Correction: Weight Gain Prevention Outcomes From a Pragmatic Digital Health Intervention With Community Health Center Patients: Randomized Controlled Trial.

[This corrects the article DOI: 10.2196/50330.].

Weight Gain Prevention Outcomes From a Pragmatic Digital Health Intervention With Community Health Center Patients: Randomized Controlled Trial.

BACKGROUND: The 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. OBJECTIVE: This 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. METHODS: Balance 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. RESULTS: We 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). CONCLUSIONS: In 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 REGISTRATION: ClinicalTrials.gov NCT03003403; https://clinicaltrials.gov/study/NCT03003403. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-019-6926-7.

Recruitment of diverse community health center patients in a pragmatic weight gain prevention trial.

Introduction: Pragmatic trials are needed to establish evidence-based obesity treatment in primary care settings, particularly in community health centers (CHCs) that serve populations at heightened risk of obesity. Recruiting a representative trial sample is a critical first step to informing care for diverse communities. We described recruitment strategies utilized in a pragmatic obesity trial and assessed the sociodemographic characteristics and odds of enrollment by recruitment strategy. Methods: We analyzed data from Balance, a pragmatic trial implemented within a network of CHCs. We recruited participants via health center-based and electronic health record (EHR)-informed mail recruitment. We analyzed associations between sociodemographic characteristics and the return rate of patient authorization forms (required for participation) from EHR-informed mail recruitment. We also compared sociodemographic characteristics and randomization odds by recruitment strategy after returning authorization forms. Results: Of the individuals recruited through EHR-informed mail recruitment, females were more likely than males to return authorization forms; however, there were no differences in rates of return by preferred language (English/Spanish) or age. Females; underrepresented racial and ethnic groups; Spanish speakers; younger adults; and those with lower education levels were recruited more successfully in the health center. In contrast, their counterparts were more responsive to mail recruitment. Once authorization forms were returned, the odds of being randomized did not significantly differ by recruitment method. Conclusion: Health center-based recruitment was essential to meeting recruitment targets in a pragmatic weight gain prevention trial, specifically for Hispanic and Spanish-speaking communities. Future pragmatic trials should consider leveraging in-person recruitment for underrepresented groups in research.

Behavioral treatment for weight gain prevention among black women in primary care practice: a randomized clinical trial.

IMPORTANCE: Few weight loss treatments produce clinically meaningful weight loss outcomes among black women, particularly in the primary care setting. New weight management strategies are necessary for this population. Weight gain prevention might be an effective treatment option, with particular benefits for overweight and class 1 obese black women. OBJECTIVE: To compare changes in weight and cardiometabolic risk during a 12-month period among black women randomized to a primary care-based behavioral weight gain prevention intervention, relative to usual care. DESIGN, SETTING, AND PARTICIPANTS: Two-arm randomized clinical trial (the Shape Program). We recruited patients from a 6-site community health center system. We randomized 194 overweight and class 1 obese (body mass index [calculated as weight in kilograms divided by height in meters squared], 25-34.9) premenopausal black women aged 25 to 44 years. Enrollment began on December 7, 2009; 12- and 18-month assessments were completed in February and October 2, 2012. INTERVENTIONS: The medium-intensity intervention included tailored behavior change goals, weekly self-monitoring via interactive voice response, monthly counseling calls, tailored skills training materials, and a gym membership. MAIN OUTCOMES AND MEASURES: Twelve-month change in weight and body mass index and maintenance of change at 18 months. RESULTS: Participants had a mean age of 35.4 years, a mean weight of 81.1 kg, and a mean body mass index of 30.2 at baseline. Most were socioeconomically disadvantaged (79.7% with educational level less than a college degree; 74.3% reporting annual income <$30,000). The 12-month weight change was larger among intervention participants (mean [SD], -1.0 [0.5] kg), relative to usual care (0.5 [0.5] kg; mean difference, -1.4 kg [95% CI, -2.8 to -0.1 kg]; P = .04). At month 12, 62% of intervention participants were at or below their baseline weights compared with 45% of usual-care participants (P = .03). By 18 months, intervention participants maintained significantly larger changes in weight (mean difference, -1.7 kg; 95% CI, -3.3 to -0.2 kg). CONCLUSIONS AND RELEVANCE: A medium-intensity primary care-based behavioral intervention demonstrated efficacy for weight gain prevention among socioeconomically disadvantaged black women. A "maintain, don't gain" approach might be a useful alternative treatment for reducing obesity-associated disease risk among some premenopausal black women. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00938535.