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1.  Intervening on spontaneous physical activity to prevent weight regain in older adults: Design of a randomized, clinical trial 
Contemporary clinical trials  2011;33(2):450-455.
There is a need to identify evidenced-based obesity treatments that are effective in maintaining lost weight. Weight loss results in reductions in energy expenditure, including spontaneous physical activity (SPA) which is defined as energy expenditure resulting primarily from unstructured mobility-related activities that occur during daily life. To date, there is little research, especially randomized, controlled trials, testing strategies that can be adopted and sustained to prevent declines in SPA that occur with weight loss. Self-monitoring is a successful behavioral strategy to facilitate behavior change, so a provocative question is whether monitoring SPA-related energy expenditure would override these reductions in SPA, and slow weight regain. This study is a randomized trial in older, obese men and women designed to test the hypothesis that adding a self-regulatory intervention (SRI), focused around self-monitoring of SPA, to a weight loss intervention will result in less weight and fat mass regain following weight loss than a comparable intervention that lacks this self-regulatory behavioral strategy. Participants (n=72) are randomized to a 5-month weight loss intervention with or without the addition of a behavioral component that includes an innovative approach to promoting increased SPA. Both groups then transition to self-selected diet and exercise behavior for a 5-month follow-up. Throughout the 10-month period, the SRI group is provided with an intervention designed to promote a SPA level that is equal to or greater than each individual's baseline SPA level, allowing us to isolate the effects of the SPA self-regulatory intervention component on weight and fat mass regain.
PMCID: PMC4318512  PMID: 22155531
Obesity; Weight loss maintenance; Self-monitoring; Self-regulation; Physical activity
2.  Positive and negative affect, depression, and cognitive processes in the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) Trial 
This study examined the relationship between positive and negative affect, depressive symptoms, and cognitive performance.
The sample consisted of 1,479 non-demented, postmenopausal women (mean age=67 years) at increased risk of breast cancer enrolled in the National Surgical Adjuvant Breast and Bowel Project’s Study of Tamoxifen and Raloxifene (STAR). At each annual visit, women completed a standardized neuropsychological battery and self-report measures of affect and depression. Data from 3 visits were used in linear mixed models for repeated measures using likelihood ratio tests. Separate analyses were performed to relate positive/negative affect and depression to each cognitive measure.
Higher positive affect was associated with better letter fluency (p=0.006) and category fluency (p<0.0001). Higher negative affect was associated with worse global cognitive function (p<0.0001), verbal memory (CVLT List B; p=0.002), and spatial ability (p<0.0001). Depressive symptoms were negatively associated with verbal knowledge (p=0.004), figural memory (p<0.0001), and verbal memory (p’s≤0.0001).
Findings are consistent with some prior research demonstrating a link between positive affect and increased verbal fluency and between depressive symptoms and decreased memory. The most novel finding shows that negative affect is related to decreased global cognition and visuospatial ability. Overall, this research in a large, longitudinal sample supports the notion that positive affect is related to increases and negative affect to decreases in performance on distinct cognitive measures.
PMCID: PMC3815441  PMID: 23237718
positive affect; negative affect; depression; cognition; women’s health
3.  Physical Activity and Physical Function in Older Adults With Knee Osteoarthritis 
To assess correlates of physical activity, and to examine the relationship between physical activity and physical functioning, in 160 older (66 ± 6 years old), overweight/obese (mean body mass index = 33.5 ± 3.8 kg/m2), sedentary (less than 30 mins of activity, 3 days a week) individuals with knee osteoarthritis.
Physical activity was measured with accelerometers and by self-report. Physical function was assessed by 6-min walk distance, knee strength, and the Short Physical Performance Battery. Pain and perceived function were measured by questionnaires. Pearson correlations and general linear models were used to analyze the relationships.
The mean number of steps taken per day was 6209 and the average PAEE was 237 ± 124 kcal/day. Participants engaged in 131 ± 39 minutes of light physical activity (LPA) and 10.6 ± 8.9 minutes of moderate-vigorous physical activity (MPA/VPA). Total steps/day, PAEE, and minutes of MPA/VPA were all negatively correlated with age. The 6-min walk distance and lower extremity function were better in those who had higher total steps/day, higher PAEE, higher minutes of MPA/VPA, and a higher PASE score.
This study demonstrates that a population who has higher levels of spontaneous activity have better overall physical function than those who engage in less activity.
