2 diabetes was similar to that of obese people.
What Do These Findings Mean?
These findings indicate that, among people of European descent, waist circumference is independently and strongly associated with type 2 diabetes, particularly among women. Additional studies are needed to confirm this association in other ethnic groups. Targeted measurement of waist circumference in overweight individuals (who now account for a third of the US and UK adult population) could be an effective strategy for the prevention of diabetes because it would allow the identification of a high-risk subgroup of people who might benefit from individualized lifestyle advice.
Additional Information
Please access these web sites via the online version of this summary at
The US National Diabetes Information Clearinghouse provides information about diabetes for patients, health care professionals, and the general public, including detailed information on diabetes prevention (in English and Spanish)
The US Centers for Disease Control and Prevention provides information on all aspects of overweight and obesity (including some information in Spanish)
The UK National Health Service Choices website provides information for patients and carers about type 2 diabetes, about the prevention of type 2 diabetes, and about obesity; it also includes peoples stories about diabetes and about obesity
The charity Diabetes UK also provides detailed information for patients and carers, including information on healthy lifestyles for people with diabetes, and has a further selection of stories from people with diabetes; the charity Healthtalkonline has interviews with people about their experiences of diabetes
More information on the InterAct study is available
MedlinePlus provides links to further resources and advice about diabetes and diabetes prevention and about obesity (in English and Spanish)
PMCID: PMC3367997  PMID: 22679397
8.  Preventing Weight Gain in Women in Rural Communities: A Cluster Randomised Controlled Trial 
PLoS Medicine  2016;13(1):e1001941.
Obesity is reaching epidemic proportions in both developed and developing countries. Even modest weight gain increases the risk for chronic illness, yet evidence-based interventions to prevent weight gain are rare. This trial will determine if a simple low-intensity intervention can prevent weight gain in women compared to general health information.
Methods and Findings
We conducted a 1-yr pragmatic, cluster randomised controlled trial in 41 Australian towns (clusters) randomised using a computer-generated randomisation list for intervention (n = 21) or control (n = 20). Women aged 18 to 50 yr were recruited from the general population to receive a 1-yr self-management lifestyle intervention (HeLP-her) consisting of one group session, monthly SMS text messages, one phone coaching session, and a program manual, or to a control group receiving one general women’s health education session. From October 2012 to April 2014 we studied 649 women, mean age 39.6 yr (+/− SD 6.7) and BMI of 28.8 kg/m2 (+/− SD 6.9) with the primary outcome weight change between groups at 1 yr. The mean change in the control was +0.44 kg (95% CI −0.09 to 0.97) and in the intervention group −0.48kg (95% CI −0.99 to 0.03) with an unadjusted between group difference of −0.92 kg (95% CI −1.67 to −0.16) or −0.87 kg (95% CI −1.62 to −0.13) adjusted for baseline values and clustering. Secondary outcomes included improved diet quality and greater self-management behaviours. The intervention appeared to be equally efficacious across all age, BMI, income, and education subgroups. Loss to follow-up included 23.8% in the intervention group and 21.8% in the control group and was within the anticipated range. Limitations include lack of sensitive tools to measure the small changes to energy intake and physical activity. Those who gained weight may have been less inclined to return for 1 yr weight measures.
A low intensity lifestyle program can prevent the persistent weight gain observed in women. Key features included community integration, nonprescriptive simple health messages, small changes to behaviour, low participant burden, self-weighing, and delivery including a mix of group, phone, and SMS text reminders. The findings support population strategies to halt the rise in obesity prevalence.
In a pragmatic, cluster-randomised controlled trial, Catherine Lombard and colleagues assess the value of a self-management lifestyle intervention to prevent weight gain among women living in rural Australia.
Editors' Summary
Obesity—having an unhealthy amount of body fat—is a global public health problem. In the US, for example, more than one-third of adults are obese and another third are overweight. Obesity is defined as having a body mass index (BMI; an indicator of body fat calculated by dividing a person’s weight in kilograms by their height in meters squared) of equal to or more than 30 kg/m2; overweight individuals have a BMI of 25.0–29.9 kg/m2. Increased body fat is associated with an increased risk of developing diabetes, cancer, cardiovascular disease and other chronic diseases.. People gain body fat by consuming food and drink that contains more energy (calories) than they need for their daily activities. So excess body fat can be prevented and reversed by eating a diet that contains fewer calories and by being more active.
Why Was This Study Done?
BMI increases with age in most adults although in recent years young adults have been shown to be gaining body fat faster than older adults. However, the adult weight gain per year is generally less than 1 kg and could be prevented by encouraging people to eat just a little less and exercise just a little more. Prevention of weight gain is likely to be easier than reversal of established obesity, but few interventions designed to prevent weight gain have been rigorously tested. In this pragmatic randomized controlled trial, the researchers investigate whether a simple low-intensity intervention can prevent weight gain among 18–50-year-old women living in rural communities in Australia. Rates of obesity are generally higher among women than men and, in affluent countries, rural-dwelling women have higher rates of weight gain and obesity than urban-dwelling women—in Australia, young women living in rural and metropolitan areas gain an average of 700 g and 550 g per year, respectively. A pragmatic cluster randomized controlled trial randomly assigns groups of people (here, women living in different towns) to receive alternative interventions and compares outcomes in the differently treated “clusters” under real-life conditions.
What Did the Researchers Do and Find?
The researchers assigned 41 Australian towns to receive a 1 yr self-management lifestyle intervention (HeLP-her) or to act as controls. The intervention consisted of one group session during which facilitators delivered general health information and five simple health messages (for example, try to eat two servings of fruit and five servings of vegetables a day), a program manual to help participants develop a personalized weight gain prevention strategy, monthly text message to remind participants of key behaviors for weight gain prevention, and a 20-min personal phone coaching session delivered three months into the trial. Participants in the control clusters received a group education session on general women’s health topics at the start of the trial. In total, 649 women with an average baseline BMI of 28.2kg/m2 participated in the trial. After one year, the average weight change was +0.44 kg in the control arm of the trial and −0.48 kg in the intervention arm (a between group difference in weight change of −0.92 kg). The intervention also improved diet quality and self-management behavior and was equally efficacious across all age, BMI, income, and education subgroups.
What Do These Findings Mean?
These findings suggest that a low-intensity lifestyle program can prevent persistent weight gain among women. Specifically, the year-long HeLP-her intervention prevented a weight gain of nearly 1 kg on average among women living in rural Australia. Notably, a recent modeling study estimated that a 1 kg weight loss, if applied across the US population, could avoid 2 million cases of diabetes, 1.5 million cases of cardiovascular disease, and more than 73,000 cases of cancer. Although it is difficult to identify the successful elements of any intervention that targets multiple behaviors, key components of the HeLP-her intervention probably include the use of simple, non-prescriptive health messages, the focus on small behavioral changes, regular self-weighing, and the use of both personal and electronic means to deliver the intervention. Some aspects of this trial (for example, nearly a quarter of the participants did not complete the trial) may affect the accuracy of its findings and a longer follow-up is needed to determine the long-term effects of the intervention. Nevertheless, these findings provide new information on effective weight gain prevention strategies that align with current clinical guidelines and population strategies designed to halt the global rise in obesity.
Additional Information
This list of resources contains links that can be accessed when viewing the PDF on a device or via the online version of the article at
The World Health Organization provides information on obesity (in several languages)
The Global Burden of Disease website provides the latest details about global obesity trends; the International Obesity Taskforce also provides information about the global obesity epidemic
The UK National Health Service Choices website provides information about obesity (including some real stories), healthy eating, exercising
The US Centers for Disease Control and Prevention has information on all aspects of overweight and obesity is a resource provided by the US Department of Agriculture that provides individuals and health care professionals with user-friendly information on nutritional and physical exercise
The US National Institute of Diabetes and Digestive and Kidney Diseases provides information on weight control and healthy living
MedlinePlus provides links to other sources of information on obesity (in English and Spanish)
More information about obesity in Australia, this trial, and the HeLP-her intervention is available
PMCID: PMC4718637  PMID: 26785406
9.  Mothers after Gestational Diabetes in Australia (MAGDA): A Randomised Controlled Trial of a Postnatal Diabetes Prevention Program 
PLoS Medicine  2016;13(7):e1002092.
Gestational diabetes mellitus (GDM) is an increasingly prevalent risk factor for type 2 diabetes. We evaluated the effectiveness of a group-based lifestyle modification program in mothers with prior GDM within their first postnatal year.
Methods and Findings
In this study, 573 women were randomised to either the intervention (n = 284) or usual care (n = 289). At baseline, 10% had impaired glucose tolerance and 2% impaired fasting glucose. The diabetes prevention intervention comprised one individual session, five group sessions, and two telephone sessions. Primary outcomes were changes in diabetes risk factors (weight, waist circumference, and fasting blood glucose), and secondary outcomes included achievement of lifestyle modification goals and changes in depression score and cardiovascular disease risk factors. The mean changes (intention-to-treat [ITT] analysis) over 12 mo were as follows: −0.23 kg body weight in intervention group (95% CI −0.89, 0.43) compared with +0.72 kg in usual care group (95% CI 0.09, 1.35) (change difference −0.95 kg, 95% CI −1.87, −0.04; group by treatment interaction p = 0.04); −2.24 cm waist measurement in intervention group (95% CI −3.01, −1.42) compared with −1.74 cm in usual care group (95% CI −2.52, −0.96) (change difference −0.50 cm, 95% CI −1.63, 0.63; group by treatment interaction p = 0.389); and +0.18 mmol/l fasting blood glucose in intervention group (95% CI 0.11, 0.24) compared with +0.22 mmol/l in usual care group (95% CI 0.16, 0.29) (change difference −0.05 mmol/l, 95% CI −0.14, 0.05; group by treatment interaction p = 0.331). Only 10% of women attended all sessions, 53% attended one individual and at least one group session, and 34% attended no sessions. Loss to follow-up was 27% and 21% for the intervention and control groups, respectively, primarily due to subsequent pregnancies. Study limitations include low exposure to the full intervention and glucose metabolism profiles being near normal at baseline.
Although a 1-kg weight difference has the potential to be significant for reducing diabetes risk, the level of engagement during the first postnatal year was low. Further research is needed to improve engagement, including participant involvement in study design; it is potentially more effective to implement annual diabetes screening until women develop prediabetes before offering an intervention.
Trial Registration
Australian New Zealand Clinical Trials Registry ACTRN12610000338066
Sharleen O'Reilly and colleagues investigate the effectiveness of a diabetes prevention program for reducing weight, waist circumference and fasting glucose measurements for women who have had gestational diabetes.
Author Summary
Why Was This Study Done?
Women who have had gestational diabetes are much more likely to develop type 2 diabetes.
Although many diabetes prevention programs for people over the age of 50 exist, few are tailored to the needs of young mothers who have had gestational diabetes.
On the assumption that offering prevention earlier is beneficial, researchers developed and tested a diabetes prevention program for women who had gestational diabetes; women participated in the program during their first year after giving birth.
