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1.  Does physical activity counselling enhance the effects of a pedometer-based intervention over the long-term: 12-month findings from the Walking for Wellbeing in the west study 
BMC Public Health  2012;12:206.
Background
Pedometers provide a simple, cost effective means of motivating individuals to increase walking yet few studies have considered if short term changes in walking behaviour can be maintained in the long-term. The role of physical activity consultations in such interventions is unclear. The purpose of this study was to assess the sustainability of pedometer-based interventions and empirically examine the role of physical activity consultations using long-term results of a community-based walking study.
Methods
79 low active Scottish men and women (63 women and 16 men) from the Walking for Wellbeing in the West intervention study were randomly assigned to receive either: Group 1; pedometer-based walking programme plus physical activity consultations or Group 2; pedometer-based walking programme and minimal advice. Step counts (Omron HJ-109E Step-O-Meter pedometer), 7 day recall of physical activity (IPAQ long), mood (PANAS) and quality of life (EuroQol EQ-5D) were assessed pre-intervention and 12, 24 and 48 weeks after receiving the intervention. Body mass, body mass index and waist and hip circumference were assessed pre-intervention and 12 and 24 weeks after receiving the intervention. Analyses were performed on an intention to treat basis (baseline value carried forward for missing data) using mixed-factorial ANOVAs and follow-up t-tests.
Results
A significant main effect of time (p < 0.001) was found for step-counts attributable to significant increases in steps/day between: pre-intervention (M = 6941, SD = 3047) and 12 weeks (M = 9327, SD = 4136), t(78) = - 6.52, p < 0.001, d = 0.66; pre-intervention and 24 weeks (M = 8804, SD = 4145), t(78) = - 4.82, p < 0.001, d = 0.52; and pre-intervention and 48 weeks (M = 8450, SD = 3855), t(78) = - 4.15, p < 0.001, d = 0.44. Significant effects were found for several variables of self-reported physical activity, mood and quality of life and are discussed. No other significant effects in health related outcomes were found.
Conclusion
Both interventions successfully increased and maintained step counts over 12 months. Physical activity consultations may encourage individuals to be active in other ways beyond walking and to reduce sitting time.
Trial Registration Number
Current Controlled Trials Ltd ISRCTN88907382
doi:10.1186/1471-2458-12-206
PMCID: PMC3349531  PMID: 22429600
2.  Increasing physical activity in postpartum multiethnic women in Hawaii: results from a pilot study 
BMC Women's Health  2009;9:4.
Background
Mothers of an infant are much less likely to exercise regularly compared to other women. This study tested the efficacy of a brief tailored intervention to increase physical activity (PA) in women 3–12 months after childbirth. The study used a pretest-posttest design. Sedentary women (n = 20) were recruited from a parenting organization. Half the participants were ethnic minorities, mean age was 33 ± 3.8, infants' mean age was 6.9 ± 2.4 months, 50% were primiparas, and mean body mass index was 23.6 ± 4.2.
Methods
The two-month intervention included telephone counseling, pedometers, referral to community PA resources, social support, email advice on PA/pedometer goals, and newsletters.
The primary outcome of the study was minutes per week of moderate and vigorous leisure-time physical activity measured by the Godin physical activity instrument.
Results
All women (100%) returned for post-test measures; thus, paired t-tests were used for pre-post increase in minutes of moderate and vigorous leisure-time physical activity and comparisons of moderate and vigorous leisure-time physical activity increases among ethnic groups. At baseline participants' reported a mean of 3 ± 13.4 minutes per week moderate and vigorous leisure-time physical activity. At post-test this significantly increased to 85.5 ± 76.4 minutes per week of moderate and vigorous leisure-time physical activity (p < .001, Cohen's d = 2.2; effect size r = 0.7). There were no differences in pre to post increases in minutes of moderate and vigorous leisure-time physical activity among races.
Conclusion
A telephone/email intervention tailored to meet the needs of postpartum women was effective in increasing physical activity levels. However, randomized trials comparing tailored telephone and email interventions to standard care and including long-term follow-up to determine maintenance of physical activity are warranted.
doi:10.1186/1472-6874-9-4
PMCID: PMC2662815  PMID: 19254387
3.  The effect of a pedometer-based community walking intervention "Walking for Wellbeing in the West" on physical activity levels and health outcomes: a 12-week randomized controlled trial 
Background
Recent systematic reviews have suggested that pedometers may be effective motivational tools to promote walking. However, studies tend to be of a relatively short duration, with small clinical based samples. Further research is required to demonstrate their effectiveness in adequately powered, community based studies.
Objective
Using a randomized controlled trial design, this study assessed the impact of a 12-week graduated pedometer-based walking intervention on daily step-counts, self-reported physical activity and health outcomes in a Scottish community sample not meeting current physical activity recommendations.
Method
Sixty-three women and 16 men (49.2 years ± 8.8) were randomly assigned to either an intervention (physical activity consultation and 12-week pedometer-based walking program) or control (no action) group. Measures for step-counts, 7-day physical activity recall, affect, quality of life (n = 79), body mass, BMI, % body fat, waist and hip circumference (n = 76), systolic/diastolic blood pressure, total cholesterol and HDL cholesterol (n = 66) were taken at baseline and week 12. Analyses were performed on an intention to treat basis using 2-way mixed factorial analyses of variance for parametric data and Mann Whitney and Wilcoxon tests for non-parametric data.
Results
Significant increases were found in the intervention group for step-counts (p < .001), time spent in leisure walking (p = .02) and positive affect (p = .027). Significant decreases were found in this group for time spent in weekday (p = .003), weekend (p = .001) and total sitting (p = .001) with no corresponding changes in the control group. No significant changes in any other health outcomes were found in either group. In comparison with the control group at week 12, the intervention group reported a significantly greater number of minutes spent in leisure time (p = .008), occupational (p = .045) and total walking (p = .03), and significantly fewer minutes in time spent in weekend (p = .003) and total sitting (p = .022).
Conclusion
A pedometer-based walking program, incorporating a physical activity consultation, is effective in promoting walking and improving positive affect over 12 weeks in community based individuals. The discussion examines possible explanations for the lack of significant changes in health outcomes. Continued follow-up of this study will examine adherence to the intervention and possible resulting effects on health outcomes.
doi:10.1186/1479-5868-5-44
PMCID: PMC2546435  PMID: 18775062
4.  Primary Prevention of Gestational Diabetes Mellitus and Large-for-Gestational-Age Newborns by Lifestyle Counseling: A Cluster-Randomized Controlled Trial 
PLoS Medicine  2011;8(5):e1001036.
In a cluster-randomized trial, Riitta Luoto and colleagues find that counseling on diet and activity can reduce the birthweight of babies born to women at risk of developing gestational diabetes mellitus (GDM), but fail to find an effect on GDM.
Background
Our objective was to examine whether gestational diabetes mellitus (GDM) or newborns' high birthweight can be prevented by lifestyle counseling in pregnant women at high risk of GDM.
