Dataset Information

Weight gain prevention among black women in the rural community health center setting: the Shape Program.

ABSTRACT: Nearly 60% of black women are obese. Despite their increased risk of obesity and associated chronic diseases, black women have been underrepresented in clinical trials of weight loss interventions, particularly those conducted in the primary care setting. Further, existing obesity treatments are less effective for this population. The promotion of weight maintenance can be achieved at lower treatment intensity than can weight loss and holds promise in reducing obesity-associated chronic disease risk. Weight gain prevention may also be more consistent with the obesity-related sociocultural perspectives of black women than are traditional weight loss approaches.We conducted an 18-month randomized controlled trial (the Shape Program) of a weight gain prevention intervention for overweight black female patients in the primary care setting. Participants include 194 premenopausal black women aged 25 to 44?years with a BMI of 25-34.9?kg/m2. Participants were randomized either to usual care or to a 12-month intervention that consisted of: tailored obesogenic behavior change goals, self-monitoring via interactive voice response phone calls, tailored skills training materials, 12 counseling calls with a registered dietitian and a 12-month YMCA membership.Participants are followed over 18?months, with study visits at baseline, 6-, 12- and 18-months. Anthropometric data, blood pressure, fasting lipids, fasting glucose, and self-administered surveys are collected at each visit. Accelerometer data is collected at baseline and 12-months.At baseline, participants were an average of 35.4?years old with a mean body mass index of 30.2?kg/m2. Participants were mostly employed and low-income. Almost half of the sample reported a diagnosis of hypertension or prehypertension and 12% reported a diagnosis of diabetes or prediabetes. Almost one-third of participants smoked and over 20% scored above the clinical threshold for depression.The Shape Program utilizes an innovative intervention approach to lower the risk of obesity and obesity-associated chronic disease among black women in the primary care setting. The intervention was informed by behavior change theory and aims to prevent weight gain using inexpensive mobile technologies and existing health center resources. Baseline characteristics reflect a socioeconomically disadvantaged, high-risk population sample in need of evidence-based treatment strategies.The trial is registered with clinicaltrials.gov NCT00938535.

SUBMITTER: Foley P

PROVIDER: S-EPMC3439671 | biostudies-literature | 2012 Jun

REPOSITORIES: biostudies-literature

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Weight gain prevention among black women in the rural community health center setting: the Shape Program.

Foley Perry P Levine Erica E Askew Sandy S Puleo Elaine E Whiteley Jessica J Batch Bryan B Heil Daniel D Dix Daniel D Lett Veronica V Lanpher Michele M Miller Jade J Emmons Karen K Bennett Gary G

BMC public health 20120615

<h4>Background</h4>Nearly 60% of black women are obese. Despite their increased risk of obesity and associated chronic diseases, black women have been underrepresented in clinical trials of weight loss interventions, particularly those conducted in the primary care setting. Further, existing obesity treatments are less effective for this population. The promotion of weight maintenance can be achieved at lower treatment intensity than can weight loss and holds promise in reducing obesity-associat ...[more]

PMID: 22537222

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Project description:Rates of physical inactivity are high among Black women living in the United States with overweight or obesity, especially those living in the rural South. This study was conducted to determine if an efficacious weight gain prevention intervention increased moderate-vigorous physical activity (MVPA).The Shape Program, a weight gain prevention intervention implemented in community health centers in rural North Carolina, was designed for socioeconomically disadvantaged Black women with overweight or obesity. MVPA was measured using accelerometers, and summarized into 1- and 10-min bouts. We employed analyses of covariance (ANCOVA) to assess the relationship between changes in MVPA over 12 months, calculated as a change score, and intervention assignment (intervention versus usual care).Participants completing both baseline and 12-month accelerometer assessments (n = 121) had a mean age of 36.1 (SD = 5.43) years and a mean body mass index of 30.24 kg/m2 (SD = 2.60). At baseline, 38% met the physical activity recommendation (150 min of MVPA/week) when assessed using 10-min bouts, and 76% met the recommendation when assessed using 1-min bouts. There were no significant differences in change in MVPA participation among participants randomized to the intervention from baseline to 12-months using 1-min bouts (adjusted intervention mean [95% CI]: 20.50 [-109.09 to 150.10] vs. adjusted usual care mean [95% CI]: -80.04 [-209.21 to 49.13], P = .29), or 10-min bouts (adjusted intervention mean [95% CI]: 7.39 [-83.57 to 98.35] vs. adjusted usual care mean [95% CI]: -17.26 [-107.93 to 73.40], P = .70).Although prior research determined that the Shape intervention promoted weight gain prevention, MVPA did not increase significantly among intervention participants from baseline to 12 months. The classification of bouts had a marked effect on the prevalence estimates of those meeting physical activity recommendations. More research is needed to understand how to promote increased MVPA in weight gain prevention interventions.This study is registered at www.clinicaltrials.gov database (No. NCT00938535. Retrospectively Registered 7/10/2009).