What Did the Researchers Do and Find?
The researchers enrolled 573 women in a one-year study: 284 women were assigned to the diabetes prevention program (one individual session and five group sessions over a three-month period, followed by telephone calls at six and nine months), and 289 were assigned to the control group (usual postnatal care).
After one year, the average changes for women in the diabetes prevention program were a 0.23-kg decrease in weight, a 2.24-cm decrease in waist circumference, and a 0.18-mmol/l increase in fasting blood glucose, while the average changes for women in the control group were a 0.72-kg increase in weight, a 1.74-cm decrease in waist circumference, and a 0.22-mmol/l increase in fasting blood glucose. The between-group difference in weight change was 0.95 kg.
The number of women who attended the diabetes prevention program was lower than anticipated—10% attended all sessions, and 53% attended the individual session plus at least one group session; about a quarter of women did not complete the study, mainly due to becoming pregnant again.
What Do These Findings Mean?
These findings suggest that although a diabetes prevention program designed for women who have had gestational diabetes can prevent weight gain over 12 months, getting women to engage with the program was challenging, so it would not be sustainable in routine health services.
The women who participated in the study had low diabetes risk profiles (only one in ten had impaired glucose tolerance), and most diabetes prevention guidelines would not categorise them as being at sufficiently high risk for participation in a diabetes prevention program.
For diabetes prevention programs in women who have had gestational diabetes, further research is required on the process of engagement and lifestyle interventions at other time points, including participant involvement in the design of interventions. Australian clinical guidelines stipulate that women who have had gestational diabetes should be screened annually for diabetes. One option for management would be to wait until they develop prediabetes before offering a diabetes prevention program, which may prove more effective because their children will be older and women may be easier to engage in improving their health.
PMCID: PMC4961439  PMID: 27459502
10.  The relationships between body composition characteristics and cognitive functioning in a population-based sample of older British men 
BMC Geriatrics  2015;15:172.
Current research has established obesity as one of the main modifiable risk factors for cognitive impairment. However, evidence on the relationships of total and regional body composition measures as well as sarcopenia with cognitive functioning in the older population remains inconsistent.
Data are based on 1,570 participants from the British Regional Heart Study (BRHS), a cohort of older British men from 24 British towns initiated in 1978–80, who were re-examined in 2010–12, aged 71–92 years. Cognitive functioning was assessed with the Test-Your-Memory cognitive screening tool. Body composition characteristics assessed using bioelectrical impedance analysis included total fat mass (FM), central FM, peripheral FM, and visceral fat level. Sarcopenia was defined using the European Working Group on Sarcopenia in Older People (EWGSOP) definition of severe sarcopenia and the Foundation for the National Institutes of Health (FNIH) sarcopenia project criteria.
Among 1,570 men, 636 (41 %) were classified in the mild cognitive impairment (MCI) and 133 (8 %) in the severe cognitive impairment (SCI) groups. Age-adjusted multinomial logistic regressions showed that compared with participants in the normal cognitive ageing group, those with SCI were more likely to have waist circumference >102 cm, BMI >30 kg/m2, to be in the upper quintile of total FM, central FM, peripheral FM and visceral fat level and to be sarcopenic. The relationships remained significant for total FM (RR = 2.16, 95 % CI 1.29–3.63), central FM (RR = 1.85, 95 % CI 1.09–3.14), peripheral FM (RR = 2.67, 95 % CI 1.59–4.48), visceral fat level (RR = 2.28, 95 % CI 1.32–3.94), BMI (RR = 2.25, 95 % CI 1.36–3.72) and waist circumference (RR = 1.63, 95 % CI 1.05–2.55) after adjustments for alcohol, smoking, social class, physical activity and history of cardiovascular diseases or diabetes. After further adjustments for interleukin-6 and insulin resistance, central FM, waist circumference and sarcopenia were no longer significantly associated with SCI.
Increased levels of peripheral FM, visceral fat level, and BMI are associated with SCI among older people. Distinct pathophysiological mechanisms link regional adipose tissue deposition and cognitive functioning.
PMCID: PMC4687114  PMID: 26692280
Obesity; Adiposity; Sarcopenia; Cognition; Dementia; Ageing
11.  National Economic Development Status May Affect the Association between Central Adiposity and Cognition in Older Adults 
PLoS ONE  2016;11(2):e0148406.
Obesity is becoming a global problem, rather than one found only in developed countries. Although recent studies have suggested a detrimental effect of obesity on cognition, studies of the relationship between obesity and cognition among older adults have been limited to developed countries. We aimed to examine the associations between central obesity, as measured by waist circumference, and cognition level in adults aged 50 years and older in England and Indonesia.
We used linear regression models to analyse these associations and multiple imputation to manage missing data. The 2006 English Longitudinal Study of Ageing Wave 3 is the source of data from England, while data from Indonesia is sourced from the 2007 Indonesian Family Life Survey Wave 4.
Centrally obese respondents had lower cognition levels than non-centrally obese respondents in England. In contrast, central adiposity had a statistically significant positive association with cognition in Indonesia. Higher levels of education and higher economic status were associated with higher cognitive ability, while age was associated with lower cognition in both countries. Elevated C-reactive protein (CRP) concentrations and smoking behaviour, both linked to higher risk of obesity, were negatively associated with cognitive ability among older adults in England, but they had no statistically significant association with cognition among Indonesians.
The contradictory findings on obesity and cognition in England and Indonesia not only create a puzzle, but they may also have different policy implications in these countries. Reducing the prevalence of obesity may be the main focus in England and other developed countries to maintain older adults’ cognition. However, Indonesia and other developing countries should place more emphasis on education, in addition to continued efforts to tackle the double burden of malnutrition, in order to prevent cognitive impairment among older adults.
PMCID: PMC4749166  PMID: 26863443
12.  Body size and time-to-pregnancy in black women 
Human Reproduction (Oxford, England)  2013;28(10):2856-2864.
Are overall and central obesity associated with reduced fecundability in US black women?
Overall and central obesity—based on self-reported measures of body mass index (BMI, kg/m2), waist circumference and waist-to-hip ratio—were independent risk factors for subfertility in our cohort.
Overall obesity (BMI ≥30 kg/m2) has been associated with infertility in several studies. The role of central obesity is less clear. There are no previous studies of time-to-pregnancy (TTP) in black women.
Data were derived from the Black Women's Health Study, a prospective cohort study. During 1995–2011, there were 2239 planned pregnancy attempts reported by 1697 women, resulting in 2022 births. Cohort retention was greater than 80%.
Eligible women were aged 21–40 years and reported at least one planned pregnancy attempt during 1995–2011. Height and weight were reported in 1995, with weight updated every two years; waist and hip circumferences were reported in 1995 and updated in 2003. A validation study within the cohort showed high correlations between self-reported and technician-measured weight (r = 0.97), height (r = 0.93), waist circumference (r = 0.75) and hip circumference (r = 0.74). In 2011, TTP was reported in months. Proportional probabilities regression models were used to estimate fecundability ratios (FRs) and 95% confidence intervals (CI), adjusting for covariates.
High BMI was associated with delayed conception: relative to BMI 18.5–24.9, FRs for BMI categories of <18.5, 25.0–29.9, 30.0–34.9 and ≥35.0 were 0.92 (CI: 0.64–1.32), 0.93 (CI: 0.84–1.03), 0.92 (CI: 0.79–1.06) and 0.73 (CI: 0.61–0.87), respectively. Associations were stronger among nulliparous women (P-interaction = 0.003). After controlling for BMI, reduced fecundability was observed among women with large waist circumferences (≥33 versus <26 inches: FR = 0.73, CI: 0.60–0.88) and large waist-to-hip ratios (≥0.85 versus <0.71: FR = 0.83, CI: 0.71–0.97).
TTP was reported retrospectively and error in recall is likely, particularly as time since the pregnancy increases. However, results were similar when based on the most recent versus first pregnancies. Confounding may have been introduced by the lack of control for important determinants of TTP. Nevertheless, control for maternal age and education, which are highly correlated with TTP determinants such as paternal age and persistence in trying, should reduce the extent of confounding. The analysis was confined to planned pregnancies. If pregnancy intention was related both to body size and fecundability, our results could be biased. Bias is likely to be small because we found little difference in body size and other measured characteristics between pregnancy planners and non-planners.
Our findings add to the growing body of literature showing that excess BMI is associated with reduced fecundability and further suggest that central obesity is an important independent risk factor for infertility. The relation of obesity to infertility is especially relevant to US black women because they have higher rates of obesity and infertility. Reductions in overall and central obesity may offer the potential to improve fertility outcomes.
This work was funded by National Cancer Institute grant CA58420. We have no competing interests to report.
PMCID: PMC3777573  PMID: 23958939
fertility; obesity; body mass index; cohort study; African Americans
13.  Supported Exercise Improves Controlled Eating and Weight through Its Effects on Psychosocial Factors: Extending a Systematic Research Program Toward Treatment Development 
The Permanente Journal  2012;16(1):7-18.
Background: Behavioral weight-loss treatments have been overwhelmingly unsuccessful. Many inadequately address both behavioral theory and extant research—especially in regard to the lack of viability of simply educating individuals on improved eating and exercise behaviors.
Objective: The aim was to synthesize research on associations of changes in exercise behaviors, psychosocial factors, eating behaviors, and weight; and then conduct further direct testing to inform the development of an improved treatment approach.
Methods: A systematic program of health behavior-change research based on social cognitive theory, and extensions of that theory applied to exercise and weight loss, was first reviewed. Then, to extend this research toward treatment development and application, a field-based study of obese adults was conducted. Treatments incorporated a consistent component of cognitive-behaviorally supported exercise during 26 weeks that was paired with either standard nutrition education (n = 183) or cognitive-behavioral methods for controlled eating that emphasized self-regulatory methods such as goal setting and caloric tracking, cognitive restructuring, and eating cue awareness (n = 247).
Results: Both treatment conditions were associated with improved self-efficacy, self-regulation, mood, exercise, fruit and vegetable consumption, weight, and waist circumference; with improvements in self-regulation for eating, fruit and vegetable consumption, weight, and waist circumference significantly greater in the cognitive-behavioral nutrition condition. Changes in exercise- and eating-related self-efficacy and self-regulation were associated with changes in exercise and eating (R2 = 0.40 and 0.17, respectively), with mood change increasing the explanatory power to R2 = 0.43 and 0.20. Improved self-efficacy and self-regulation for exercise carried over to self-efficacy and self-regulation for controlled eating (β= 0.53 and 0.68, respectively).
Conclusions: Development and longitudinal testing of a new and different approach to behavioral treatment for sustained weight loss that emphasizes exercise program-induced psychosocial changes preceding the facilitation of improved eating and weight loss should be guided by our present research.
PMCID: PMC3327117  PMID: 22529754
14.  Calcium and Vitamin D Supplementation and Cognitive Impairment in the Women’s Health Initiative 
Calcium and vitamin D are thought to play important roles in neuronal functioning. Studies have found associations between low serum vitamin D levels and reduced cognitive functioning, as well as high serum calcium levels and reduced cognitive functioning.