Method and Findings
We conducted a cluster-randomized trial, the NELLI study, in 14 municipalities in Finland, where 2,271 women were screened by oral glucose tolerance test (OGTT) at 8–12 wk gestation. Euglycemic (n = 399) women with at least one GDM risk factor (body mass index [BMI] ≥25 kg/m2, glucose intolerance or newborn's macrosomia (≥4,500 g) in any earlier pregnancy, family history of diabetes, age ≥40 y) were included. The intervention included individual intensified counseling on physical activity and diet and weight gain at five antenatal visits. Primary outcomes were incidence of GDM as assessed by OGTT (maternal outcome) and newborns' birthweight adjusted for gestational age (neonatal outcome). Secondary outcomes were maternal weight gain and the need for insulin treatment during pregnancy. Adherence to the intervention was evaluated on the basis of changes in physical activity (weekly metabolic equivalent task (MET) minutes) and diet (intake of total fat, saturated and polyunsaturated fatty acids, saccharose, and fiber). Multilevel analyses took into account cluster, maternity clinic, and nurse level influences in addition to age, education, parity, and prepregnancy BMI. 15.8% (34/216) of women in the intervention group and 12.4% (22/179) in the usual care group developed GDM (absolute effect size 1.36, 95% confidence interval [CI] 0.71–2.62, p = 0.36). Neonatal birthweight was lower in the intervention than in the usual care group (absolute effect size −133 g, 95% CI −231 to −35, p = 0.008) as was proportion of large-for-gestational-age (LGA) newborns (26/216, 12.1% versus 34/179, 19.7%, p = 0.042). Women in the intervention group increased their intake of dietary fiber (adjusted coefficient 1.83, 95% CI 0.30–3.25, p = 0.023) and polyunsaturated fatty acids (adjusted coefficient 0.37, 95% CI 0.16–0.57, p<0.001), decreased their intake of saturated fatty acids (adjusted coefficient −0.63, 95% CI −1.12 to −0.15, p = 0.01) and intake of saccharose (adjusted coefficient −0.83, 95% CI −1.55 to −0.11, p  =  0.023), and had a tendency to a smaller decrease in MET minutes/week for at least moderate intensity activity (adjusted coefficient 91, 95% CI −37 to 219, p = 0.17) than women in the usual care group. In subgroup analysis, adherent women in the intervention group (n = 55/229) had decreased risk of GDM (27.3% versus 33.0%, p = 0.43) and LGA newborns (7.3% versus 19.5%, p = 0.03) compared to women in the usual care group.
Conclusions
The intervention was effective in controlling birthweight of the newborns, but failed to have an effect on maternal GDM.
Trial registration
Current Controlled Trials ISRCTN33885819
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Gestational diabetes mellitus (GDM) is diabetes that is first diagnosed during pregnancy. Like other types of diabetes, it is characterized by high levels of sugar (glucose) in the blood. Blood-sugar levels are normally controlled by insulin, a hormone that the pancreas releases when blood-sugar levels rise after meals. Hormonal changes during pregnancy and the baby's growth demands increase a pregnant woman's insulin needs and, if her pancreas cannot make enough insulin, GDM develops. Risk factors for GDM, which occurs in 2%–14% of pregnant women, include a high body-mass index (a measure of body fat), excessive weight gain or low physical activity during pregnancy, high dietary intake of polyunsaturated fats, glucose intolerance (an indicator of diabetes) or the birth of a large baby in a previous pregnancy, and a family history of diabetes. GDM is associated with an increased rate of cesarean sections, induced deliveries, birth complications, and large-for-gestational-age (LGA) babies (gestation is the time during which the baby develops within the mother). GDM, which can often be controlled by diet and exercise, usually disappears after pregnancy but increases a woman's subsequent risk of developing diabetes.
Why Was This Study Done?
Although lifestyle changes can be used to control GDM, it is not known whether similar changes can prevent GDM developing (“primary prevention”). In this cluster-randomized controlled trial, the researchers investigate whether individual intensified counseling on physical activity, diet, and weight gain integrated into routine maternity care visits can prevent the development of GDM and the occurrence of LGA babies among newborns. In a cluster-randomized controlled trial, groups of patients rather than individual patients are randomly assigned to receive alternative interventions, and the outcomes in different “clusters” are compared. In this trial, each cluster is a municipality in the Pirkanmaa region of Finland.
What Did the Researchers Do and Find?
The researchers enrolled 399 women, each of whom had a normal blood glucose level at 8–12 weeks gestation but at least one risk factor for GDM. Women in the intervention municipalities received intensified counseling on physical activity at 8–12 weeks' gestation, dietary counseling at 16–18 weeks' gestation, and further physical activity and dietary counseling at each subsequent antenatal visits. Women in the control municipalities received some dietary but little physical activity counseling as part of their usual care. 23.3% and 20.2% of women in the intervention and usual care groups, respectively, developed GDM, a nonstatistically significant difference (that is, a difference that could have occurred by chance). However, the average birthweight and the proportion of LGA babies were both significantly lower in the intervention group than in the usual care group. Food frequency questionnaires completed by the women indicated that, on average, those in the intervention group increased their intake of dietary fiber and polyunsaturated fatty acids and decreased their intake of saturated fatty acids and sucrose as instructed during counseling, The amount of moderate physical activity also tended to decrease less as pregnancy proceeded in the intervention group than in usual care group. Finally, compared to the usual care group, significantly fewer of the 24% of women in the intervention group who actually met dietary and physical activity targets (“adherent” women) developed GDM.
What Do These Findings Mean?
These findings indicate that intensified counseling on diet and physical activity is effective in controlling the birthweight of babies born to women at risk of developing GDM and encourages at least some of them to alter their lifestyle. However, the findings fail to show that the intervention reduces the risk of GDM because of the limited power of the study. The power of a study—the probability that it will achieve a statistically significant result—depends on the study's size and on the likely effect size of the intervention. Before starting this study, the researchers calculated that they would need 420 participants to see a statistically significant difference between the groups if their intervention reduced GDM incidence by 40%. This estimated effect size was probably optimistic and therefore the study lacked power. Nevertheless, the analyses performed among adherent women suggest that lifestyle changes might be a way to prevent GDM and so larger studies should now be undertaken to test this potential primary prevention intervention.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001036.
The US National Institute of Diabetes and Digestive and Kidney Diseases provides information for patients on diabetes and on gestational diabetes (in English and Spanish)
The UK National Health Service Choices website also provides information for patients on diabetes and on gestational diabetes, including links to other useful resources
The MedlinePlus Encyclopedia has pages on diabetes and on gestational diabetes; MedlinePlus provides links to additional resources on diabetes and on gestational diabetes (in English and Spanish)
More information on this trial of primary prevention of GDM is available
doi:10.1371/journal.pmed.1001036
PMCID: PMC3096610  PMID: 21610860
5.  PACE-UP (Pedometer and consultation evaluation - UP) – a pedometer-based walking intervention with and without practice nurse support in primary care patients aged 45–75 years: study protocol for a randomised controlled trial 
Trials  2013;14:418.
Background
Most adults do not achieve the 150 minutes weekly of at least moderate intensity activity recommended for health. Adults’ most common physical activity (PA) is walking, light intensity if strolling, moderate if brisker. Pedometers can increase walking; however, most trials have been short-term, have combined pedometer and support effects, and have not reported PA intensity. This trial will investigate whether pedometers, with or without nurse support, can help less active 45–75 year olds to increase their PA over 12 months.
Methods/design
Design: Primary care-based 3-arm randomized controlled trial with 12-month follow-up and health economic and qualitative evaluations.
Participants: Less active 45–75 year olds (n = 993) will be recruited by post from six South West London general practices, maximum of two per household and households randomised into three groups. Step-count and time spent at different PA intensities will be assessed for 7 days at baseline, 3 and 12 months by accelerometer. Questionnaires and anthropometric assessments will be completed.