PMCID: PMC4142418  PMID: 23307503
exercise; aging; overweight; obese
4.  Telephone interview for cognitive status (TICS) screening for clinical trials of physical activity and cognitive training: the seniors health and activity research program pilot (SHARP-P) study† 
International journal of geriatric psychiatry  2011;26(2):10.1002/gps.2503.
To examine the performance of the Telephone Interview for Cognitive Status (TICS) for identifying participants appropriate for trials of physical activity and cognitive training interventions.
Volunteers (N = 343), ages 70–85 years, who were being recruited for a pilot clinical trial on approaches to prevent cognitive decline, were administered TICS and required to score ≥31 prior to an invitation to attend clinic-based assessments. The frequencies of contraindications for physical activity and cognitive training interventions were tallied for individuals grouped by TICS scores. Relationships between TICS scores and other measures of cognitive function were described by scatterplots and correlation coefficients.
Eligibility criteria to identify candidates who were appropriate candidates for the trial interventions excluded 51.7% of the volunteers with TICS<31. TICS scores above this range were not strongly related to cognition or attendance at screening visits, however overall enrollment yields were approximately half for participants with TICS = 31 versus TICS = 41, and increased in a graded fashion throughout the range of scores.
Use of TICS to define eligibility criteria in trials of physical activity and cognitive training interventions may not be worthwhile in that many individuals with low scores would already be eliminated by intervention-specific criteria and the relationship of TICS with clinic-based tests of cognitive function among appropriate candidates for these interventions may be weak. TICS may be most useful in these trials to identify candidates for oversampling in order to obtain a balanced cohort of participants at risk for cognitive decline.
PMCID: PMC3832189  PMID: 21229597
clinical trial design; cognitive interventions; eligibility criteria
5.  Validation of a cognitive assessment battery administered by telephone 
While the gold standard method of cognitive assessment is a face-to-face administration, telephone-based assessments offer several advantages if they demonstrate reliability and validity.
Observational study; 110 participants randomly assigned to receive two administrations of the same cognitive test battery 6 months apart in one of four combinations (1st administration/2nd administration): telephone/telephone; telephone/face-to-face; face-to-face/telephone; or face-to-face/face-to-face.
Academic medical center
110 non-demented women between the ages of 65 and 90 years.
The battery included tests of attention, verbal learning and memory, verbal fluency, executive function, working memory and global cognitive functioning plus self-report measures of perceived memory problems, depressive symptoms, sleep disturbance and health-related quality of life. Test-retest reliability, concurrent validity, relative bias associated with telephone administration, and change scores were evaluated.
There were no statistically significant differences in scores on any of the cognitive tests or questionnaires between randomly assigned modes of administration at baseline indicating equivalence across modes. There was no significant bias for tests or questionnaires administered by telephone (ps>0.01). Nor was there a difference in mean change scores between administration modes except for the Category Fluency (p = 0.01) and the California Verbal Learning Test long delay-free recall (p < 0.01). Mean test-retest coefficients for the battery were not significantly different across groups though individual test-retest correlation coefficients were generally higher within mode than across mode.
Telephone administration of cognitive tests and questionnaires to older women is both reliable and valid. Use of telephone batteries can substantially reduce the economic cost and burden of cognitive assessments and increase enrollment, retention and data completeness thereby improving study validity.
PMCID: PMC3448122  PMID: 22985137
cognition; assessment; telephone; validation; tests
6.  Does high weight loss in older adults with knee osteoarthritis affect bone-on-bone joint loads and muscle forces during walking? 
The aim of this study was to examine the effects of high weight loss on knee joint loads during walking in participants with knee OA.
Data were obtained from a subset of participants enrolled in the Arthritis, Diet, and Activity Promotion Trial (ADAPT). Complete baseline and 18 month follow-up data were obtained on 76 sedentary, overweight or obese older adults with radiographic knee OA. Three-dimensional gait analysis was used to calculate knee joint forces and moments. The cohort was divided into high (> 5%), low (< 5%), and no (0% or gain) weight loss groups.
From baseline body weight, the high weight loss group lost an average of 10.2%, the low weight loss group lost an average of 2.7%, and the no weight loss group gained 1.5%. Adjusted 18 month outcome data revealed lower maximum knee compressive forces with greater weight loss (p = 0.05). The difference in compressive forces between the high weight loss and no weight loss groups was due primarily to lower hamstring forces (p = 0.04). Quadriceps forces were similar between the groups at 18 month follow-up. There was no difference between the groups in 18-month joint space width or Kellgren-Lawrence scores.