To examine the effects of vitamin D and calcium on cognitive outcomes in elderly women.
Post-hoc analysis of a randomized double-blinded placebo-controlled trial.
40 Women’s Health Initiative clinical centers across the U.S.
4143 women aged 65 years and older without probable dementia at baseline who participated in the WHI Calcium and Vitamin D trial and the Women’s Health Initiative Memory Study.
2034 women were randomized to 1000 mg of calcium carbonate combined with 400 IU of vitamin D3; 2109 women were randomized to placebo.
Primary: classifications of probable dementia or mild cognitive impairment via a 4-phase protocol that included central adjudication. Secondary: global cognitive function and individual cognitive subtests.
Mean age of participants was 71 years. During mean follow-up of 7.8 years, there were 39 cases of incident dementia among calcium plus vitamin D subjects compared to 37 cases among placebo subjects (hazard ratio=1.11, 95% CI: 0.71–1.74, p=0.64). Likewise, there were 98 cases of incident mild cognitive impairment among calcium plus vitamin D subjects compared to 108 cases among placebo subjects (hazard ratio=0.95, 95% CI: 0.72–1.25, p=0.72). There were no significant differences in incident dementia or mild cognitive impairment, or in global or domain-specific cognitive function between groups.
There was no association between treatment assignment and incident cognitive impairment. Further studies are needed to investigate the effects of vitamin D and calcium separately, on men and in other age and ethnic groups, and with other doses.
PMCID: PMC3521077  PMID: 23176129
Vitamin D; Calcium; Dementia; Cognition; Mild Cognitive Impairment
15.  Eating Behaviors, Mental Health, and Food Intake are Associated with Obesity in Older Congregate Meal Participants 
The relationship between eating behaviors, food intake, and mental health and the occurrence of obesity in older adults has rarely been investigated. Therefore, the objective of this study was to establish the associative links of these factors with two measures of obesity: class I obesity as indicated by body mass index (OB-BMI; BMI ≥ 30kg/m2) and class I obesity as indicated by waist circumference (OB-WC; WC ≥ 43 inches for men and ≥ 42 inches for women). Older adults participating in the Older American’s Act (OAA) congregate meal program (N = 113, mean age = 74 years, 74% female, 45% African American) were assessed. Eating behaviors (cognitive restraint, uncontrolled eating, and emotional eating), food groups group choices (sweets, salty snacks, and fruits), and mental health indices (depression, anxiety, and stress) were recorded by questionnaire and related to measured occurrence of OB-BMI and OB-WC. In a series of multivariate logistical regression models, we found cognitive restraint to be consistently and robustly associated with both measures of obesity. In the fully adjusted model, cognitive restraint, consumption of sweets, anxiety, and lack of depression were associated with OB-WC. In summary, we found an association of obesity with abnormal eating behaviors, certain food group intakes, and mental health symptoms in this population. These findings may guide the development of future weight management interventions in a congregate meal setting.
PMCID: PMC4332628  PMID: 25424510
16.  Excess gains in weight and waist circumference associated with childbearing: The Coronary Artery Risk Development in Young Adults Study (CARDIA) 
To examine the association of childbearing with weight and waist circumference (WC) changes, we compared women with and without pregnancies or births during follow-up.
A multicenter, longitudinal observational study over 10 years. Comparison groups defined by the number of pregnancies and births during follow-up: P0 (0 pregnancies; nongravid), P1 (1+ miscarriages or abortions; ‘short’ pregnancies), B1 (1 birth), and B2 (2+ births). Mean changes in weight and WC for P1, B1 and B2 groups vs P0 were examined separately by race (black and white), baseline parity (nulliparous and parous) and baseline weight status (normal weight; BMI <25 kg/m2 and overweight; BMI ≥25 kg/m2).
A population-based sample of 2070 women aged 18–30 y at baseline (1053 black subjects and 1017 white subjects) from Birmingham, Alabama, Chicago, Illinois, Minneapolis, Minnesota, and Oakland, California were examined five times between 1985–1986 and 1995–1996.
Weight and WC measurements were obtained using standardized protocol at baseline and examinations at years 2, 5, 7 and 10. Sociodemographic, reproductive, and behavioral attributes were assessed at baseline and follow-up examinations.
Gains in weight and WC associated with pregnancy and childbearing varied by race (P<0.001), baseline parity (P<0.05) and overweight status (P<0.001). Among overweight nulliparas, excess gains in weight (black subjects: 3–5 kg, white subjects: 5–6 kg) and WC (black subjects: 3–4 cm, white subjects: 5–6 cm) were associated with ‘short’ pregnancies and one or more birth(s) during follow-up compared to no pregnancies (P<0.01 and 0.001). Among normal weight nulliparas, excess gains in weight (about 1 kg) and WC (2–3 cm) were associated with follow-up birth(s) (P<0.05). Among women parous at baseline, no excess weight gains were found, but excess WC gains (2–4 cm) were associated with follow-up births.
Substantial excess weight gain is associated with both short pregnancies and a first birth in women overweight prior to initiation of childbearing. Excess weight gain was not associated with higher order births. Increases in waist girth were cumulative with both first and higher order births among overweight as well as normal weight women. Interventions to prevent obesity should be targeted at women who are overweight prior to initiation of childbearing. The impact of excess WC gains associated with childbearing on women’s future health risk should be evaluated further.
PMCID: PMC3133634  PMID: 14770188
medical subject headings; central adiposity; obesity; parity; pregnancy; weight gain; waist circumference
17.  Associations of trimester-specific gestational weight gain with maternal adiposity and systolic blood pressure at 3 and 7 years postpartum 
American journal of obstetrics and gynecology  2014;212(4):499.e1-499.e12.
Our objective was to examine the associations of total and trimester-specific gestational weight gain (GWG) rate with postpartum maternal weight and cardiometabolic risk. We hypothesized the first trimester GWG would be most strongly associated with long-term maternal health.
We studied 801 women enrolled during the 1st trimester of pregnancy in the Boston-area Project Viva cohort 1999–2002. At 3 years postpartum we measured maternal weight, waist circumference, and systolic blood pressure (SBP) and collected fasting blood from a subset. At 7 years postpartum we again measured weight and waist circumference. We used multivariable linear regression to evaluate relations of total and trimester-specific GWG rate with weight change (vs. self-reported pre-pregnancy weight) and waist circumference at each timepoint, stratified by pre-pregnancy weight, as well as associations with SBP and insulin resistance at 3 years.
Median age at enrollment was 34.0 years (range: 16.4–44.9); 65% were white. Mean (SD) total GWG rate was 0.38 (0.14) kg/week. Women gained weight faster during the second (0.47 [0.19] kg/week) and third trimesters (0.44 [0.22] kg/week) than the first (0.22 [0.22] kg/week). Total and first trimester GWG rate were most strongly associated with postpartum weight change. Among normal weight women, each 1 SD increase in total and first trimester GWG rate corresponded with 0.85 (95% CI: 0.07, 1.63) kg and 2.08 (1.32, 2.84) kg greater weight change at 3 and 7 years postpartum respectively, but there was not strong evidence of association for either second (−0.30 kg; 95% CI: −1.08, 0.48) or third trimester (−0.26 kg; 95% CI: −1.08, 0.55) GWG. First trimester GWG rate also related to 3-year postpartum weight change in overweight (2.28 kg; 95% CI: 0.95, 3.61) and obese (2.47 kg; 95% CI: 0.98, 3.97) women. Greater total and first trimester GWG rate were associated with larger waist circumference and higher SBP but not insulin resistance.
In this observational cohort, first trimester weight gain was more strongly associated with maternal weight retention as well as higher waist circumference and blood pressure than 2nd or 3rd trimester gain. Interventions targeting GWG beginning very early in pregnancy may benefit long-term maternal health.
PMCID: PMC4387018  PMID: 25446696
Gestational weight gain; cardiometabolic health; postpartum period; pregnancy
18.  A Nested Case–Control Study of Metabolically Defined Body Size Phenotypes and Risk of Colorectal Cancer in the European Prospective Investigation into Cancer and Nutrition (EPIC) 
PLoS Medicine  2016;13(4):e1001988.
Obesity is positively associated with colorectal cancer. Recently, body size subtypes categorised by the prevalence of hyperinsulinaemia have been defined, and metabolically healthy overweight/obese individuals (without hyperinsulinaemia) have been suggested to be at lower risk of cardiovascular disease than their metabolically unhealthy (hyperinsulinaemic) overweight/obese counterparts. Whether similarly variable relationships exist for metabolically defined body size phenotypes and colorectal cancer risk is unknown.
Methods and Findings
The association of metabolically defined body size phenotypes with colorectal cancer was investigated in a case–control study nested within the European Prospective Investigation into Cancer and Nutrition (EPIC) study. Metabolic health/body size phenotypes were defined according to hyperinsulinaemia status using serum concentrations of C-peptide, a marker of insulin secretion. A total of 737 incident colorectal cancer cases and 737 matched controls were divided into tertiles based on the distribution of C-peptide concentration amongst the control population, and participants were classified as metabolically healthy if below the first tertile of C-peptide and metabolically unhealthy if above the first tertile. These metabolic health definitions were then combined with body mass index (BMI) measurements to create four metabolic health/body size phenotype categories: (1) metabolically healthy/normal weight (BMI < 25 kg/m2), (2) metabolically healthy/overweight (BMI ≥ 25 kg/m2), (3) metabolically unhealthy/normal weight (BMI < 25 kg/m2), and (4) metabolically unhealthy/overweight (BMI ≥ 25 kg/m2). Additionally, in separate models, waist circumference measurements (using the International Diabetes Federation cut-points [≥80 cm for women and ≥94 cm for men]) were used (instead of BMI) to create the four metabolic health/body size phenotype categories. Statistical tests used in the analysis were all two-sided, and a p-value of <0.05 was considered statistically significant. In multivariable-adjusted conditional logistic regression models with BMI used to define adiposity, compared with metabolically healthy/normal weight individuals, we observed a higher colorectal cancer risk among metabolically unhealthy/normal weight (odds ratio [OR] = 1.59, 95% CI 1.10–2.28) and metabolically unhealthy/overweight (OR = 1.40, 95% CI 1.01–1.94) participants, but not among metabolically healthy/overweight individuals (OR = 0.96, 95% CI 0.65–1.42). Among the overweight individuals, lower colorectal cancer risk was observed for metabolically healthy/overweight individuals compared with metabolically unhealthy/overweight individuals (OR = 0.69, 95% CI 0.49–0.96). These associations were generally consistent when waist circumference was used as the measure of adiposity. To our knowledge, there is no universally accepted clinical definition for using C-peptide level as an indication of hyperinsulinaemia. Therefore, a possible limitation of our analysis was that the classification of individuals as being hyperinsulinaemic—based on their C-peptide level—was arbitrary. However, when we used quartiles or the median of C-peptide, instead of tertiles, as the cut-point of hyperinsulinaemia, a similar pattern of associations was observed.