Project description:BackgroundThe prevalence of obesity and its associated comorbidities continue to rise in the United States. Populations who are uninsured and from racial and ethnic minority groups continue to be disproportionately affected. These populations also experience fewer clinically meaningful outcomes in most weight loss trials. Weight gain prevention presents a useful strategy for individuals who experience barriers to weight loss. Given the often-limited weight management resources available to patients in primary care settings serving vulnerable patients, evaluating interventions with pragmatic designs may help inform the design of comprehensive obesity care delivered in primary care.ObjectiveThis study aims to evaluate the effectiveness of Balance, a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention, delivered to patients receiving primary care within federally qualified community health centers.MethodsBalance was a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention delivered to individuals who had a BMI of 25-40 kg/m2, spoke English or Spanish, and were receiving primary care within a network of federally qualified community health centers in North Carolina. The Balance intervention was designed to encourage behavioral changes that result in a slight energy deficit. Intervention participants received tailored goal setting and tracking, skills training, self-monitoring, and responsive health coaching from registered dietitians. Weight was measured at regular primary care visits and documented in the electronic health record. We compared the percentage of ≤3% weight gain in each arm at 24 months after randomization-our primary outcome-using individual empirical best linear unbiased predictors from the linear mixed-effects model. We used individual empirical best linear unbiased predictors from participants with at least 1 electronic health record weight documented within a 6-month window centered on the 24-month time point.ResultsWe randomized 443 participants, of which 223 (50.3%) participants were allocated to the intervention arm. At baseline, participants had a mean BMI of 32.6 kg/m2. Most participants were Latino or Hispanic (n=200, 45.1%) or non-Latino or Hispanic White (n=115, 26%). In total, 53% (n=235) of participants had at least 1 visit with weight measured in the primary time window. The intervention group had a higher proportion with ≤3% weight gain at 6 months (risk ratio=1.12, 95% CI 0.94-1.28; risk difference=9.5, 95% CI -4.5 to 16.4 percentage points). This difference attenuated to the null by 24 months (risk ratio=1.00, 95% CI 0.82-1.20; risk difference=0.2, 95% CI -12.1 to 11.0 percentage points).ConclusionsIn adults with overweight or obesity receiving primary care at a community health center, we did not find long-term evidence to support the dissemination of a digital health intervention for weight gain prevention.Trial registrationClinicalTrials.gov NCT03003403; https://clinicaltrials.gov/study/NCT03003403.International registered report identifier (irrid)RR2-10.1186/s12889-019-6926-7.