These results suggest that a 10% weight loss in an overweight and obese osteoarthritic population elicits positive changes in the mechanical pathway to knee osteoarthritis by having lower knee joint compressive loads during walking compared to low and no weight loss groups. The difference in compressive forces was due, in large part, to reductions in hamstring co-contraction during the initial portion of the stance phase.
PMCID: PMC3444807  PMID: 21134477
biomechanics; gait; knee joint loads; musculoskeletal modeling; knee OA
7.  Long Term Effects of Conjugated Equine Estrogens Therapies on Domain-Specific Cognitive Function: Results from the Women's Health Initiative Study of Cognitive Aging (WHISCA) Extension 
Conjugated equine estrogen (CEE) therapies when initiated among older women have been shown to produce small decrements in global cognitive function. We are interested whether these persist after cessation and extend to specific cognitive domains.
Randomized controlled clinical trial
Fourteen clinical centers of the Women's Health Initiative
2,304 women aged 65-80 years and free of probable dementia at enrollment
0.625 mg/day of CEE, with or without medroxyprogesterone acetate (MPA, 10 mg/day), and matching placebos
Annual administrations of a battery of cognitive tests during and following the trial
General linear models were used to compare on-trial and post-trial mean standardized test scores between treatment groups, with adjustment for baseline risk factors for cognitive impairment.
Assignment to CEE-based therapies was associated with small mean relative decrements in global and several domain-specific cognitive functions on-trial, which largely persisted through up to 4 years post-trial. The strongest statistical evidence was for global cognitive function: 0.07 standard deviation decrements both on-trial (p=0.007) and post-trial (p=0.01). Among domain specific scores, the mean relative decrements were slightly smaller, were less significant, and tended to be larger for CEE-alone therapy.
CEE-based therapies, when initiated after age 65 years, produce a small broad-based decrement in cognitive function that persists after their use is stopped. The differences in cognitive function however are small and would not be detectable or have clinical significance for an individual woman. Differences in effects among cognitive domains suggest that more than one mechanism may be involved.
PMCID: PMC2917208  PMID: 20649689
Postmenopausal hormone therapy; Cognitive function; Women's health
8.  Subtypes of Mild Cognitive Impairment in Older Postmenopausal Women: The Women’s Health Initiative Memory Study 
Mild cognitive impairment (MCI) is a transitional state between normal cognitive functioning and dementia. A proposed MCI typology1 classifies individuals by the type and extent of cognitive impairment, yet few studies have characterized or compared these subtypes. 447 women 65 years of age and older from the Women’s Health Initiative Memory Study2 were classified into the four MCI subgroups and a ‘no impairment’ group and compared on clinical, sociodemographic, and health variables.
82.1% of participants had a cognitive deficit in at least one domain with most (74.3%) having deficits in multiple cognitive domains. Only 4.3% had an isolated memory deficit, while 21.3% had an isolated non-memory deficit. Of the 112 women who met all MCI criteria examined, the most common subtype was amnestic multi-domain MCI (42.8%) followed by non-amnestic multiple domain MCI (26.7%), non-amnestic single domain (24.1%) and amnestic single domain MCI (6.3%). Subtypes were similar with respect to education, health status, smoking, depression and pre- and on-study use of hormone therapy.
Despite the attention it receives in the literature amnestic MCI is the least common type highlighting the importance of identifying and characterizing other non-amnestic and multi-domain subtypes. Further research is needed on the epidemiology of MCI subtypes, clinical and biological differences between them and rates for conversion to dementia.
PMCID: PMC2929315  PMID: 20473134
MCI; women; WHIMS; postmenopausal; cognition; dementia; hormone therapy
9.  Designing clinical trials for assessing the effects of cognitive training and physical activity interventions on cognitive outcomes: The Seniors Health and Activity Research Program Pilot (SHARP-P) Study, a randomized controlled trial 
BMC Geriatrics  2011;11:27.
The efficacy of non-pharmacological intervention approaches such as physical activity, strength, and cognitive training for improving brain health has not been established. Before definitive trials are mounted, important design questions on participation/adherence, training and interventions effects must be answered to more fully inform a full-scale trial.