These results support the idea that individuals with the metabolically healthy/overweight phenotype (with normal insulin levels) are at lower colorectal cancer risk than those with hyperinsulinaemia. The combination of anthropometric measures with metabolic parameters, such as C-peptide, may be useful for defining strata of the population at greater risk of colorectal cancer.
Gunter and colleagues analyse a large European dataset to determine how body size and metabolic profile associates with the risk of developing colorectal cancer.
Editors' Summary
Colorectal cancer is the third most common cancer worldwide and is a leading cause of cancer-related death, killing around 700,000 people every year. It develops when cells in the colon (the final part of the digestive system, which is also known as the large intestine or large bowel) or the rectum (the lower end of the colon) acquire genetic changes that allow them to divide uncontrollably to form a tumor and to move around the body (metastasize). Symptoms of colorectal cancer include blood in the stool, a change in bowel habits, and unexplained weight loss. Treatments for colorectal cancer include surgery, chemotherapy, and radiation. As with other types of cancer, these treatments are more likely to be successful if started when the tumor is very small. Consequently, many countries run screening programs that use colonoscopy, the fecal occult blood test, and other tests to detect the earliest signs of colorectal cancer in apparently healthy people.
Why Was This Study Done?
Being obese—having too much body fat—is associated with an increased colorectal cancer risk (other risk factors include age, having a family history of colorectal cancer, and eating a high-fat, low-fiber diet). Obesity is also associated with several other chronic diseases, and recent evidence suggests that some obese individuals have a higher risk of developing these diseases than others. For example, overweight/obese individuals who have hyperinsulinemia (abnormally high blood levels of insulin; “metabolically unhealthy”) seem to have a higher risk of cardiovascular disease than their non-hyperinsulinemic (“metabolically healthy”) overweight counterparts. If certain combinations of metabolic health status and body size (“metabolically defined body size phenotypes”) are also associated with colorectal cancer, measurement of insulin levels in conjunction with body fat (adiposity) measurements such as body mass index (BMI; an indicator of body fat calculated by dividing a person’s weight in kilograms by their height in meters squared) might improve colorectal cancer risk assessment. In this nested case–control study, the researchers assess the associations between metabolically defined body size phenotypes and colorectal cancer risk. A nested case–control study identifies everyone in a group (here, participants in the European Prospective Investigation into Cancer and Nutrition [EPIC] study) who has a specific condition, identifies matched individuals in the same group without the condition, and asks whether these controls and the cases differ in terms of a specific characteristic or outcome.
What Did the Researchers Do and Find?
The researchers matched 737 participants in the EPIC study who developed colorectal cancer after study enrollment with 737 controls and used serum concentrations of C-peptide, a marker of insulin secretion, and BMI measurements to classify each individual as metabolically healthy/normal weight, metabolically healthy/overweight, metabolically unhealthy/normal weight, or metabolically unhealthy/overweight. Specifically, the researchers categorized people as metabolically unhealthy if they had a C-peptide level above an arbitrarily chosen cut-off value based on the distribution of C-peptide levels in the control participants and as overweight if they had a BMI of ≥25 kg/m2 (the standard definition of overweight). Compared to metabolically healthy normal weight individuals, metabolically unhealthy normal weight and overweight individuals had an increased colorectal cancer risk; metabolically healthy overweight individuals had a similar colorectal cancer risk to metabolically healthy normal weight individuals. Among overweight individuals, metabolically healthy individuals had a lower colorectal cancer risk than metabolically unhealthy individuals. Finally, similar associations were seen when the researchers used waist circumference instead of BMI as the measure of adiposity.
What Do These Findings Mean?
These findings suggest that normal weight individuals with hyperinsulinemia (the metabolically unhealthy normal weight phenotype) have a higher risk of colorectal cancer than normal weight individuals without hyperinsulinemia. They also suggest that metabolically unhealthy overweight individuals have a higher risk of colorectal cancer than metabolically healthy overweight individuals. The accuracy of these findings may be limited by the method the researchers used to classify individuals as hyperinsulinemic—there is no universally accepted clinical definition for using C-peptide level to diagnose hyperinsulinemia. Nevertheless, these findings suggest that the assessment of insulin levels in conjunction with adiposity measures might be a better way to assess an individual’s colorectal cancer risk than simply measuring adiposity, and might help to identify those individuals at high risk of colorectal cancer who are most likely to benefit from targeted interventions designed to prevent the onset of clinical disease.
Additional Information
This list of resources contains links that can be accessed when viewing the PDF on a device or via the online version of the article at
The US National Cancer Institute provides information for patients about all aspects of colorectal cancer; it also provides more detailed information colorectal cancer for health professionals and information on cancer risk and obesity
The UK National Health Service Choices website has information and personal stories about colorectal cancer and information on obesity
The not-for-profit organization Cancer Research UK provides information about colorectal cancer and about the association between cancer and obesity
MedlinePlus provides links to further resources about colorectal cancer and about obesity
Wikipedia has a page on hyperinsulinemia (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
More information about the EPIC study is available
PMCID: PMC4821615  PMID: 27046222
19.  Anthropometric measures and cognition in middle-aged HIV-infected and uninfected women. The Women's Interagency HIV Study 
Journal of neurovirology  2013;19(6):574-585.
To explore the relationship of body mass index (BMI), waist circumference (WC), and waist-to-hip ratio (WHR) with cognition in women with (HIV+) and without HIV (HIV-) infection.
1690 participants (1196 HIV+, 494 HIV-) in the Women's Interagency HIV Study (WIHS) with data available on anthropometric measures comprise the analytical sample. Cross-sectional analyses using linear regression models estimated the relationship between anthropometric variables and Trails A, Trails B, Stroop interference time, Stroop word recall, Stroop color naming and reading, and Symbol Digit Modalities Test (SDMT) with consideration for age, HIV infection status, Wide Range Achievement Test score, CD4 count, insulin resistance, drug use, and race/ethnicity.
Among HIV+ women, BMI < 18.5 kg/m2 was associated with poorer cognitive performance evidenced by longer Trails A and Trails B and shorter SDMT completion times. An obese BMI (30 kg/m2 or higher) was related to better performance on Trails B and worse performance on the Stroop Interference test. Among HIV- women, an obese BMI was related to worse performance on the Stroop – Color naming test. Few and inconsistent associations were observed between WC, WHR and cognition.
Among women at mid-life with chronic (at least 10 years) HIV infection, common anthropometric measures, primarily BMI, were differentially related to cognitive test performance by cognitive domain. Higher levels of BMI were associated with better cognitive function. In this era of antiretroviral therapies, restoration of health evidenced as higher BMI due to effective antiretroviral therapies, may improve cognitive function in middle-aged HIV infected women.
PMCID: PMC3957488  PMID: 24338243
Cognition; HIV; Women; Overweight; Obesity; Middle-Aged
20.  Pregnancy Weight Gain and Childhood Body Weight: A Within-Family Comparison 
PLoS Medicine  2013;10(10):e1001521.
David Ludwig and colleagues examine the within-family relationship between pregnancy weight gain and the offspring's childhood weight gain, thereby reducing the influence of genes and environment.
Please see later in the article for the Editors' Summary
Excessive pregnancy weight gain is associated with obesity in the offspring, but this relationship may be confounded by genetic and other shared influences. We aimed to examine the association of pregnancy weight gain with body mass index (BMI) in the offspring, using a within-family design to minimize confounding.
Methods and Findings
In this population-based cohort study, we matched records of all live births in Arkansas with state-mandated data on childhood BMI collected in public schools (from August 18, 2003 to June 2, 2011). The cohort included 42,133 women who had more than one singleton pregnancy and their 91,045 offspring. We examined how differences in weight gain that occurred during two or more pregnancies for each woman predicted her children's BMI and odds ratio (OR) of being overweight or obese (BMI≥85th percentile) at a mean age of 11.9 years, using a within-family design. For every additional kg of pregnancy weight gain, childhood BMI increased by 0.0220 (95% CI 0.0134–0.0306, p<0.0001) and the OR of overweight/obesity increased by 1.007 (CI 1.003–1.012, p = 0.0008). Variations in pregnancy weight gain accounted for a 0.43 kg/m2 difference in childhood BMI. After adjustment for birth weight, the association of pregnancy weight gain with childhood BMI was attenuated but remained statistically significant (0.0143 kg/m2 per kg of pregnancy weight gain, CI 0.0057–0.0229, p = 0.0007).
High pregnancy weight gain is associated with increased body weight of the offspring in childhood, and this effect is only partially mediated through higher birth weight. Translation of these findings to public health obesity prevention requires additional study.
Please see later in the article for the Editors' Summary
Editors' Summary
Childhood obesity has become a worldwide epidemic. For example, in the United States, the number of obese children has more than doubled in the past 30 years. 7% of American children aged 6–11 years were obese in 1980, compared to nearly 18% in 2010. Because of the rising levels of obesity, the current generation of children may have a shorter life span than their parents for the first time in 200 years.
Childhood obesity has both immediate and long-term effects on health. The initial problems are usually psychological. Obese children often experience discrimination, leading to low self-esteem and depression. Their physical health also suffers. They are more likely to be at risk of cardiovascular disease from high cholesterol and high blood pressure. They may also develop pre-diabetes or diabetes type II. In the long-term, obese children tend to become obese adults, putting them at risk of premature death from stroke, heart disease, or cancer.
There are many factors that lead to childhood obesity and they often act in combination. A major risk factor, especially for younger children, is having at least one obese parent. The challenge lies in unravelling the complex links between the genetic and environmental factors that are likely to be involved.
Why Was This Study Done?
Several studies have shown that a child's weight is influenced by his/her mother's weight before pregnancy and her weight gain during pregnancy. An obese mother, or a mother who puts on more pregnancy weight than average, is more likely to have an obese child.
One explanation for the effects of pregnancy weight gain is that the mother's overeating directly affects the baby's development. It may change the baby's brain and metabolism in such a way as to increase the child's long-term risk of obesity. Animal studies have confirmed that the offspring of overfed rats show these kinds of physiological changes. However, another possible explanation is that mother and baby share a similar genetic make-up and environment so that a child becomes obese from inheriting genetic risk factors, and growing up in a household where being overweight is the norm.
The studies in humans that have been carried out to date have not been able to distinguish between these explanations. Some have given conflicting results. The aim of this study was therefore to look for evidence of links between pregnancy weight gain and children's weight, using an approach that would separate the impact of genetic and environmental factors from a direct effect on the developing baby.
What Did the Researchers Do and Find?
The researchers examined data from the population of the US state of Arkansas recorded between 2003 and 2011. They looked at the health records of over 42,000 women who had given birth to more than one child during this period. This gave them information about how much weight the women had gained during each of their pregnancies. The researchers also looked at the school records of the children, over 91,000 in total, which included the children's body mass index (BMI, which factors in both height and weight). They analyzed the data to see if there was a link between the mothers' pregnancy weight gain and the child's BMI at around 12 years of age. Most importantly, they looked at these links within families, comparing children born to the same mother. The rationale for this approach was that these children would share a similar genetic make-up and would have grown up in similar environments. By taking genetics and environment into account in this manner, any remaining evidence of an impact of pregnancy weight gain on the children's BMI would have to be explained by other factors.