Intervention: The pedometer-alone group will be posted a pedometer (Yamax Digi-Walker SW-200), handbook and diary detailing a 12-week pedometer-based walking programme, using targets from their baseline assessment. The pedometer-plus-support group will additionally receive three practice nurse PA consultations. The handbook, diary and consultations include behaviour change techniques (e.g., self-monitoring, goal-setting, relapse prevention planning). The control group will receive usual care.
Outcomes: Changes in average daily step-count (primary outcome), time spent sedentary and in at least moderate intensity PA weekly at 12 months, measured by accelerometry. Other outcomes include change in body mass index, body fat, self-reported PA, quality of life, mood and adverse events. Cost-effectiveness will be assessed by the incremental cost of the intervention to the National Health Service and incremental cost per change in step-count and per quality adjusted life year. Qualitative evaluations will explore reasons for trial non-participation and the interventions’ acceptability.
Discussion
The PACE-UP trial will determine the effectiveness and cost-effectiveness of a pedometer-based walking intervention delivered by post or practice nurse to less active primary care patients aged 45–75 years old. Approaches to minimise bias and challenges anticipated in delivery will be discussed.
Trial registration
ISRCTN98538934
doi:10.1186/1745-6215-14-418
PMCID: PMC4235020  PMID: 24304838
Accelerometers; Behaviour change techniques; Cognitive behavioural; Middle-aged adults; Older people; Pedometers; Physical activity; Postal; Practice nurse; Primary care; Walking intervention
6.  Limiting postpartum weight retention through early antenatal intervention: the HeLP-her randomised controlled trial 
Background
Pregnancy is a recognised high risk period for excessive weight gain, contributing to postpartum weight retention and obesity development long-term. We aimed to reduce postpartum weight retention following a low-intensity, self-management intervention integrated with routine antenatal care during pregnancy.
Methods
228 women at increased risk of gestational diabetes, <15 weeks gestation were randomised to intervention (4 self-management sessions) or control (generic health information). Outcomes, collected at baseline and 6 weeks postpartum, included anthropometrics (weight and height), physical activity (pedometer) and questionnaires (health behaviours).
Results
Mean age (32.3 ± 4.7 and 31.7 ± 4.4 years) and body mass index (30.4 ± 5.6 and 30.3 ± 5.9 kg/m2) were similar between intervention and control groups, respectively at baseline. By 6 weeks postpartum, weight change in the control group was significantly higher than the intervention group with a between group difference of 1.45 ± 5.1 kg (95% CI: −2.86,-0.02; p < 0.05) overall, with a greater difference in weight found in overweight, but not obese women. Intervention group allocation, higher baseline BMI, GDM diagnosis, country of birth and higher age were all independent predictors of lower weight retention at 6 weeks postpartum on multivariable linear regression. Other factors related to weight including physical activity, did not differ between groups.
Conclusions
A low intensity intervention, integrated with standard antenatal care is effective in limiting postpartum weight retention. Implementation research is now required for scale-up to optimise antenatal health care.
Trial registration
Australian New Zealand Clinical Trial Registry Number: ACTRN12608000233325. Registered 7/5/2008.
doi:10.1186/s12966-014-0134-8
PMCID: PMC4221718  PMID: 25358909
Postpartum weight retention; Gestational weight gain; Pregnancy; Lifestyle intervention; Self-management; Gestational diabetes
7.  Monthly Variation in Physical Activity Levels in Post-Menopausal Women 
Medicine and science in sports and exercise  2009;41(2):10.1249/MSS.0b013e3181864c05.
INTRODUCTION
Month-to-month variation in physical activity levels in a cohort of post-menopausal women participating in a single site clinical trial undergoing lifestyle intervention was investigated prior to and after lifestyle intervention.
METHODS
Participants were Caucasian and African-American women (mean age 57.0 ± 3.0) from the Women On the Move through Activity and Nutrition (WOMAN) study. Physical activity was measured subjectively by questionnaire and objectively by pedometer at baseline and at the 18-month follow-up.
RESULTS
At baseline, prior to intervention, pedometer steps were highest in the summer months (7,616 steps/day), lower in the fall (6,293 steps/day), lowest in winter (5,304 steps/day), and then rebounded in the spring (5,850 steps/day). Physical activity estimates from the past-week subjective measure followed the same seasonal pattern. After 18-months, the lifestyle change group significantly increased their pedometer step counts when compared to the health education group (p<0.0001). At 18-months, pedometer step counts for the health education group followed a pattern similar to that found in the entire group prior to intervention, whereas, month-to-month step counts for the lifestyle change group appeared to remain consistent throughout the year.
CONCLUSIONS
These results confirm previous reports that suggest physical activity levels fluctuate throughout the year. Lifestyle intervention, which includes a physical activity component, not only increases step counts, but appears to reduce some of variation in physical activity levels over the course of a year in post-menopausal women.
doi:10.1249/MSS.0b013e3181864c05
PMCID: PMC3880933  PMID: 19127194
pedometer; seasonality; post-menopause; lifestyle intervention
8.  Steps that count! : The development of a pedometer-based health promotion intervention in an employed, health insured South African population 
BMC Public Health  2012;12:880.
Background
Physical activity (PA) has been identified as a central component in the promotion of health. PA programs can provide a low cost intervention opportunity, encouraging PA behavioral change while worksites have been shown to be an appropriate setting for implementing such health promotion programs. Along with these trends, there has been an emergence of the use of pedometers as a self-monitoring and motivational aid for PA.
This study determines the effectiveness of a worksite health promotion program comprising of a 10-week, pedometer-based intervention (“Steps that Count!”), and individualized email-based feedback to effect PA behavioral change.
Methods
The study is a randomized controlled trial in a worksite setting, using pedometers and individualized email-based feedback to increase steps per day (steps/d). Participant selection will be based on attendance at a corporate wellness event and information obtained, following the completion of a Health Risk Appraisal (HRA), in keeping with inclusion criteria for the study. All participants will, at week 1 (pre-intervention), be provided with a blinded pedometer to assess baseline levels of PA. Participants will be provided with feedback on pedometer data and identify strategies to improve daily PA towards current PA recommendations. Participants will thereafter be randomly assigned to the intervention group (INT) or control group (CTL). The INT will subsequently wear an un-blinded pedometer for 10 consecutive weeks.
Individualized feedback messages based on average steps per day, derived from pedometer data (INT) and general supportive/motivational messages (INT+CTL), will be provided via bi-weekly e-mails; blinded pedometer-wear will be conducted at week 12 (post-intervention: INT+CTL).
Discussion
The purpose of this paper is to outline the rationale behind, and the development of, an intervention aimed at improving ambulatory PA through pedometer use, combined with regular, individualized, email-based feedback. Pedometer-measured PA and individualized feedback may be a practical and easily applied intervention.
Trial registration
Number: DOH-27-0112-3951
doi:10.1186/1471-2458-12-880
PMCID: PMC3536647  PMID: 23075000
Pedometer; Health risk appraisal; Physical activity; Computer-based feedback
9.  A randomized trial comparing structured and lifestyle goals in an internet-mediated walking program for people with type 2 diabetes 
Background
The majority of individuals with type 2 diabetes do not exercise regularly. Pedometer-based walking interventions can help; however, pedometer-based interventions targeting only total daily accumulated steps might not yield the same health benefits as physical activity programs specifying a minimum duration and intensity of physical activity bouts.