SHARP-P was a single-blinded randomized controlled pilot trial of a 4-month physical activity training intervention (PA) and/or cognitive training intervention (CT) in a 2 × 2 factorial design with a health education control condition in 73 community-dwelling persons, aged 70-85 years, who were at risk for cognitive decline but did not have mild cognitive impairment.
Intervention attendance rates were higher in the CT and PACT groups: CT: 96%, PA: 76%, PACT: 90% (p=0.004), the interventions produced marked changes in cognitive and physical performance measures (p≤0.05), and retention rates exceeded 90%. There were no statistically significant differences in 4-month changes in composite scores of cognitive, executive, and episodic memory function among arms. Four-month improvements in the composite measure increased with age among participants assigned to physical activity training but decreased with age for other participants (intervention*age interaction p = 0.01). Depending on the choice of outcome, two-armed full-scale trials may require fewer than 1,000 participants (continuous outcome) or 2,000 participants (categorical outcome).
Good levels of participation, adherence, and retention appear to be achievable for participants through age 85 years. Care should be taken to ensure that an attention control condition does not attenuate intervention effects. Depending on the choice of outcome measures, the necessary sample sizes to conduct four-year trials appear to be feasible.
Trial Registration Identifier: NCT00688155
PMCID: PMC3126708  PMID: 21615936
10.  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
11.  Psychiatric Disorders and Cognitive Dysfunction Among Older, Postmenopausal Women: Results From the Women’s Health Initiative Memory Study 
To estimate the frequency of depressive symptoms and selected psychiatric disorders in the Women’s Health Initiative Memory Study (WHIMS) cohort and related them to cognitive syndromes.
WHIMS was a randomized, double-blinded, placebo-controlled prevention clinical trial examining whether opposed and unopposed hormone therapy reduced the risk of dementia in healthy postmenopausal women. Participants scoring below a designated cutpoint on a cognitive screener received a comprehensive neuropsychiatric workup and adjudicated outcome of no cognitive impairment, mild cognitive impairment, or probable dementia.
Seven thousand four hundred seventy-nine WHIMS participants between age 65 and 79 years and free of dementia at the time of enrollment in WHIMS. Five hundred twenty-one unique participants contributed complete data required for these analyses.
Depressive symptoms were measured with the 15-item Geriatric Depression Scale and the presence of selected psychiatric disorders (major depression, generalized anxiety, and panic and alcohol abuse) was made using the PRIME-MD.
The 18% of women had at least one psychiatric disorder with depression being the most common (16%) followed by general anxiety or panic (6%) and alcohol abuse (1%). Depression and the presence of a psychiatric disorder were associated with impaired cognitive status. Participants having a psychiatric disorder were more than twice as likely to be diagnosed with cognitive impairment as those with no psychiatric disorder (odds ratio = 2.06, 95% confidence interval = 1.17–3.60). Older age, white race, and diabetes were also associated with cognitive impairment.
The frequency of a psychiatric disorder is associated with poorer cognitive functioning among older women enrolled in WHIMS. That approximately one in five women had a probable psychiatric disorder, most typically depression, highlights the need for greater detection and treatment efforts in this population.
PMCID: PMC2939041  PMID: 20104074
Psychiatric disorders; cognition; MCI; risk of dementia; comorbidity
12.  Correlates of Sexual Satisfaction Among Sexually Active Postmenopausal Women in the Women’s Health Initiative-Observational Study 
Journal of General Internal Medicine  2008;23(12):2000-2009.
Satisfaction with sexual activity is important for health-related quality of life, but little is known about the sexual health of postmenopausal women.
Describe factors associated with sexual satisfaction among sexually active postmenopausal women.
Cross-sectional analysis.
All members of the Women’s Health Initiative-Observational Study (WHI-OS), ages 50–79, excluding women who did not respond to the sexual satisfaction question or reported no partnered sexual activity in the past year (N = 46,525).
Primary outcome: dichotomous response to the question, “How satisfied are you with your sexual activity (satisfied versus unsatisfied)?” Covariates included sociodemographic factors, measures of physical and mental health, and gynecological variables, medications, and health behaviors related to female sexual health.
Of the cohort, 52% reported sexual activity with a partner in the past year, and 96% of these answered the sexual satisfaction question. Nonmodifiable factors associated with sexual dissatisfaction included age, identification with certain racial or ethnic groups, marital status, parity, and smoking history. Potentially modifiable factors included lower mental health status and use of SSRIs. The final model yielded a c-statistic of 0.613, reflecting only a modest ability to discriminate between the sexually satisfied and dissatisfied.