The results showed that the amount of weight each mother gained in pregnancy predicted her children's BMI and the likelihood of her children being overweight or obese. For every additional kg the mother gained during pregnancy, the children's BMI increased by 0.022. The children of mothers who put on the most weight had a BMI that was on average 0.43 higher than the children whose mothers had put on the least weight.
The study leaves some questions unanswered, including whether the mother's weight before pregnancy makes a difference to their children's BMI. The researchers were not able to obtain these measurements, nor the weight of the fathers. There may have also been other factors that weren't measured that might explain the links that were found.
What Do These Findings Mean?
This study shows that mothers who gain excessive weight during pregnancy increase the risk of their child becoming obese. This appears to be partly due to a direct effect on the developing baby.
These results represent a significant public health concern, even though the impact on an individual basis is relatively small. They could contribute to several hundred thousand cases of childhood obesity worldwide. Importantly, they also suggest that some cases could be prevented by measures to limit excessive weight gain during pregnancy. Such an approach could prove effective, as most mothers will not want to damage their child's health, and might therefore be highly motivated to change their behavior. However, because inadequate weight gain during pregnancy can also adversely affect the developing fetus, it will be essential for women to receive clear information about what constitutes optimal weight gain during pregnancy.
Additional Information
Please access these websites via the online version of this summary at
The US Centers for Disease Control and Prevention provide Childhood Obesity Facts
The UK National Health Service article “How much weight will I put on during my pregnancy?” provides information on pregnancy and weight gain and links to related resources
PMCID: PMC3794857  PMID: 24130460
21.  Computerized Cognitive Training in Cognitively Healthy Older Adults: A Systematic Review and Meta-Analysis of Effect Modifiers 
PLoS Medicine  2014;11(11):e1001756.
Michael Valenzuela and colleagues systematically review and meta-analyze the evidence that computerized cognitive training improves cognitive skills in older adults with normal cognition.
Please see later in the article for the Editors' Summary
New effective interventions to attenuate age-related cognitive decline are a global priority. Computerized cognitive training (CCT) is believed to be safe and can be inexpensive, but neither its efficacy in enhancing cognitive performance in healthy older adults nor the impact of design factors on such efficacy has been systematically analyzed. Our aim therefore was to quantitatively assess whether CCT programs can enhance cognition in healthy older adults, discriminate responsive from nonresponsive cognitive domains, and identify the most salient design factors.
Methods and Findings
We systematically searched Medline, Embase, and PsycINFO for relevant studies from the databases' inception to 9 July 2014. Eligible studies were randomized controlled trials investigating the effects of ≥4 h of CCT on performance in neuropsychological tests in older adults without dementia or other cognitive impairment. Fifty-two studies encompassing 4,885 participants were eligible. Intervention designs varied considerably, but after removal of one outlier, heterogeneity across studies was small (I2 = 29.92%). There was no systematic evidence of publication bias. The overall effect size (Hedges' g, random effects model) for CCT versus control was small and statistically significant, g = 0.22 (95% CI 0.15 to 0.29). Small to moderate effect sizes were found for nonverbal memory, g = 0.24 (95% CI 0.09 to 0.38); verbal memory, g = 0.08 (95% CI 0.01 to 0.15); working memory (WM), g = 0.22 (95% CI 0.09 to 0.35); processing speed, g = 0.31 (95% CI 0.11 to 0.50); and visuospatial skills, g = 0.30 (95% CI 0.07 to 0.54). No significant effects were found for executive functions and attention. Moderator analyses revealed that home-based administration was ineffective compared to group-based training, and that more than three training sessions per week was ineffective versus three or fewer. There was no evidence for the effectiveness of WM training, and only weak evidence for sessions less than 30 min. These results are limited to healthy older adults, and do not address the durability of training effects.
CCT is modestly effective at improving cognitive performance in healthy older adults, but efficacy varies across cognitive domains and is largely determined by design choices. Unsupervised at-home training and training more than three times per week are specifically ineffective. Further research is required to enhance efficacy of the intervention.
Please see later in the article for the Editors' Summary
Editors' Summary
As we get older, we notice many bodily changes. Our hair goes grey, we develop new aches and pains, and getting out of bed in the morning takes longer than it did when we were young. Our brain may also show signs of aging. It may take us longer to learn new information, we may lose our keys more frequently, and we may forget people's names. Cognitive decline—developing worsened thinking, language, memory, understanding, and judgment—can be a normal part of aging, but it can also be an early sign of dementia, a group of brain disorders characterized by a severe, irreversible decline in cognitive functions. We know that age-related physical decline can be attenuated by keeping physically active; similarly, engaging in activities that stimulate the brain throughout life is thought to enhance cognition in later life and reduce the risk of age-related cognitive decline and dementia. Thus, having an active social life and doing challenging activities that stimulate both the brain and the body may help to stave off cognitive decline.
Why Was This Study Done?
“Brain training” may be another way of keeping mentally fit. The sale of computerized cognitive training (CCT) packages, which provide standardized, cognitively challenging tasks designed to “exercise” various cognitive functions, is a lucrative and expanding business. But does CCT work? Given the rising global incidence of dementia, effective interventions that attenuate age-related cognitive decline are urgently needed. However, the impact of CCT on cognitive performance in older adults is unclear, and little is known about what makes a good CCT package. In this systematic review and meta-analysis, the researchers assess whether CCT programs improve cognitive test performance in cognitively healthy older adults and identify the aspects of cognition (cognitive domains) that are responsive to CCT, and the CCT design features that are most important in improving cognitive performance. A systematic review uses pre-defined criteria to identify all the research on a given topic; meta-analysis uses statistical methods to combine the results of several studies.
What Did the Researchers Do and Find?
The researchers identified 51 trials that investigated the effects of more than four hours of CCT on nearly 5,000 cognitively healthy older adults by measuring several cognitive functions before and after CCT. Meta-analysis of these studies indicated that the overall effect size for CCT (compared to control individuals who did not participate in CCT) was small but statistically significant. An effect size quantifies the difference between two groups; a statistically significant result is a result that is unlikely to have occurred by chance. So, the meta-analysis suggests that CCT slightly increased overall cognitive function. Notably, CCT also had small to moderate significant effects on individual cognitive functions. For example, some CCT slightly improved nonverbal memory (the ability to remember visual images) and working memory (the ability to remember recent events; short-term memory). However, CCT had no significant effect on executive functions (cognitive processes involved in planning and judgment) or attention (selective concentration on one aspect of the environment). The design of CCT used in the different studies varied considerably, and “moderator” analyses revealed that home-based CCT was not effective, whereas center-based CCT was effective, and that training sessions undertaken more than three times a week were not effective. There was also some weak evidence suggesting that CCT sessions lasting less than 30 minutes may be ineffective. Finally, there was no evidence for the effectiveness of working memory training by itself (for example, programs that ask individuals to recall series of letters).
What Do These Findings Mean?
These findings suggest that CCT produces small improvements in cognitive performance in cognitively healthy older adults but that the efficacy of CCT varies across cognitive domains and is largely determined by design aspects of CCT. The most important result was that “do-it-yourself” CCT at home did not produce improvements. Rather, the small improvements seen were in individuals supervised by a trainer in a center and undergoing sessions 1–3 times a week. Because only cognitively healthy older adults were enrolled in the studies considered in this systematic review and meta-analysis, these findings do not necessarily apply to cognitively impaired individuals. Moreover, because all the included studies measured cognitive function immediately after CCT, these findings provide no information about the durability of the effects of CCT or about how the effects of CCT on cognitive function translate into real-life outcomes for individuals such as independence and the long-term risk of dementia. The researchers call, therefore, for additional research into CCT, an intervention that might help to attenuate age-related cognitive decline and improve the quality of life for older individuals.
Additional Information
Please access these websites via the online version of this summary at
This study is further discussed in a PLOS Medicine Perspective by Druin Burch
The US National Institute on Aging provides information for patients and carers about age-related forgetfulness, about memory and cognitive health, and about dementia (in English and Spanish)
The UK National Health Service Choices website also provides information about dementia and about memory loss
MedlinePlus provides links to additional resources about memory, mild cognitive impairment, and dementia (in English and Spanish)
PMCID: PMC4236015  PMID: 25405755
22.  Waist-to-Height Ratio as a Predictor of Coronary Heart Disease among Women 
Epidemiology (Cambridge, Mass.)  2009;20(3):361-366.
The aim of our study is to prospectively evaluate and compare the waist circumference-to-height ratio (WHtR) to waist-hip ratio, waist circumference, and body mass index as predictors of subsequent coronary heart disease (CHD) in a group of predominantly post-menopausal women.
The data comes from a prospective cohort study. The included subjects were 45563 women from the Nurses' Health Study cohort, aged 40-65 years in 1986, who were free of heart disease, stroke and cancer. Waist circumference, hip circumference, height, weight, age, and other covariates were collected by questionnaire. The primary endpoint was incident coronary heart disease that was reported by June 2002. Areas under the receiver operating characteristic curves (AUC) were estimated non-parametrically for each of anthropometric measures, and differences between that for WHtR and the other measures, and corresponding 95% confidence intervals were estimated. Cox proportional hazard models were used to estimate the relationships with risk of CHD.
Waist-height ratio, waist-hip ratio and waist circumference were similar in predicting subsequent risk of CHD. All three waist derived measures were superior to BMI in predicting CHD. The unadjusted AUC (95% Confidence Interval) were 0.62 (0.60,0.64) for WHtR, 0.63 (0.61,0.65) for waist-hip ratio, 0.62 (0.60,0.64) for waist-circumference, and 0.57 (0.55,0.59) for body mass index.
Waist-height ratio is comparable to waist circumference and waist-hip ratio for prediction of coronary heart disease incidence among middle-aged and older women, but superior to BMI. Future studies are warranted to corroborate these results in other populations.