Methods
This pilot randomized trial compared two goal-setting strategies: 1) lifestyle goals targeting total daily accumulated step counts and 2) structured goals targeting bout steps defined as walking that lasts for 10 minutes or longer at a pace of at least 60 steps per minute. We sought to determine which goal-setting strategy was more effective at increasing bout steps. Participants were sedentary adults with type 2 diabetes. All participants: wore enhanced pedometers with embedded USB ports; uploaded detailed, time-stamped step-count data to a website called Stepping Up to Health; and received automated step-count feedback, automatically calculated goals, and tailored motivational messages throughout the six-week intervention. Only the automated goal calculations and step-count feedback differed between the two groups. The primary outcome of interest was increase in steps taken during the previously defined bouts of walking (lasting at least 10 minutes or longer at a pace of at least 60 steps per minute) between baseline and end of the intervention.
Results
Thirty-five participants were randomized and 30 (86%) completed the pilot study. Both groups significantly increased bout steps, but there was no statistically significant difference between groups. Among study completers, bout steps increased by 1921 ± 2729 steps a day. Those who received lifestyle goals were more satisfied with the intervention (p = 0.006) and wore the pedometer more often (p < 0.001) than those who received structured goals.
Conclusion
In this six-week intervention, Lifestyle Goals group participants achieved increases in bout steps comparable to the increases seen in the Structured Goals group, representing almost a mile a day of additional moderate intensity bout activity. Pedometer-based walking programs that emphasize total accumulated step counts are more acceptable to participants and are as effective at increasing moderate intensity bouts of physical activity as programs that use structured goals.
Trial registration
NCT00151021
doi:10.1186/1479-5868-4-59
PMCID: PMC2212636  PMID: 18021411
10.  Anthropometric Changes Using a Walking Intervention in African American Breast Cancer Survivors: A Pilot Study 
Preventing Chronic Disease  2005;2(2):A16.
Introduction
African American women exhibit a higher mortality rate from breast cancer than do white women. African American women are more likely to gain weight at diagnosis, which may increase their risk of cancer recurrence and comorbidities. Physical activity has been shown to decrease body mass index and improve quality of life in cancer survivors. This study was designed to evaluate the feasibility and impact of a community-based exercise intervention in African American breast cancer survivors.
Methods
A theory-based eight-week community intervention using pedometers with scheduling, goal setting, and self-assessment was tested in a convenience sample of African American breast cancer survivors (n = 24). Data were collected at three time points to examine changes in steps walked per day, body mass index, and other anthropometric measures, attitudes, and demographic variables.
Results
Statistically significant increases in steps walked per day and attitude toward exercise as well as significant decreases in body mass index, body weight, percentage of body fat, and waist, hip, and forearm circumferences, as well as blood pressure, were reported from baseline to immediate post-intervention. Positive changes were retained or improved further at three-month follow-up except for attitude toward exercise. Participant retention rate during eight-week intervention was 92%.
Conclusion
Increasing walking for exercise, without making other changes, can improve body mass index, anthropometric measures, and attitudes, which are associated with improved quality of life and reduced risk of cancer recurrence. The high participant retention rate, along with significant study outcomes, demonstrate that among this sample of African American breast cancer survivors, participants were motivated to improve their exercise habits.
PMCID: PMC1327710  PMID: 15888227
11.  The 'Walking for Wellbeing in the West' randomised controlled trial of a pedometer-based walking programme in combination with physical activity consultation with 12 month follow-up: rationale and study design 
BMC Public Health  2008;8:259.
Background
Scotland has a policy aimed at increasing physical activity levels in the population, but evidence on how to achieve this is still developing. Studies that focus on encouraging real world participants to start physical activity in their settings are needed. The Walking for Well-being in the West study was designed to assess the effectiveness of a pedometer-based walking programme in combination with physical activity consultation. The study was multi-disciplinary and based in the community. Walking for Well-being in the West investigated whether Scottish men and women, who were not achieving the current physical activity recommendation, increased and maintained walking behaviour over a 12 month period. This paper outlines the rationale and design of this innovative and pragmatic study.
Methods
Participants were randomised into two groups: Group 1: Intervention (pedometer-based walking programme combined with a series of physical activity consultations); Group 2: Waiting list control for 12 weeks (followed by minimal pedometer-based intervention). Physical activity (primary outcome) was measured using pedometer step counts (7 day) and the International Physical Activity Questionnaire (long version). Psychological processes were measured using questionnaires relating to the Transtheoretical Model of Behaviour Change, mood (Positive and Negative Affect Schedule) and quality of life (Euroqol EQ-5D instrument). Physiological measures included anthropometric and metabolic outcomes. Environmental influences were assessed subjectively (Neighbourhood Quality of Life Survey) and objectively (neighbourhood audit tool and GIS mapping). The qualitative evaluation employed observation, semi-structured interviews and focus groups. A supplementary study undertook an economic evaluation.
Discussion
Data analysis is on-going. Walking for Well-being in the West will demonstrate if a pedometer based walking programme, in combination with physical activity consultation results in a sustainable increase in walking behaviour in this sample of Scottish adults over a 12 month period. The study will examine the complex relationships between behavioural change, health consequences and the role of the environment, in conjunction with the cost effectiveness of this approach and a detailed insight into the participants' experiences of the intervention.
Trial registration
Current Controlled Trials ISRCTN88907382
doi:10.1186/1471-2458-8-259
PMCID: PMC2518560  PMID: 18655723
12.  Exercise Training and Habitual Physical Activity A Randomized Controlled Trial 
Background
Exercise training reduces adiposity and risk of cardiovascular disease. However, the combined effects of habitual free-living physical activity and aerobic training on waist circumference, weight, fitness, and blood pressure in postmenopausal women are unknown.
Purpose
To evaluate the effects of habitual physical activity levels during aerobic training on weight, waist circumference, fitness, and blood pressure.
Design
Secondary analysis of an RCT. Original data collected April 2001 to June 2005 and analyzed in 2012.
Setting/participants
Postmenopausal women in a supervised exercise trial.
Intervention
Women (n=325) were randomized to 4, 8, or 12 kcal per kg per week of aerobic training or a control group for 6 months. All outcome measures were collected at baseline and follow-up. Changes in dependent variables within each training group were evaluated across tertiles of pedometer-determined habitual physical activity outside exercise training sessions.
Main outcome measures
Changes in waist circumference and weight.
Results
Reductions in waist circumference were significantly greater with higher steps/day accumulated outside exercise training compared to lower levels in the 4 (high: −4.8 cm vs low: −1.4 cm, p=0.03); 8 (high: −4.2 cm vs low: −0.4 cm, p=0.03), and 12 kcal per kg per week groups (high: −4.1 cm vs low: −0.7 cm, p=0.05). For all groups, p-trend < 0.03). A trend was observed for greater weight reduction with higher steps/day in the 4 kcal per kg per week group (p-trend= 0.04), but not for the other exercise doses. No effects were observed for blood pressure or fitness measures (all p>0.05).
Conclusions
In postmenopausal women, higher habitual physical activity while participating in aerobic training was associated with greater reductions in central adiposity, and was supportive of weight loss compared to lower levels.
doi:10.1016/j.amepre.2012.08.024
PMCID: PMC3504348  PMID: 23159258
13.  A web-based pedometer program in women with recent histories of gestational diabetes 
Aims
Women with remote histories of gestational diabetes mellitus (GDM) can reduce their diabetes risk through lifestyle changes, but the effectiveness of interventions in women with more recent histories of GDM has not been reported. Therefore, we conducted a pilot study of a low-intensity web-based pedometer program targeting glucose intolerance among women with recent GDM.