Project description:PurposeTo determine characteristics of weight gain prevention programs that facilitate engagement.DesignRandomized factorial experiment (5 × 2).SettingRecruited nationally online.ParticipantsAdults aged 18 to 75 with body mass index ≥25 who decline a behavioral weight loss intervention (n = 498).MeasuresParticipants were randomly presented with one of 10 possible descriptions of hypothetical, free weight gain prevention programs that were all low dose and technology-based but differed in regard to 5 behavior change targets (self-weighing only; diet only; physical activity only; combined diet, physical activity, and self-weighing; or choice between diet, physical activity, and self-weighing targets) crossed with 2 financial incentive conditions (presence or absence of incentives for self-monitoring). Participants reported willingness to join the programs, perceived program effectiveness, and reasons for declining enrollment.AnalysisLogistic regression and linear regression to test effects of program characteristics offered on willingness to initiate programs and programs' perceived effectiveness, respectively. Content analyses for open-ended text responses.ResultsParticipants offered the self-weighing-only programs were more willing to initiate than those offered the programs targeting all 3 behaviors combined (50% vs 36%; odds ratio [OR] = 1.79; 95% confidence interval [CI], 1.01-3.13). Participants offered the programs with financial incentives were more willing to initiate (50% vs 33%; OR = 2.08; 95% CI, 1.44-2.99) and anticipated greater intervention effectiveness (β = .34, P = .02) than those offered no financial incentives. Reasons for declining to initiate included specific program features, behavior targets, social aspects, and benefits.ConclusionTargeting self-weighing and providing financial incentives for self-monitoring may result in greater uptake of weight gain prevention programs.Study preregistrationhttps://osf.io/b9zfh, June 19, 2018.

Project description:BackgroundGoal setting aids health-related behavior changes; however, the influence of different types of goals on weight loss remains unclear.ObjectiveWe aimed to investigate the association of 3 aspects of goal setting with weight and program dropout over a 24-week period.MethodsThis study was a prospective longitudinal analysis of participants in a 12-week digital behavioral weight loss program. Weight and engagement data for eligible participants (N=36,794) were extracted from the database. Eligible participants were adults in the United Kingdom who had enrolled in the program, had a BMI ≥25 kg/m2, and a weight reading recorded at baseline. Three aspects of goal setting were self-reported at enrollment: weight loss motivation (appearance, health, fitness, or self-efficacy), overall goal preference (low, medium, or high), and percentage weight loss goal (<5%, 5%-10%, or >10%). Weight was measured at 4, 12, and 24 weeks. Mixed models for repeated measures were used to explore the association between goals and weight across the 24-week period. To measure sustained weight change, the primary outcome was weight at 24 weeks. We explored dropout rates over the 24-week period by goal and whether engagement mediated the association between goals and weight loss.ResultsOf the 36,794 participants (mean 46.7, SD 11.1 years; 33,902/36,794, 92.14% female) included in the cohort, 13.09% (n=4818) reported weight at 24 weeks. Most participants set goals of 5%-10% weight loss (23,629/36,794, 64.22%), but setting goals for >10% was associated with greater weight loss (mean difference 5.21 kg, 95% CI 5.01-5.41; P<.001). There was no difference between goals of 5%-10% and <5% (mean difference 0.59 kg, 95% CI 0.00-1.18; P=.05). Appearance was the most prevalent motivational factor (14,736/36,794, 40.05%), but health and fitness were associated with greater weight losses (mean difference health vs appearance 1.40 kg, 95% CI 1.15-1.65; P<.001 and mean difference fitness vs appearance 0.38 kg, 95% CI 0.05-0.70; P=.03). Goal preference had no association with weight. Engagement was an independent predictor of weight loss but not a mediator of the effect of goal setting. At 24 weeks, those who set goals of >10% were less likely to drop out compared with 5%-10% goals (odds ratio [OR] 0.40, 95% CI 0.38-0.42; P<.001); those who liked to set overall high goals were more likely to drop out compared with medium goals (OR 1.20, 95% CI 1.11-1.29; P<.001); and those motivated by fitness or health were less likely to drop out compared with appearance (OR 0.92, 95% CI 0.85-0.995; P=.04 and OR 0.84, 95% CI 0.78-0.89; P<.001, respectively).ConclusionsSetting higher weight loss goals and being motivated by health or fitness were associated with greater weight loss and lower likelihood of dropout. Randomized trials for setting these types of goals are required to confirm causality.