PMCID: PMC4012298  PMID: 19289960
23.  Proceedings of the Thirteenth International Society of Sports Nutrition (ISSN) Conference and Expo 
Ramaswamy, Lalitha | Velraja, Supriya | Escalante, Guillermo | Harvey, Phil | Alencar, Michelle | Haddock, Bryan | Harvey, Phil | Escalante, Guillermo | Alencar, Michelle | Haddock, Bryan | Durkalec-Michalski, Krzysztof | Jeszka, Jan | Zawieja, Bogna | Podgórski, Tomasz | Trussardi Fayh, Ana Paula | Okano, Alexandre Hideki | de Jesus Ferreira, Amanda Maria | Jäger, Ralf | Purpura, Martin | Harris, Roger C. | Krause, Molly M. | Lavanger, Kiley A. | Allen, Nina O. | Lieb, Allison E. | Mullen, Katie A. | Eckerson, Joan M. | Lavanger, Kiley A. | Krause, Molly M. | Allen, Nina O. | Lieb, Allison E. | Mullen, Katie A. | Eckerson, Joan M. | Morales, Elisa | Forsse, Jeffrey | Andre, Thomas | McKinley, Sarah | Hwang, Paul | Tinsley, Grant | Spillane, Mike | Grandjean, Peter | Willoughby, Darryn | Jagim, A. | Wright, G. | Kisiolek, J. | Meinking, M. | Ochsenwald, J. | Andre, M. | Jones, M. T. | Oliver, J. M. | Ferreira, Victor Araújo | de Souza, Daniel Costa | dos Santos, Victor Oliveira Albuquerque | Browne, Rodrigo Alberto Vieira | Costa, Eduardo Caldas | Fayh, Ana Paula Trussardi | Mathews, Suresh T. | Bishop, Haley D. | Bowen, Clara R. | Liang, Yishan | West, Emily A. | Rogers, Rebecca R. | Marshall, Mallory R. | Petrella, John K. | Holland, A. Maleah | Kephart, Wesley C. | Mumford, Petey W. | Mobley, C. Brooks | Lowery, Ryan P. | Wilson, Jacob M. | Roberts, Michael D. | Trexler, Eric T. | Hirsch, Katie R. | Campbell, Bill I. | Mock, Meredith G. | Smith-Ryan, Abbie E. | Zemek, Kate | Johnston, Carol | Mobley, C. Brooks | Mumford, Petey W. | Pascoe, David D. | Lockwood, Christopher M. | Miller, Michael E. | Roberts, Michael D. | Sanders, Gabriel J. | Peveler, Willard | Warning, Brooke | Peacock, Corey A. | Kephart, Wesley C. | Mumford, Petey W. | Lowery, Ryan P. | Roberts, Michael D. | Wilson, Jacob M. | Sandler, David | Ojalvo, Sara Perez | Komorowski, James | Campbell, Bill I. | Aguilar, Danielle | Vargas, Andres | Conlin, Laurin | Sanders, Amey | Fink-Irizarry, Paola | Norton, Layne | Perry, Ross | McCallum, Ryley | Wynn, Matthew R. | Lenton, Jack | Campbell, Bill I. | Gai, Chris | Donelson, Seth | Best, Shiva | Bove, Daniel | Couvillion, Kaylee | Dolan, Jeff | Xing, Dante | Chernesky, Kyshia | Pawela, Michael | Toledo, Andres D. | Jimenez, Rachel | Rabideau, M. | Walker, A. | Pellegrino, J. | Hofacker, M. | McFadden, B. | Conway, S. | Ordway, C. | Sanders, D. | Monaco, R. | Fragala, M. S. | Arent, S. M. | Stone, Jason D. | Kreutzer, Andreas | Oliver, Jonathan M. | Kisiolek, Jacob | Jagim, Andrew R. | Hofacker, M. | Walker, A. | Pellegrino, J. | Rabideau, M. | McFadden, B. | Conway, S. | Sanders, D. | Ordway, C. | Monaco, R. | Fragala, M. S. | Arent, S. M. | Tok, Ozlem | Pellegrino, Joseph K. | Walker, Alan J. | Sanders, David J. | McFadden, Bridget A. | Rabideau, Meaghan M. | Conway, Sean P. | Ordway, Chris E. | Bello, Marissa | Hofacker, Morgan L. | Mackowski, Nick S. | Poyssick, Anthony J. | Capone, Eddie | Monaco, Robert M. | Fragala, Maren S. | Arent, Shawn M. | Mumford, Petey W. | Holland, A. Maleah | Kephart, Wesley C. | Lowery, Ryan P. | Mobley, C. Brooks | Patel, Romil K. | Newton, Annie | Beck, Darren T. | Roberts, Michael D. | Wilson, Jacob M. | Young, Kaelin C. | Silver, Tobin | Ellerbroek, Anya | Buehn, Richard | Vargas, Leo | Tamayo, Armando | Peacock, Corey | Antonio, Jose | Ellerbroek, Anya | Silver, Tobin | Buehn, Richard | Vargas, Leo | Tamayo, Armando | Peacock, Corey | Antonio, Jose | Pollock, Adam | Ellerbroek, Anya | Silver, Tobin | Peacock, Corey | Antonio, Jose | Kreutzer, A. | Zavala, P. | Fleming, S. | Jones, M. | Oliver, J. M. | Jagim, A. | Haun, Cody T. | Mumford, Petey W. | Hyde, Parker N. | Fairman, Ciaran M. | Kephart, Wesley C. | Beck, Darren T. | Moon, Jordan R. | Roberts, Michael D. | Kendall, Kristina L. | Young, Kaelin C. | Hudson, Geoffrey M. | Hannings, Tara | Sprow, Kyle | DiPietro, Loretta | Kalman, Doug | Ojalvo, Sara Perez | Komorowski, James | Zavala, P. | Fleming, S. | Jones, M. | Oliver, J. | Jagim, A. | Wallace, Brian | Bergstrom, Haley | Wallace, Kelly | Monsalves-Alvarez, Matias | Oyharçabal, Sebastian | Espinoza, Victoria | VanDusseldorp, Trisha A. | Escobar, Kurt A. | Johnson, Kelly E. | Cole, Nathan | Moriarty, Terence | Stratton, Matthew | Endito, Marvin R. | Mermier, Christine M. | Kerksick, Chad M. | Romero, Matthew A. | Mobley, C. Brooks | Linden, Melissa | Meers, Grace Margaret-Eleanor | Rector, R. Scott | Roberts, Michael D. | Gills, Joshua L | Lu, Hocheng | Parker, Kimberly | Dobbins, Chris | Guillory, Joshua N. | Romer, Braden | Szymanski, David | Glenn, Jordan | Newmire, Daniel E. | Rivas, Eric | Deemer, Sarah E. | Wildman, Robert | Ben-Ezra, Victor | Kerksick, C. | Gieske, B. | Stecker, R. | Smith, C. | Witherbee, K. | Lane, Michael T. | Byrd, M. Travis | Bell, Zachary | Frith, Emily | Lane, Lauren M. C. | Lane, Michael T. | Byrd, M. Travis | Bell, Zachary | Frith, Emily | Lane, Lauren M. C. | Peacock, Corey A. | Silver, Tobin A. | Colas, Megan | Mena, Mauricio | Rodriguez, Winter | Sanders, Gabriel J. | Antonio, Jose | Vansickle, Andrea | DiFiore, Brittany | Stepp, Stephanie | Slack, Grant | Smith, Bridget | Ruffner, Kayla | Mendel, Ronald | Lowery, Lonnie | Hirsch, Katie R. | Mock, Meredith G. | Blue, Malia M. N. | Trexler, Eric T. | Roelofs, Erica J. | Smith-Ryan, Abbie E. | Conlin, Laurin | Aguilar, Danielle | Campbell, Bill I. | Norton, Layne | Coles, Katie | Trexler, Eric T. | Martinez, Nic | Joy, Jordan M. | Vogel, Roxanne M. | Hoover, Thomas H. | Broughton, K. Shane | Dalton, R. | Sowinski, R. | Grubic, T. | Collins, P. B. | Colletta, A. | Reyes, A. | Sanchez, B. | Kozehchain, M. | Jung, Y. P. | Rasmussen, C. | Murano, P. | Earnest, C. P. | Greenwood, M. | Kreider, R. B. | Grubic, T. | Dalton, R. | Sowinski, R. | Collins, P. B. | Colletta, A. | Reyes, A. | Sanchez, B. | Kozehchain, M. | Jung, Y. P. | Rasmussen, C. | Murano, P. | Earnest, C. P. | Greenwood, M. | Kreider, R. B. | Sowinski, R. | Dalton, R. | Grubic, T. | Collins, P. B. | Colletta, A. | Reyes, A. | Sanchez, B. | Kozehchain, M. | Jung, Y. P. | Rasmussen, C. | Murano, P. | Earnest, C. P. | Greenwood, M. | Kreider, R. B. | Durkalec-Michalski, Krzysztof | Jeszka, Jan | Podgórski, Tomasz | Kerksick, C. | Gieske, B. | Stecker, R. | Smith, C. | Witherbee, K. | Urbina, Stacie | Santos, Emily | Villa, Katelyn | Olivencia, Alyssa | Bennett, Haley | Lara, Marissa | Foster, Cliffa | Wilborn, Colin | Taylor, Lem | Cholewa, Jason M | Hewins, Amy | Gallo, Samantha | Micensky, Ashley | de Angelis, Christian | Carney, Christopher | Campbell, Bill | Conlin, Laurin | Norton, Layne | Rossi, Fabricio | Koozehchian, M. S. | Collins, P. B. | Sowinski, R. | Grubic, T. | Dalton, R. | O’Connor, A. | Shin, S. Y. | Jung, Y. Peter | Sanchez, B. K. | Coletta, A. | Cho, M. | Reyes, A. | Rasmussen, C. | Earnest, C. P. | Murano, P. S. | Greenwood, M. | Kreider, R. B.
Table of contents
P1 Impact of antioxidant-enriched nutrient bar supplementation on the serum antioxidant markers and physical fitness components of track and field athletes
Lalitha Ramaswamy, Supriya Velraja
P2 The effects of phosphatidic acid supplementation on fitness levels in resistance trained women
Guillermo Escalante, Phil Harvey, Michelle Alencar, Bryan Haddock
P3 The effects of phosphatidic acid supplementation on cardiovascular risk factors in resistance trained men
Phil Harvey, Guillermo Escalante, Michelle Alencar, Bryan Haddock
P4 The efficacy of sodium bicarbonate supplementation on physical capacity and selected biochemical markers in elite wrestlers
Krzysztof Durkalec-Michalski, Jan Jeszka, Bogna Zawieja, Tomasz Podgórski
P5 Effects of different nutritional strategies in hydration and physical performance in healthy well-trained males
Ana Paula Trussardi Fayh, Alexandre Hideki Okano, Amanda Maria de Jesus Ferreira
P6 Reduction of plasma creatine concentrations as an indicator of improved bioavailability
Ralf Jäger, Martin Purpura, Roger C Harris
P7 Effect of three different breakfast meals on energy intake and nutritional status in college-age women
Molly M. Krause, Kiley A. Lavanger, Nina O. Allen, Allison E. Lieb, Katie A. Mullen, Joan M. Eckerson
P8 Accuracy of the ASA24® Dietary Recall system for assessing actual dietary intake in normal weight college-age women.