Methods
Women with a GDM delivery within the past 3 years were randomized to a 13-week intervention consisting of a structured web-based pedometer program which gave personalized steps-per-week goals, pedometers, and education regarding lifestyle modification vs. a letter about diabetes risk reduction and screening after delivery for GDM (control condition). The main outcome measures were change in fasting plasma glucose (FPG) and 2-hour glucose levels on a 75-gram oral glucose tolerance test (OGTT) between baseline and 13-week follow-up. Weight was a secondary outcome and behavioural constructs (self-efficacy, social support, risk perception) were also assessed.
Results
Forty-nine women were enrolled. At 13 week follow-up, women randomized to the intervention did not have significant changesin behavioural constructs, physical activity, or anthropometrics compared to women in the control group. Changes in FPG(−0.046 mmol/lvs. 0.038 mmol/l, p=0.65), 2-hour glucose values (−0.48 mmol/l vs. −0.42 mmol/l, p=0.91)and weight (−0.14 kg vs. −1.5 kg, p=0.13)were similar between the control and intervention groups, respectively.
Conclusions
Structured web-based education utilizing pedometersis feasible although uptake may be low. Such programs may need to be supplemented with additional measures in order to be effective for reduction of diabetes risk.
doi:10.1111/j.1464-5491.2011.03415.x
PMCID: PMC4139030  PMID: 21838764
gestational diabetes; pedometers; physical activity; internet; intervention
14.  Encouraging Physical Activity in Pediatric Asthma: A Case–Control Study of the Wonders of Walking (WOW) Program 
Pediatric pulmonology  2009;44(9):909-916.
Summary
Objectives
The complex overlap between asthma and obesity may be explained in part by activity avoidance in asthma. We compared responses to a walking intervention between matched groups of children with and without asthma. We expected youth with asthma to have lower baseline and post-intervention activity levels. Psychosocial, demographic, and physiologic correlates of activity were also examined.
Design/Participants
We compared baseline and post-intervention activity levels among 59 children aged 10–16 with well-controlled asthma and 59 healthy matched controls. Participants completed spirometry, physical examination, anthropometric measurement, and psychosocial questionnaires.
Intervention/Outcome Measure
Participants wore blinded calibrated pedometers for a baseline typical activity week, returning to complete the Wonders of Walking (WOW) intervention, followed by a week of post-intervention pedometer monitoring.
Results
Contrary to expectation, no differences between cases (median steps = 6,348/day) and controls (median steps = 6,825/day) in baseline activity were found. Response to the WOW intervention was comparable, with both groups demonstrating an increase of approximately 1,485 steps per day (equivalent to more than 5 additional miles walked during the post-intervention week). Health beliefs did not correlate to activity at baseline or intervention response. No significant associations between activity and asthma control, FEV1, or duration of diagnosis were found. Intervention response was comparable across racial/ethnic groups, children versus adolescents, and between normal weight and overweight youth.
Conclusions
Contrary to expectation, we found similar rates of objectively measured physical activity among youth with well-controlled asthma and controls. Importantly, we documented statistically significant increases in physical activity across both groups following a brief, pedometer-based intervention. The intervention was successful even among typically sedentary groups, and represents an effective, safe, and inexpensive walking program.
doi:10.1002/ppul.21077
PMCID: PMC3971919  PMID: 19658109
asthma; adolescent; obesity; physical activity; intervention
15.  Several steps/day indicators predict changes in anthropometric outcomes: HUB City Steps 
BMC Public Health  2012;12:983.
Background
Walking for exercise remains the most frequently reported leisure-time activity, likely because it is simple, inexpensive, and easily incorporated into most people’s lifestyle. Pedometers are simple, convenient, and economical tools that can be used to quantify step-determined physical activity. Few studies have attempted to define the direct relationship between dynamic changes in pedometer-determined steps/day and changes in anthropometric and clinical outcomes. Hence, the objective of this secondary analysis was to evaluate the utility of several descriptive indicators of pedometer-determined steps/day for predicting changes in anthropometric and clinical outcomes using data from a community-based walking intervention, HUB City Steps, conducted in a southern, African American population. A secondary aim was to evaluate whether treating steps/day data for implausible values affected the ability of these data to predict intervention-induced changes in clinical and anthropometric outcomes.
Methods
The data used in this secondary analysis were collected in 2010 from 269 participants in a six-month walking intervention targeting a reduction in blood pressure. Throughout the intervention, participants submitted weekly steps/day diaries based on pedometer self-monitoring. Changes (six-month minus baseline) in anthropometric (body mass index, waist circumference, percent body fat [%BF], fat mass) and clinical (blood pressure, lipids, glucose) outcomes were evaluated. Associations between steps/day indicators and changes in anthropometric and clinical outcomes were assessed using bivariate tests and multivariable linear regression analysis which controlled for demographic and baseline covariates.
Results
Significant negative bivariate associations were observed between steps/day indicators and the majority of anthropometric and clinical outcome changes (r = -0.3 to -0.2: P < 0.05). After controlling for covariates in the regression analysis, only the relationships between steps/day indicators and changes in anthropometric (not clinical) outcomes remained significant. For example, a 1,000 steps/day increase in intervention mean steps/day resulted in a 0.1% decrease in %BF. Results for the three pedometer datasets (full, truncated, and excluded) were similar and yielded few meaningful differences in interpretation of the findings.
Conclusions
Several descriptive indicators of steps/day may be useful for predicting anthropometric outcome changes. Further, manipulating steps/day data to address implausible values has little overall effect on the ability to predict these anthropometric changes.
doi:10.1186/1471-2458-12-983
PMCID: PMC3551779  PMID: 23153060
Pedometer; Steps/day; Anthropometric measures; African American
16.  A pedometer-based physical activity intervention for patients entering a maintenance cardiac rehabilitation program: a pilot study 
Purpose
To compare the effects of an individualized pedometer-driven physical activity (PA) intervention with the usual time-based PA recommendations given to patients entering a maintenance cardiac rehabilitation (CR) program.
Methods
A total of 18 subjects entering a maintenance CR program were recruited and completed the study. Subjects were randomized into pedometer feedback [PF: n=10 (2 women), 53.3±8.1 yrs] and usual care [UC: n=8 (2 women), 59.4±9.9 yrs] groups. New Lifestyles NL-1000 pedometers were used to monitor ambulatory PA. Subjects in both groups participated in the same maintenance CR program for a total of 8 weeks and all were encouraged to obtain a minimum of 30-40 min/d of moderate-vigorous-intensity physical activity (MVPA), on days they did not attend CR. Subjects in the PF group were given individualized daily stepcount goals (increase 10% of baseline steps/d each week) for weeks 2-8. Ambulatory PA was measured with pedometers, recording both total number of steps/d and min/d of MVPA. Measures were obtained during the first week of the maintenance CR program and during the 8th week. Data were also compared between days subjects attended and on days they did not attend.
Results
By the 8th week of CR, PF subjects increased daily stepcounts by 42% (2,297±1,606 steps/d, P=0.001), with a 36% increase on CR days (2,654±2,089 steps/d, P=0.003) and a 45% increase on days they did not attend CR (1,872±2,026 steps/d, P=0.017). There were no changes observed in the UC group.
Conclusions
Providing pedometers with individualized stepcount goals to patients entering a CR program was superior to the usual time-based PA recommendations for increasing PA.
doi:10.3978/j.issn.2223-3652.2013.03.03
PMCID: PMC3839193  PMID: 24282749
Cardiac rehabilitation; pedometer; physical activity
17.  Cost-Effectiveness of Interventions to Promote Physical Activity: A Modelling Study 
PLoS Medicine  2009;6(7):e1000110.