Project description:BackgroundClinical trial implementation continues to shift toward pragmatic design, with the goal of increasing future adoption in clinical practice. Yet, few pragmatic trials within clinical settings have qualitatively assessed stakeholder input, especially from those most impacted by research implementation and outcomes, i.e., providers and staff. Within this context, we conducted a qualitative study of the implementation of a pragmatic digital health obesity trial with employees at a Federally qualified health center (FQHC) network in central North Carolina.MethodsParticipant recruitment was conducted through purposive sampling of FQHC employees from a variety of backgrounds. Two researchers conducted semi-structured qualitative interviews and collected demographic data. Interviews were digitally recorded, professionally transcribed and double-coded by two independent researchers using NVivo 12. Coding discrepancies were reviewed by a third researcher until intercoder consensus was reached. Responses were compared within and across participants to elucidate emergent themes.ResultsEighteen qualitative interviews were conducted, of whom 39% provided direct medical care to patients and 44% worked at the FQHC for at least seven years. Results illuminated the challenges and successes of a pragmatically designed obesity treatment intervention within the community that serves medically vulnerable patients. Although limited time and staffing shortages may have challenged recruitment processes, respondents described early buy-in from leadership; an alignment of organizational and research goals; and consideration of patient needs as facilitators to implementation. Respondents also described the need for personnel power to sustain novel research interventions and considerations of health center resource constraints.ConclusionsResults from this study contribute to the limited literature on pragmatic trials utilizing qualitative methods, particularly in community-based obesity treatment. To continue to merge the gaps between research implementation and clinical care, qualitative assessments that solicit stakeholder input are needed within pragmatic trial design. For maximum impact, researchers may wish to solicit input from a variety of professionals at trial onset and ensure that shared common goals and open collaboration between all partners is maintained throughout the trial.Trial registrationThis trial was registered with ClinicalTrials.gov (NCT03003403) on December 28, 2016.

Project description:BackgroundCardiovascular disease is the leading cause of death in the United States and places substantial burden on the health care system. Rural populations, especially women, have considerably higher rates of cardiovascular disease, influenced by poverty, environmental factors, access to health care, and social and cultural attitudes and norms.Methods/designThis community-based study will be a two-arm randomized controlled efficacy trial comparing a multi-level, community program (Strong Hearts, Healthy Communities) with a minimal intervention control program (Strong Hearts, Healthy Women). Strong Hearts, Healthy Communities was developed by integrating content from three evidence-based programs and was informed by extensive formative research (e.g. community assessments, focus groups, and key informant interviews). Classes will meet twice weekly for one hour for 24 weeks and focus on individual-level skill building and behavior change; social and civic engagement are also core programmatic elements. Strong Hearts, Healthy Women will meet monthly for hour-long sessions over the 24 weeks covering similar content in a general, condensed format. Overweight, sedentary women 40 years of age and older from rural, medically underserved communities (12 in Montana and 4 in New York) will be recruited; sites, pair-matched based on rurality, will be randomized to full or minimal intervention. Data will be collected at baseline, midpoint, intervention completion, and six-month, one-year, and eighteen months post-intervention. The primary outcome is change in body weight; secondary outcomes include physiologic, anthropometric, behavioral, and psychosocial variables. In the full intervention, engagement of participants' friends and family members in partnered activities and community events is an intervention target, hypothesizing that there will be a reciprocal influence of physical activity and diet behavior between participants and their social network. Family members and/or friends will be invited to complete baseline and follow-up questionnaires about their health behaviors and environment, height and weight, and attitudes and beliefs.DiscussionStrong Hearts, Healthy Communities aims to reduce cardiovascular disease morbidity and mortality, improve quality of life, and reduce cardiovascular disease-related health care burden in underserved rural communities. If successful, the long-term goal is for the program to be nationally disseminated, providing a feasible model to reduce cardiovascular disease in rural settings.Trial registrationClinicalTrials.gov Identifier: NCT02499731 Registered on July 1, 2015.

Dataset Information

Weight gain prevention among black women in the rural community health center setting: the Shape Program.

Publications

Weight gain prevention among black women in the rural community health center setting: the Shape Program.

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