Kiley A. Lavanger, Molly M. Krause, Nina O. Allen, Allison E. Lieb, Katie A. Mullen, Joan M. Eckerson
P9 β-aminoisobutyric acid does not regulate exercise induced UCP-3 expression in skeletal muscle
Elisa Morales, Jeffrey Forsse, Thomas Andre, Sarah McKinley, Paul Hwang, Grant Tinsley, Mike Spillane, Peter Grandjean, Darryn Willoughby
P10 The ability of collegiate football athletes to adhere to sport-specific nutritional recommendations
A. Jagim, G. Wright, J. Kisiolek, M. Meinking, J. Ochsenwald, M. Andre, M.T. Jones, J. M. Oliver
P11 A single session of low-volume high intensity interval exercise improves appetite regulation in overweight men
Victor Araújo Ferreira, Daniel Costa de Souza, Victor Oliveira Albuquerque dos Santos, Rodrigo Alberto Vieira Browne, Eduardo Caldas Costa, Ana Paula Trussardi Fayh
P12 Acute effects of oral peppermint oil ingestion on exercise performance in moderately-active college students
Suresh T. Mathews, Haley D. Bishop, Clara R. Bowen, Yishan Liang, Emily A. West, Rebecca R. Rogers, Mallory R. Marshall, John K. Petrella
P13 Associations in body fat and liver triglyceride content with serum health markers in sedentary and exercised rats fed a ketogenic diet, Western diet or standard chow over a 6-week period
A. Maleah Holland, Wesley C. Kephart, Petey W. Mumford, C. Brooks Mobley, Ryan P. Lowery, Jacob M. Wilson, Michael D. Roberts
P14 Physiological changes following competition in male and female physique athletes: A pilot study
Eric T. Trexler, Katie R. Hirsch, Bill I. Campbell, Meredith G. Mock, Abbie E. Smith-Ryan
P15 Relationship between cognition and hydration status in college students at a large Southwestern university
Kate Zemek, Carol Johnston
P16 Whey protein-derived exosomes increase protein synthesis in C2C12 myotubes
C. Brooks Mobley, Petey W. Mumford, David D. Pascoe, Christopher M. Lockwood, Michael E. Miller, Michael D. Roberts
P17 The effect of three different energy drinks on 1.5-mile running performance, oxygen consumption, and perceived exertion
Gabriel J. Sanders, Willard Peveler, Brooke Warning, Corey A. Peacock
P18 The Ketogenic diet improves rotarod performance in young and older rats
Wesley C. Kephart, Petey W. Mumford, Ryan P. Lowery, Michael D. Roberts, Jacob M. Wilson
P19 Absorption of bonded arginine silicate compared to individual arginine and silicon components
David Sandler, Sara Perez Ojalvo, James Komorowski
P20 Effects of a high (2.4 g/kg) vs. low/moderate (1.2 g/kg) protein intake on body composition in aspiring female physique athletes engaging in an 8-week resistance training program
Bill I. Campbell, Danielle Aguilar, Andres Vargas, Laurin Conlin, Amey Sanders, Paola Fink-Irizarry, Layne Norton, Ross Perry, Ryley McCallum, Matthew R. Wynn, Jack Lenton
P21 Effects of a high (2.4 g/kg) vs. low/moderate (1.2 g/kg) protein intake on maximal strength in aspiring female physique athletes engaging in an 8-week resistance training program
Bill I. Campbell, Chris Gai, Seth Donelson, Shiva Best, Daniel Bove, Kaylee Couvillion, Jeff Dolan, Dante Xing, Kyshia Chernesky, Michael Pawela, Andres D. Toledo, Rachel Jimenez
P22 Monitoring of female collegiate athletes over a competitive season reveals changes in nutritional biomarkers
M. Rabideau, A. Walker, J. Pellegrino, M. Hofacker, B. McFadden, S. Conway, C. Ordway, D. Sanders, R. Monaco, M. S. Fragala, S. M. Arent
P23 Comparison of prediction equations to indirect calorimetry in men and women athletes
Jason D. Stone, Andreas Kreutzer, Jonathan M. Oliver, Jacob Kisiolek, Andrew R. Jagim
P24 Regional variations in sweat-based electrolyte loss and changes in plasma electrolyte content in Division I female athletes over the course of a competitive season
M. Hofacker, A. Walker, J. Pellegrino, M. Rabideau, B. McFadden, S. Conway, D. Sanders, C. Ordway, R. Monaco, M. S. Fragala, S. M. Arent
P25 In-season changes in plasma amino acid levels in Division I NCAA female athletes
Ozlem Tok, Joseph K. Pellegrino, Alan J. Walker, David J. Sanders, Bridget A. McFadden, Meaghan M. Rabideau, Sean P. Conway, Chris E. Ordway, Marissa Bello, Morgan L. Hofacker, Nick S. Mackowski, Anthony J. Poyssick, Eddie Capone, Robert M. Monaco, Maren S. Fragala, Shawn M. Arent
P26 Effects of a ketogenic diet with exercise on serum markers of bone metabolism, IGF-1 and femoral bone mass in rats
Petey W. Mumford, A. Maleah Holland, Wesley C. Kephart, Ryan P. Lowery, C. Brooks Mobley, Romil K. Patel, Annie Newton, Darren T. Beck, Michael D. Roberts, Jacob M. Wilson, Kaelin C. Young
P27 Casein supplementation in trained men and women: morning versus evening
Tobin Silver, Anya Ellerbroek, Richard Buehn, Leo Vargas, Armando Tamayo, Corey Peacock, Jose Antonio
P28 A high protein diet has no harmful effects: a one-year crossover study in resistance-trained males
Anya Ellerbroek, Tobin Silver, Richard Buehn, Leo Vargas, Armando Tamayo, Corey Peacock, Jose Antonio
P29 SUP (Stand-up Paddling) athletes: nutritional intake and body composition
Adam Pollock, Anya Ellerbroek, Tobin Silver, Corey Peacock, Jose Antonio
P30 The effects of 8 weeks of colostrum and bio-active peptide supplementation on body composition in recreational male weight lifters
A. Kreutzer, P. Zavala, S. Fleming, M. Jones, J. M. Oliver, A. Jagim
P31 Effects of a Popular Women’s Thermogenic Supplement During an Energy-Restricted High Protein Diet on Changes in Body Composition and Clinical Safety Markers
Cody T. Haun, Petey W. Mumford, Parker N. Hyde, Ciaran M. Fairman, Wesley C. Kephart, Darren T. Beck, Jordan R. Moon, Michael D. Roberts, Kristina L. Kendall, Kaelin C. Young
P32 Three days of caffeine consumption following caffeine withdrawal yields small strength increase in knee flexors
Geoffrey M Hudson, Tara Hannings, Kyle Sprow, Loretta DiPietro
P33 Comparison of cellular nitric oxide production from various sports nutrition ingredients
Doug Kalman, Sara Perez Ojalvo, James Komorowski
P34 The effects of 8 weeks of bio-active peptide supplementation on training adaptations in recreational male weight lifters
P. Zavala, S. Fleming, M. Jones, J. Oliver, A. Jagim
P35 Effects of MusclePharm Assault BlackTM on lower extremity spinal excitability and postactivation potentiation: A pilot study
Brian Wallace, Haley Bergstrom, Kelly Wallace
P36 Effects of four weeks of Ketogenic Diet alone and combined with High intensity Interval Training or Continuous-Moderate intensity on body composition, lipid profile and physical performance on healthy males
Matias Monsalves-Alvarez, Sebastian Oyharçabal, Victoria Espinoza
P37 Effect of branched-chain amino acid supplementation on creatine kinase, muscular performance, and perceived muscle soreness following acute eccentric exercise
Trisha A. VanDusseldorp, Kurt A. Escobar, Kelly E. Johnson, Nathan Cole, Terence Moriarty, Matthew Stratton, Marvin R. Endito, Christine M. Mermier, Chad M. Kerksick
P38 Effects of endurance training on markers of ribosome biogenesis in rodents fed a high fat diet
Matthew A. Romero, C. Brooks Mobley, Melissa Linden, Grace Margaret-Eleanor Meers, R. Scott Rector, Michael D. Roberts
P39 The effects of acute citrulline-malate on lower-body isokinetic performance in recreationally active individuals
Joshua L Gills, Hocheng Lu, Kimberly Parker, Chris Dobbins, Joshua N Guillory, Braden Romer, David Szymanski, Jordan Glenn
P40 The effect pre-ingested L-isoleucine and L-leucine on blood glucose responses and glycemic hormones in healthy inactive adults: Preliminary data.
Daniel E. Newmire, Eric Rivas, Sarah E. Deemer, Robert Wildman, Victor Ben-Ezra
P41 Does protein and source impact substrate oxidation and energy expenditure during and after moderate intensity treadmill exercise?
C Kerksick, B Gieske, R Stecker, C Smith, K Witherbee
P42 Effects of a pre-workout supplement on peak power and power maintenance during lower and upper body testing
Michael T. Lane, M. Travis Byrd, Zachary Bell, Emily Frith, Lauren M.C. Lane
P43 Effects of a pre-workout supplement on peak power production during lower and upper body testing in college-age females
Michael T. Lane, M. Travis Byrd, Zachary Bell, Emily Frith, Lauren M.C. Lane
P44 A comparison of whey versus casein protein supplementation on resting metabolic rate and body composition: a pilot study
Corey A. Peacock, Tobin A. Silver, Megan Colas, Mauricio Mena, Winter Rodriguez, Gabriel J. Sanders, Jose Antonio
P45 A novel mixed-tocotrienol intervention enhances recovery after eccentric exercise: preliminary findings
Andrea Vansickle, Brittany DiFiore, Stephanie Stepp, Grant Slack, Bridget Smith, Kayla Ruffner, Ronald Mendel, Lonnie Lowery
P46 The effects of post-exercise ingestion of a high molecular weight glucose on cycle performance in female cyclists
Katie R. Hirsch, Meredith G. Mock, Malia M.N. Blue, Eric T. Trexler, Erica J. Roelofs, Abbie E. Smith-Ryan
P47 Inclusive vs. exclusive dieting and the effects on body composition in resistance trained individuals
Laurin Conlin, Danielle Aguilar, Bill I. Campbell, Layne Norton, Katie Coles, Eric T. Trexler, Nic Martinez
P48 A whey protein hydrolysate may positively augment resting metabolism compared to intact whey protein
Jordan M. Joy, Roxanne M. Vogel, Thomas H. Hoover, K. Shane Broughton
P49 Seven days of high and low dose creatine nitrate supplementation I: hepatorenal, glucose and muscle enzyme function
R Dalton, R Sowinski, T Grubic, PB Collins, A Colletta, A Reyes, B Sanchez, M Kozehchain, YP Jung, C Rasmussen, P Murano, CP Earnest, M Greenwood, RB Kreider
P50 Seven days of high and low dose creatine nitrate supplementation II: performance
T Grubic, R Dalton, R Sowinski, PB Collins, A Colletta, A Reyes, B Sanchez, M Kozehchain, YP Jung, C Rasmussen, P Murano, CP Earnest, M Greenwood, RB Kreider
P51 Seven days of high and low dose creatine nitrate supplementation III: hemodynamics
R Sowinski, R Dalton, T Grubic, PB Collins, A Colletta, A Reyes, B Sanchez, M Kozehchain, YP Jung, C Rasmussen, P Murano, CP Earnest, M Greenwood, RB Kreider
P52 The efficacy of a β-hydroxy-β-methylbutyrate supplementation on physical capacity, body composition and biochemical markers in highly-trained combat sports athletes
Krzysztof Durkalec-Michalski, Jan Jeszka, Tomasz Podgórski
P53 Does protein and source impact substrate oxidation and energy expenditure during and after moderate intensity treadmill exercise?