Among postmenopausal women, the variables selected for examination yielded modest ability to discriminate between sexually satisfied and dissatisfied participants. Further study is necessary to better describe the cofactors associated with sexual satisfaction in postmenopausal women.
PMCID: PMC2596524  PMID: 18839256
sexual dysfunction; physiological; sexual dysfunctions; psychological; women; menopause; postmenopause; cohort studies
13.  Effect of an exercise and dietary intervention on serum biomarkers in overweight and obese adults with osteoarthritis of the knee1 
To determine the effects of exercise and weight loss interventions on serum levels of four biomarkers and to examine if changes in biomarker levels correlate with clinical outcome measures in obese and overweight adults with knee OA.
Serum was obtained at baseline, 6- and 18-months from 193 participants in ADAPT (Arthritis, Diet and Activity Promotion Trial). This was a single-blind 18-month trial with subjects randomized to four groups: healthy-lifestyle (HL), diet (D), exercise (E) and diet plus exercise (D+E). Serum levels of cartilage oligomeric protein (COMP), hyaluronan (HA), antigenic keratan sulfate (AgKS) and transforming growth factor-β1 (TGF-β1) were measured by ELISA.
At baseline there were no significant differences in biomarker levels between intervention groups. When results for all the intervention groups were combined, the levels of HA were found to be negatively correlated with medial joint space width and positively correlated with Kellgren-Lawrence scores (K-L scores) while TGF-β1 levels negatively correlated with K-L scores. When biomarker levels measured at 6 and 18-months were adjusted for baseline values, age, gender, and body mass index (BMI), weak but significant differences between intervention groups were present for mean levels of COMP and TGF-β1. Furthermore, AgKS levels averaged over all groups tended to decrease over time. There were no significant associations of baseline biomarkers and the follow-up outcomes. Weak associations were noted between change in the biomarkers at 18-months and change in outcome measures that included change in weight with AgKS and COMP and change in WOMAC pain with AgKS.
Overall, the exercise and dietary interventions did not show a consistent effect on levels of potential OA biomarkers. The four biomarkers showed differences in correlations with outcome measures suggesting they may measure different aspects of disease activity in OA. The strongest correlations were between serum HA and radiographic measures of OA at baseline.
PMCID: PMC2610445  PMID: 18359648
biomarkers; osteoarthritis; clinical trials; hyaluronan; COMP; TGF-β
14.  The Intensive Diet and Exercise for Arthritis (IDEA) trial: design and rationale 
Obesity is the most modifiable risk factor, and dietary induced weight loss potentially the best nonpharmacologic intervention to prevent or to slow osteoarthritis (OA) disease progression. We are currently conducting a study to test the hypothesis that intensive weight loss will reduce inflammation and joint loads sufficiently to alter disease progression, either with or without exercise. This article describes the intervention, the empirical evidence to support it, and test-retest reliability data.
This is a prospective, single-blind, randomized controlled trial. The study population consists of 450 overweight and obese (BMI = 27–40.5 kg/m2) older (age ≥ 55 yrs) adults with tibiofemoral osteoarthritis. Participants are randomized to one of three 18-month interventions: intensive dietary restriction-plus-exercise; exercise-only; or intensive dietary restriction-only. The primary aims are to compare the effects of these interventions on inflammatory biomarkers and knee joint loads. Secondary aims will examine the effects of these interventions on function, pain, and mobility; the dose response to weight loss on disease progression; if inflammatory biomarkers and knee joint loads are mediators of the interventions; and the association between quadriceps strength and disease progression.
Test-retest reliability results indicated that the ICCs for knee joint load variables were excellent, ranging from 0.86 – 0.98. Knee flexion/extension moments were most affected by BMI, with lower reliability with the highest tertile of BMI. The reliability of the semi-quantitative scoring of the knee joint using MRI exceeded previously reported results, ranging from a low of 0.66 for synovitis to a high of 0.99 for bone marrow lesion size.
The IDEA trial has the potential to enhance our understanding of the OA disease process, refine weight loss and exercise recommendations in this prevalent disease, and reduce the burden of disability.
Trial Registration
PMCID: PMC2729726  PMID: 19638215

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