Linda Cobiac and colleagues model the costs and health outcomes associated with interventions to improve physical activity in the population, and identify specific interventions that are likely to be cost-saving.
Background
Physical inactivity is a key risk factor for chronic disease, but a growing number of people are not achieving the recommended levels of physical activity necessary for good health. Australians are no exception; despite Australia's image as a sporting nation, with success at the elite level, the majority of Australians do not get enough physical activity. There are many options for intervention, from individually tailored advice, such as counselling from a general practitioner, to population-wide approaches, such as mass media campaigns, but the most cost-effective mix of interventions is unknown. In this study we evaluate the cost-effectiveness of interventions to promote physical activity.
Methods and Findings
From evidence of intervention efficacy in the physical activity literature and evaluation of the health sector costs of intervention and disease treatment, we model the cost impacts and health outcomes of six physical activity interventions, over the lifetime of the Australian population. We then determine cost-effectiveness of each intervention against current practice for physical activity intervention in Australia and derive the optimal pathway for implementation. Based on current evidence of intervention effectiveness, the intervention programs that encourage use of pedometers (Dominant) and mass media-based community campaigns (Dominant) are the most cost-effective strategies to implement and are very likely to be cost-saving. The internet-based intervention program (AUS$3,000/DALY), the GP physical activity prescription program (AUS$12,000/DALY), and the program to encourage more active transport (AUS$20,000/DALY), although less likely to be cost-saving, have a high probability of being under a AUS$50,000 per DALY threshold. GP referral to an exercise physiologist (AUS$79,000/DALY) is the least cost-effective option if high time and travel costs for patients in screening and consulting an exercise physiologist are considered.
Conclusions
Intervention to promote physical activity is recommended as a public health measure. Despite substantial variability in the quantity and quality of evidence on intervention effectiveness, and uncertainty about the long-term sustainability of behavioural changes, it is highly likely that as a package, all six interventions could lead to substantial improvement in population health at a cost saving to the health sector.
Please see later in the article for Editors' Summary
Editors' Summary
Background
The human body needs regular physical activity throughout life to stay healthy. Physical activity—any bodily movement produced by skeletal muscles that uses energy—helps to maintain a healthy body weight and to prevent or delay heart disease, stroke, type 2 diabetes, colon cancer, and breast cancer. In addition, physically active people feel better and live longer than physically inactive people. For an adult, 30 minutes of moderate physical activity—walking briskly, gardening, swimming, or cycling—at least five times a week is sufficient to promote and maintain health. But at least 60% of the world's population does not do even this modest amount of physical activity. The daily lives of people in both developed and developing countries are becoming increasingly sedentary. People are sitting at desks all day instead of doing manual labor; they are driving to work in cars instead of walking or cycling; and they are participating less in physical activities during their leisure time.
Why Was This Study Done?
In many countries, the chronic diseases that are associated with physical inactivity are now a major public-health problem; globally, physical inactivity causes 1.9 million deaths per year. Clearly, something has to be done about this situation. Luckily, there is no shortage of interventions designed to promote physical activity, ranging from individual counseling from general practitioners to mass-media campaigns. But which intervention or package of interventions will produce the optimal population health benefits relative to cost? Although some studies have examined the cost-effectiveness of individual interventions, different settings for analysis and use of different methods and assumptions make it difficult to compare results and identify which intervention approaches should be give priority by policy makers. Furthermore, little is known about the cost-effectiveness of packages of interventions. In this study, the researchers investigate the cost-effectiveness in Australia (where physical inactivity contributes to 10% of deaths) of a package of interventions designed to promote physical activity in adults using a standardized approach (ACE-Prevention) to the assessment of the cost-effectiveness of health-care interventions.
What Did the Researchers Do and Find?
The researchers selected six interventions for their study: general practitioner “prescription” of physical activity; general practitioner referral to an exercise physiologist; a mass-media campaign to promote physical activity; the TravelSmart car use reduction program; a campaign to encourage the use of pedometers to increase physical activity; and an internet-based program. Using published data on the effects of physical activity on the amount of illness and death caused by breast and colon cancer, heart disease, stroke, and type 2 diabetes and on the effectiveness of each intervention, the researchers calculated the health outcomes of each intervention in disability-adjusted life years (DALY; a year of healthy life lost because of premature death or disability) averted over the lifetime of the Australian population. They also calculated the costs associated with each intervention offset by the costs associated with the five conditions listed above. These analyses showed that the pedometer program and the mass-media campaign were likely to be the most cost-effective interventions. These interventions were also most likely to be cost-saving. Referral to an exercise physiologist was the least cost-effective intervention. The other three interventions, though unlikely to be cost-saving, were likely to be cost-effective. Finally, a package of all six interventions would be cost-effective and would avert 61,000 DALYs, a third of what could be achieved if every Australian did 30 minutes of physical activity five times a week.
What Do These Findings Mean?
As in all modeling studies, these findings depend on the quality of the data and on the assumptions included by the researchers in their calculations. Unfortunately, there was substantial variability in the quantity and quality of evidence on the effectiveness of each intervention and uncertainty about the long-term effects of each intervention. Nevertheless, the findings presented in this study suggest that the assessment of the cost-effectiveness of a combination of interventions designed to promote physical activity might provide policy makers with some guidance about the best way to reduce the burden of disease caused by physical inactivity. More specifically, for Australia, these findings suggest that the package of the six interventions considered here is likely to provide a cost-effective way to substantially improve the health of the nation.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000110.
The World Health Organization provides information about physical activity and health (in several languages); it also provides an explanation of DALYs
The US Centers for Disease Control and Prevention provides information on physical activity for different age groups and for health professionals
The UK National Health Service information source Choices also explains the benefits of regular physical activity
MedlinePlus has links to other resources about exercise and physical fitness (in English and Spanish)
The University of Queensland Web site has more information on ACE-Prevention (Assessing Cost-Effectiveness Prevention)
doi:10.1371/journal.pmed.1000110
PMCID: PMC2700960  PMID: 19597537
18.  Nutrition and Exercise Prevent Excess Weight Gain in Overweight Pregnant Women 
Purpose
To determine the effect of a Nutrition and Exercise Lifestyle Intervention Program (NELIP) for overweight (OW) and obese (OB) pregnant women on pregnancy weight gain, birth weight, and maternal weight retention at 2 months postpartum.
Methods
This is a single-arm intervention matched by prepregnant body mass index, age, and parity to a historical cohort (4:1). Women with a prepregnancy body mass index of ≥25.0 kg·m−2 (N = 65) participated in a NELIP starting at 16–20 wk of pregnancy, continuing until delivery. NELIP consisted of an individualized nutrition plan with total energy intake of approximately 2000 kcal·d−1 (8360 kJ·d−1) and 40%–55% of total energy intake from carbohydrate. Exercise consisted of a walking program (30% HR reserve), three to four times per week, using a pedometer to count steps. Matched historical cohort (MC; N = 260) was from a large local perinatal database.
Results
Weight gained by women on the NELIP was 6.8 ± 4.1 kg (0.38 ± 0.2 kg·wk−1), with a total pregnancy weight gain of 12.0 ± 5.7 kg. Excessive weight gain occurred before NELIP began at 16 wk of gestation. Eighty percent of the women did not exceed recommended pregnancy weight gain on NELIP. Weight retention at 2 months postpartum was 2.2 ± 5.6 kg with no difference between the OW and the OB women on NELIP. Mean birth weight was not different between NELIP (3.59 ± 0.5 kg) and MC (3.56 ± 0.6 kg, P > 0.05).