C Kerksick, B Gieske, R Stecker, C Smith, K Witherbee
P54 Effects of 30 days of Cleanse™ supplementation on measure of body composition, waist circumference, and markers of gastrointestinal distress in females
Stacie Urbina, Emily Santos, Katelyn Villa, Alyssa Olivencia, Haley Bennett, Marissa Lara, Cliffa Foster, Colin Wilborn, Lem Taylor
P55 The effects of moderate- versus high-load training on body composition, muscle growth, and performance in college aged females
Jason M Cholewa, Amy Hewins, Samantha Gallo, Ashley Micensky, Christian De Angelis, Christopher Carney, Bill Campbell, Laurin Conlin, Layne Norton, Fabricio Rossi
P56 Effect of a multi-ingredient preworkout supplement on cognitive function and perceptions of readiness to perform
MS Koozehchian, PB Collins, R Sowinski, T Grubic, R Dalton, A O’Connor, SY Shin, Y Peter Jung, BK Sanchez, A Coletta, M Cho, A Reyes, C Rasmussen, CP Earnest, PS Murano, M Greenwood, RB Kreider
PMCID: PMC5025820
24.  Promotional Tone in Reviews of Menopausal Hormone Therapy After the Women's Health Initiative: An Analysis of Published Articles 
PLoS Medicine  2011;8(3):e1000425.
Adriane Fugh-Berman and colleagues analyzed a selection of published opinion pieces on hormone therapy and show that there may be a connection between receiving industry funding for speaking, consulting, or research and the tone of such opinion pieces.
Even after the Women's Health Initiative (WHI) found that the risks of menopausal hormone therapy (hormone therapy) outweighed benefit for asymptomatic women, about half of gynecologists in the United States continued to believe that hormones benefited women's health. The pharmaceutical industry has supported publication of articles in medical journals for marketing purposes. It is unknown whether author relationships with industry affect promotional tone in articles on hormone therapy. The goal of this study was to determine whether promotional tone could be identified in narrative review articles regarding menopausal hormone therapy and whether articles identified as promotional were more likely to have been authored by those with conflicts of interest with manufacturers of menopausal hormone therapy.
Methods and Findings
We analyzed tone in opinion pieces on hormone therapy published in the four years after the estrogen-progestin arm of the WHI was stopped. First, we identified the ten authors with four or more MEDLINE-indexed reviews, editorials, comments, or letters on hormone replacement therapy or menopausal hormone therapy published between July 2002 and June 2006. Next, we conducted an additional search using the names of these authors to identify other relevant articles. Finally, after author names and affiliations were removed, 50 articles were evaluated by three readers for scientific accuracy and for tone. Scientific accuracy was assessed based on whether or not the findings of the WHI were accurately reported using two criteria: (1) Acknowledgment or lack of denial of the risk of breast cancer diagnosis associated with hormone therapy, and (2) acknowledgment that hormone therapy did not benefit cardiovascular disease endpoints. Determination of promotional tone was based on the assessment by each reader of whether the article appeared to promote hormone therapy. Analysis of inter-rater consistency found moderate agreement for scientific accuracy (κ = 0.57) and substantial agreement for promotional tone (κ = 0.65). After discussion, readers found 86% of the articles to be scientifically accurate and 64% to be promotional in tone. Themes that were common in articles considered promotional included attacks on the methodology of the WHI, arguments that clinical trial results should not guide treatment for individuals, and arguments that observational studies are as good as or better than randomized clinical trials for guiding clinical decisions. The promotional articles we identified also implied that the risks associated with hormone therapy have been exaggerated and that the benefits of hormone therapy have been or will be proven. Of the ten authors studied, eight were found to have declared payment for speaking or consulting on behalf of menopausal hormone manufacturers or for research support (seven of these eight were speakers or consultants). Thirty of 32 articles (90%) evaluated as promoting hormone therapy were authored by those with potential financial conflicts of interest, compared to 11 of 18 articles (61%) by those without such conflicts (p = 0.0025). Articles promoting the use of menopausal hormone therapy were 2.41 times (95% confidence interval 1.49–4.93) as likely to have been authored by authors with conflicts of interest as by authors without conflicts of interest. In articles from three authors with conflicts of interest some of the same text was repeated word-for-word in different articles.
There may be a connection between receiving industry funding for speaking, consulting, or research and the publication of promotional opinion pieces on menopausal hormone therapy.
Please see later in the article for the Editors' Summary
Editors' Summary
Over the past three decades, menopausal hormones have been heavily promoted for preventing disease in women. However, the Women's Health Initiative (WHI) study—which enrolled more than 26,000 women in the US and which was published in 2004—found that estrogen-progestin and estrogen-only formulations (often prescribed to women around the age of menopause) increased the risk of stroke, deep vein thrombosis, dementia, and incontinence. Furthermore, this study found that the estrogen-progestin therapy increased rates of breast cancer. In fact, the estrogen-progestin arm of the WHI study was stopped in 2002 due to harmful findings, and the estrogen-only arm was stopped in 2004, also because of harmful findings. In addition, the study also found that neither therapy reduced cardiovascular risk or markedly benefited health-related quality of life measures.
Despite these results, two years after the results of WHI study were published, a survey of over 700 practicing gynecologists—the specialists who prescribe the majority of menopausal hormone therapies—in the US found that almost half did not find the findings of the WHI study convincing and that 48% disagreed with the decision to stop the trial early. Furthermore, follow-up surveys found similar results.
Why Was This Study Done?
It is unclear why gynecologists and other physicians continue to prescribe menopausal hormone therapies despite the results of the WHI. Some academics argue that published industry-funded reviews and commentaries may be designed to convey specific, but subtle, marketing messages and several academic analyses have used internal industry documents disclosed in litigation cases. So this study was conducted to investigate whether hormone therapy–promoting tone could be identified in narrative review articles and if so, whether these articles were more likely to have been authored by people who had accepted funding from hormone manufacturers.
What Did the Researchers Do and Find?
The researchers conducted a comprehensive literature search that identified 340 relevant articles published between July 2002 and June 2006—the four years following the cessation of the estrogen-progestin arm of the women's health initiative study. Ten authors had published four to six articles, 47 authored two or three articles, and 371 authored one article each. The researchers focused on authors who had published four or more articles in the four-year period under study and, after author names and affiliations were removed, 50 articles were evaluated by three readers for scientific accuracy and for tone. After individually analyzing a batch of articles, the readers met to provide their initial assessments, to discuss them, and to reach consensus on tone and scientific accuracy. Then after the papers were evaluated, each author was identified and the researchers searched for authors' potential financial conflicts of interest, defined as publicly disclosed information that the authors had received payment for research, speaking, or consulting on behalf of a manufacturer of menopausal hormone therapy.
Common themes in the 50 articles included arguments that clinical trial results should not guide treatment for individuals and suggestions that the risks associated with hormone therapy have been exaggerated and that the benefits of hormone therapy have been or will be proven. Furthermore, of the ten authors studied, eight were found to have received payment for research, speaking or consulting on behalf of menopause hormone manufacturers, and 30 of 32 articles evaluated as promoting hormone therapy were authored by those with potential financial conflicts of interest. Articles promoting the use of menopausal hormone therapy were more than twice as likely to have been written by authors with conflicts of interest as by authors without conflicts of interest. Furthermore, Three authors who were identified as having financial conflicts of interest were authors on articles where sections of their previously published articles were repeated word-for-word without citation.
What Do These Findings Mean?
The findings of this study suggest that there may be a link between receiving industry funding for speaking, consulting, or research and the publication of apparently promotional opinion pieces on menopausal hormone therapy. Furthermore, such publications may encourage physicians to continue prescribing these therapies to women of menopausal age. Therefore, physicians and other health care providers should interpret the content of review articles with caution. In addition, medical journals should follow the International Committee of Medical Journal Editors Uniform Requirements for Manuscripts, which require that all authors submit signed statements of their participation in authorship and full disclosure of any conflicts of interest.
Additional Information
Please access these Web sites via the online version of this summary at
The US National Heart, Lung, and Blood Institute has more information on the Womens Health Initiative
The US National Institutes of Health provide more information about the effects of menopausal hormone replacement therapy
The Office of Women's Health, U.S. Department of Health and Human Services provides information on menopausal hormone therapy
The International Committee of Medical Journal Editors Uniform Requirements for Manuscripts presents Uniform Requirements for Manuscripts published in biomedical journals
The National Womens Health Network, a consumer advocacy group that takes no industry money, has factsheets and articles about menopausal hormone therapy
PharmedOut, a Georgetown University Medical Center project, has many resources on pharmaceutical marketing practices
PMCID: PMC3058057  PMID: 21423581
25.  The 40-Something randomized controlled trial to prevent weight gain in mid-age women 
BMC Public Health  2013;13:1007.
Obesity prevention is a major public health priority. Despite the health risks associated with weight gain, there has been a distinct lack of research into effective interventions to prevent, rather than treat, obesity particularly at high risk life stages such as menopause in women. This paper describes the rationale for and design of a 2-year randomized controlled trial (RCT) (the 40-Something Study) aimed at testing the feasibility and efficacy of a relatively low intensity intervention designed to achieve weight control in non-obese women about to enter the menopause transition.
Methods and design
The study is a parallel-group RCT consisting of 12 months of intervention (Phase 1) and 12 months of monitoring (Phase 2). Non-obese pre-menopausal healthy females 44–50 years of age were screened, stratified according to Body Mass Index (BMI) category (18.5-24.9 and 25–29.9 kg/m2) and randomly assigned to one of two groups: motivational interviewing (MI) intervention (n = 28), or a self-directed intervention (SDI) (control) (n = 26). The MI intervention consisted of five consultations with health professionals (four with a Dietitian and one with an Exercise Physiologist) who applied components of MI counselling to consultations with the women over a 12 month period. The SDI was developed as a control and these participants received print materials only. Outcome measures were collected at baseline, three, 12, 18 and 24 months and included weight (primary outcome), waist circumference, body composition, blood pressure, plasma markers of metabolic syndrome risk, dietary intake, physical activity and quality of life. Analysis of covariance will be used to investigate outcomes according to intervention type and duration (comparing baseline, 12 and 24 months).
The 40-Something study is the first RCT aimed at preventing menopausal weight gain in Australian women. Importantly, this paper describes the methods used to evaluate whether a relatively low intensity, health professional led intervention will achieve better weight control in pre-menopausal women than a self-directed intervention. The results will add to the scant body of literature on obesity prevention methods at an under-researched high-risk life stage, and inform the development of population-based interventions.
Trial registration
PMCID: PMC4016250  PMID: 24156558
Obesity prevention; Intervention; Menopause; Motivational interviewing

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