Conclusions
NELIP reduces the risk of excessive pregnancy weight gain with minimal weight retention at 2 months postpartum in OW and OB women. This intervention may assist OW and OB women in successful weight control after childbirth.
doi:10.1249/MSS.0b013e3181b5419a
PMCID: PMC2886034  PMID: 20083959 CAMSID: cams1074
INTERVENTION; HEALTHY LIFESTYLE; OBESE; GESTATION
19.  A randomized controlled trial on a multicomponent intervention for overweight school-aged children – Copenhagen, Denmark 
BMC Pediatrics  2014;14(1):273.
Background
Obesity amongst children is a growing problem worldwide. In contrast to adults, little is known on the effects of controlled weight loss on components of the metabolic syndrome in children. The primary aim of the study was to evaluate the effects of a 20-week exercise and diet guidance intervention on body mass index (BMI) in a group of overweight children. Our hypothesis was an observed reduction in BMI and secondarily in body fat content, insulin insensitivity, and other components of the metabolic syndrome in the intervention group.
Methods
School children from Copenhagen were randomly allocated to an intervention group (n = 19) or a control group (n = 19). Anthropometric assessment, whole body dual-energy X-ray absorptiometry scan, two hours oral glucose tolerance test, steps measured by pedometer, and fitness tests were measured at baseline and at 20 weeks.
Results
Thirty-seven children (30 girls) participated at baseline, aged 8.7 ± 0.9 years with a BMI of 21.8 ± 3.7 kg/m2 (mean ± SD), and 36 children completed the study. The intervention group decreased their BMI (the intervention effect is the difference in change between the groups adjusted for the respective baseline values (DELTA) = -2.0 kg/m2, 95% CI: -2.5; -1.5, P <0.001), total body mass (DELTA = -4.0 kg, 95% CI: -4.9; -3.0, P <0.001), and fat mass (DELTA = -3.3 kg, 95% CI: -4.2; -2.7, P <0.001) compared to the control group after the intervention. The intervention group displayed decreased waist, hip and waist-to-height ratio (WHtR) (all three variables; P <0.001), area under curve for plasma insulin (P <0.05), and increased mean and minimum steps/day (P <0.05 and P <0.01, respectively).
Conclusions
The multicomponent intervention had significant favorable effects on BMI, weight, WHtR, mean and minimum steps/day, and fat mass. In addition, similar beneficial metabolic effects were found in the children as shown in adults, e.g. increase in peripheral insulin sensitivity.
Trial registration
Clinicaltrials.gov Identifier number NCT01660789.
doi:10.1186/1471-2431-14-273
PMCID: PMC4287468  PMID: 25330848
Overweight children; Obesity; Randomized controlled trial; Multicomponent intervention; Physical activity; Diet counseling; Body mass index; Blood glucose; Insulin; Insulin resistance
20.  Parent-Targeted Mobile Phone Intervention to Increase Physical Activity in Sedentary Children: Randomized Pilot Trial 
JMIR mHealth and uHealth  2014;2(4):e48.
Background
Low levels of moderate-to-vigorous physical activity are associated with adverse health consequences.
Objective
The intent of the study was to determine the feasibility and efficacy of a 12-week physical activity promotion program targeting children, which was delivered to parents through mobile phones.
Methods
Potential participants were recruited through advertisements placed in the newspaper, local hospitals and schools, and an email listserv. Sedentary children aged 6-10 years were randomly assigned to a minimal (MIG) or intensive (IIG) intervention group. Parents in the MIG were given a goal to increase (within 1 month) and maintain their child’s activity at 6000 pedometer steps/day above their baseline levels and to monitor their child’s steps daily. Parents in the IIG were given the same steps/day and monitoring goals, in addition to text messages and articles containing additional behavioral strategies (based on the Social Cognitive Theory) designed to promote their child’s physical activity. The intervention components were delivered via mobile phone. Anthropometrics, body composition, and questionnaires were administered in a clinic. Children wore a New Lifestyles pedometer (NL-1000) each day throughout the intervention and parents were to monitor their child’s step counts daily.
Results
Out of 59 children who screened for the study, a total of 27 children (mean age 8.7, SD 1.4 years; 56%, 15/27 female; 59%, 16/27 African American) were enrolled and completed the study. Overall, 97.90% (2220/2268; 98.20%, 1072/1092 for MIG; 97.60%, 1148/1176 for IIG) of expected step data were successfully entered by the parent or study coordinator. Parents in the MIG and IIG were sent approximately 7 and 13 text messages per week, respectively, averaged over the course of the study. IIG parents accessed an average of 6.1 (SD 4.4) articles over the course of the intervention and accessed a fewer number of articles in the last month compared to the first 2 months of the study (P=.002). Children in both the MIG and IIG significantly increased their physical activity, averaged over 12 weeks, by 1427.6 (SD 583.0; P=.02) and 2832.8 (SD 604.9; P<.001) steps/day above baseline, respectively. The between group difference was not statistically significant (P=.10; effect size=.40), nor was the group by time interaction (P=.57). Regardless of group assignment, children who significantly increased their physical activity reported greater increases in physical activity enjoyment (P=.003). The number of behavioral articles accessed by IIG parents was significantly correlated with change in children’s steps/day (r=.575, P=.04). Changes in children’s steps/day were unrelated to changes in their body composition, mood, and food intake.
Conclusions
Parent-targeted mobile phone interventions are feasible, yet more intense interventions may be needed to support parents’ efforts to increase their children’s physical activity to levels that approximate national recommendations.
Trial Registration
Clinicaltrials.gov NCT01551108; http://clinicaltrials.gov/show/NCT01551108 (Archived by WebCite at http://www.webcitation.org/6TNEOzXNX).
doi:10.2196/mhealth.3420
PMCID: PMC4260004  PMID: 25386899
mobile health; physical activity intervention; child; parents; pedometers; text messaging
21.  Multicomponent intervention to reduce daily sedentary time: a randomised controlled trial 
BMJ Open  2013;3(10):e003261.
Objectives
To test the efficacy of a multicomponent technology intervention for reducing daily sedentary time and improving cardiometabolic disease risk among sedentary, overweight university employees.
Design
Blinded, randomised controlled trial.
Setting
A large south-eastern university in the USA.
Participants
49 middle-aged, primarily female, sedentary and overweight adults working in sedentary jobs enrolled in the study. A total of 40 participants completed the study.
Interventions
Participants were randomised to either: (1) an intervention group (N=23; 47.6+9.9 years; 94.1% female; 33.2+4.5 kg/m2); (2) or wait-list control group (N=17; 42.6+8.9 years; 86.9% female; 31.7+4.9 kg/m2). The intervention group received a theory-based, internet-delivered programme, a portable pedal machine at work and a pedometer for 12 weeks. The wait-list control group maintained their behaviours for 12 weeks.
Outcome measures
Primary (sedentary and physical activity behaviour measured objectively through StepWatch) and secondary (heart rate, blood pressure, height, weight, waist circumference, per cent body fat, cardiorespiratory fitness, fasting lipids) outcomes were measured at baseline and postintervention (12 weeks). Exploratory outcomes including intervention compliance and process evaluation measures were also assessed postintervention.
Results
Compared to controls, the intervention group reduced daily sedentary time (mean change (95%CI): −58.7 min/day (−118.4 to 0.99; p<0.01)) after adjusting for baseline values and monitor wear time. Intervention participants logged on to the website 71.3% of all intervention days, used the pedal machine 37.7% of all working intervention days and pedalled an average of 31.1 min/day.
Conclusions
These findings suggest that the intervention was engaging and resulted in reductions in daily sedentary time among full-time sedentary employees. These findings hold public health significance due to the growing number of sedentary jobs and the potential of these technologies in large-scale worksite programmes.
Trial Registration
ClinicalTrials.gov #NCT01371084.
doi:10.1136/bmjopen-2013-003261
PMCID: PMC3808782  PMID: 24141969
sedentary; worksite; technology
22.  Design of the New Life(style) study: a randomised controlled trial to optimise maternal weight development during pregnancy. [ISRCTN85313483] 
BMC Public Health  2006;6:168.
Background
Preventing excessive weight gain during pregnancy is potentially important in the prevention of overweight and obesity among women of childbearing age. However, few intervention studies aiming at weight management during pregnancy have been performed and most of these interventions were not as successful as expected. In this paper the design of the New Life(style) study is described as well as the content of the individually tailored intervention program, which focuses on controlling weight development during pregnancy.
Methods
The effectiveness of the New Life(style) intervention program versus usual care by midwives is evaluated in a randomised controlled trial. Women who expect their first child and visit one of the participating midwifery practices are included. The intervention is standardised in a protocol and executed by trained counsellors with the women who are randomised in the intervention group. During 5 sessions – at 18, 22, 30 and 36 weeks of pregnancy and at 8 weeks postpartum – individual weight gain is discussed in relation to weight gain guidelines for pregnant women of the American Institute of Medicine. Counsellors coach the women to maintain or optimise a healthy lifestyle, in a period of drastic physical and mental changes. Data is collected at 15, 25, 35 weeks of pregnancy and at 6, 26, and 52 weeks after delivery. Primary outcome measures are body weight, BMI, and skinfold thickness. Secondary outcome measures include physical activity, nutrition and blood levels of factors that are associated with energy homeostasis.
Discussion
Results of the current RCT will improve the knowledge of determinants of weight gain during pregnancy, weight retention after childbirth and of the effectiveness of the intervention program that is described. Caregivers and researchers in the field of health promotion are offered more insight in specific elements of the New Life(style) intervention program.
doi:10.1186/1471-2458-6-168
PMCID: PMC1523339  PMID: 16800869
23.  Changes in weight and health behaviors after pregnancies complicated by gestational diabetes mellitus: The CARDIA Study 
Obesity (Silver Spring, Md.)  2013;21(6):1269-1275.
We compared pre- to post-pregnancy change in weight, body mass index (BMI), waist circumference, diet and physical activity in women with and without gestational diabetes mellitus (GDM).
Using the Coronary Artery Risk Development in Young Adults (CARDIA) study we identified women with at least one pregnancy during 20 years of follow-up (n=1,488 with 3,125 pregnancies). We used linear regression with generalized estimating equations to compare pre- to post-pregnancy changes in health behaviors and anthropometric measurements between 137 GDM pregnancies and 1,637 non GDM pregnancies, adjusted for parity, age at delivery, outcome measure at the pre-pregnancy exam, race, education, mode of delivery, and interval between delivery and post-pregnancy examination.
Compared with women without GDM in pregnancy, women with GDM had higher pre-pregnancy mean weight (158.3 vs. 149.6 lb, p=0.011) and BMI (26.7 vs. 25.1 kg/m2, p=0.002), but non-significantly lower total daily caloric intake and similar levels of physical activity. Both GDM and non GDM groups had higher average postpartum weight of 7–8 lbs and decreased physical activity on average 1.4 years after pregnancy. Both groups similarly increased total caloric intake but reduced fast food frequency. Pre- to post- pregnancy changes in body weight, BMI, waist circumference, physical activity and diet did not differ between women with and without GDM in pregnancy.
Following pregnancy women with and without GDM increased caloric intake, BMI and weight, decreased physical activity, but reduced their frequency of eating fast food. Given these trends, postpartum lifestyle interventions, particularly for women with GDM, are needed to reduce obesity and diabetes risk.
doi:10.1002/oby.20133
PMCID: PMC3735637  PMID: 23666593
24.  WalkMore: a randomized controlled trial of pedometer-based interventions differing on intensity messages 
BMC Public Health  2014;14:168.
Background
Pedometer-based programs have elicited increased walking behaviors associated with improvements in blood pressure in sedentary/low active postmenopausal women, a population at increased risk of cardiovascular disease. Such programs typically encourage increasing the volume of physical activity with little regard for its intensity. Recent advances in commercially available pedometer technology now permit tracking of both steps/day and time in moderate (or greater) intensity physical activity on a daily basis. It is not known whether the dual message to increase steps/day while also increasing time spent at higher intensity walking will elicit additional improvements in blood pressure relative to a message to only focus on increasing steps/day. The purpose of this paper is to present the rationale, study design, and protocols employed in WalkMore, a 3-arm 3-month blinded and randomized controlled trial (RCT) designed to compare the effects of two community pedometer-based walking interventions (reflecting these separate and combined messages) relative to a control group on blood pressure in sedentary/low active post-menopausal women, a population at increased risk of cardiovascular disease.
Methods/Design
120 sedentary/low active post-menopausal women (45-74 years of age) will be randomly assigned (computer-generated) to 1 of 3 groups: A) 10,000 steps/day (with no guidance on walking intensity/speed/cadence; BASIC intervention, n = 50); B) 10,000 steps/day and at least 30 minutes in moderate intensity (i.e., a cadence of at least 100 steps/min; ENHANCED intervention, n = 50); or a Control group (n = 20). An important strength of the study is the strict control and quantification of the pedometer-based physical activity interventions. The primary outcome is systolic blood pressure. Secondary outcomes include diastolic blood pressure, anthropometric measurements, fasting blood glucose and insulin, flow mediated dilation, gait speed, and accelerometer-determined physical activity and sedentary behavior.
Discussion
This study can make important contributions to our understanding of the relative benefits that walking volume and/or intensity may have on blood pressure in a population at risk of cardiovascular disease.
Trial registration
ClinicalTrials.gov Record NCT01519583, January 18, 2012
doi:10.1186/1471-2458-14-168
PMCID: PMC3931482  PMID: 24528783
Walking; Physical activity; Pedometer; Accelerometer; Exercise
25.  A cognitive-behavioural pedometer-based group intervention on physical activity and sedentary behaviour in individuals with type 2 diabetes 
Health Education Research  2010;25(5):724-736.
The purpose of this study was to investigate the benefits of a pedometer and a cognitive-behavioural group intervention for promoting physical activity (PA) in type 2 diabetes patients. We recruited 41 participants and randomized them into an intervention group (IG) (n = 20) and a control group (CG) (n = 21). The intervention consisted of five sessions within 12 weeks, a booster session after 22 weeks and a pedometer. Primary outcome was PA assessed by accelerometer (minutes per day) and pedometer (steps per day). Secondary outcomes were weight, body mass index, blood pressure, haemoglobin A1c and total cholesterol. After 12 weeks, the IG increased with more than 2000 steps day−1 compared with the CG, whereas sedentary behaviour decreased more than 1 hour day−1 in the IG and showed no change in the CG. There was no intervention effect on the accelerometer-based PA nor on health measurements. After 1 year, the increase in steps per day remained significant in the IG, but sedentary activity increased again to baseline levels. This pilot study showed that the combination of a 12-week cognitive-behavioura intervention and a pedometer has a significant short-term impact on daily steps and sedentary behaviour but that the effects on total PA and long-term effects were limited.
doi:10.1093/her/cyq017
PMCID: PMC2936553  PMID: 20338978

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