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.

"We bleed for our community:" A qualitative exploration of the implementation of a pragmatic weight gain prevention trial from the perspectives of community health center professionals.

BACKGROUND: Clinical 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. METHODS: Participant 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. RESULTS: Eighteen 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. CONCLUSIONS: Results 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 REGISTRATION: This trial was registered with ClinicalTrials.gov (NCT03003403) on December 28, 2016.

Implementation of an At-home Blood Pressure Measurement Protocol in a Hypertension Management Clinical Trial During the COVID-19 Pandemic.

BACKGROUND: The Dietary Approaches to Stop Hypertension eating plan is an evidence-based treatment of hypertension; however, adherence to the Dietary Approaches to Stop Hypertension is low. To improve adherence to the Dietary Approaches to Stop Hypertension among adults with hypertension, we designed Nourish, a 2-arm, 12-month randomized controlled trial. The COVID-19 pandemic necessitated a change from in-person to remotely delivered visits, requiring substantial protocol modifications to measure blood pressure accurately and safely for secondary outcome data. PURPOSE: The purpose of this article is to describe the implementation of an at-home blood pressure measurement protocol for the Nourish trial. CONCLUSION: Our investigator team and study staff developed and implemented a robust and feasible blood pressure measurement protocol to be executed within an at-home format. CLINICAL IMPLICATIONS: The described blood pressure measurement protocol provides a framework for use in future clinical trials and clinical settings in which a remote visit is preferred or required.

Consistent self-monitoring in a commercial app-based intervention for weight loss: results from a randomized trial.

Self-monitoring is the strongest predictor of success in lifestyle interventions for obesity. In this secondary analysis of the GoalTracker trial, we describe outcomes of consistently self-monitoring in a standalone weight loss intervention. The 12-week intervention focused on daily self-monitoring of diet and/or body weight in a commercial app (MyFitnessPal). Participants (N = 100; 21-65 years; BMI 25-45 kg/m2) were categorized as Consistent Trackers if they tracked ≥ 6 out of 7 days for at least 75% of the targeted weeks. One-fourth of participants were Consistent Trackers. This subset was more likely to be married or living with a partner, be non-Hispanic White, and have higher health literacy than Inconsistent Trackers (ps < .05). Consistent tracking was associated with greater weight change than inconsistent tracking at 1 month (mean difference [95% CI] - 1.11 kg [- 2.12, - 0.10]), 3 months (- 2.42 kg [- 3.80, - 1.04]), and 6 months (- 2.13 kg [- 3.99, - 0.27]). Over 3 times as many Consistent Trackers as Inconsistent Trackers achieved ≥ 5% weight loss at 3 months (48 vs. 13%) and at 6 months (54 vs. 15%; ps < .001). Though causality cannot be determined by the present study, tracking weight and/or diet nearly every day per week for 12 weeks in a commercial app may serve as an effective strategy for weight loss. Strategies are needed to promote greater consistency in tracking.

Provider Counseling and Weight Loss Outcomes in a Primary Care-Based Digital Obesity Treatment.

BACKGROUND: Primary care-based digital health weight loss interventions offer promise for addressing obesity in underserved populations. OBJECTIVES: To determine if primary care providers' weight counseling is associated with weight change during a weight loss intervention. DESIGN: This is a secondary analysis of a randomized clinical trial testing a 12-month primary care-based digital health weight loss intervention. PARTICIPANTS: Participants were community health center patients with body mass indexes of 30-44.9 kg/m2. INTERVENTIONS: The weight loss intervention included tailored behavioral goal setting; weekly goal monitoring via text messaging or interactive voice response calls; counseling calls; skills training material; and participant-tailored recommendations for provider counseling. MAIN MEASURES: At 6 and 12 months, participants' weight was measured and they reported if their provider delivered weight counseling (general or intervention-specific) at their most recent visit and their perception of providers' empathy. Providers' documentation of weight counseling was extracted from health records. KEY RESULTS: Participants (n = 134-141) were predominantly female (70%) and African American (55%) with a mean age of 51 years and BMI of 36 kg/m2. Participant-reported provider weight counseling was not associated with weight change. However, participants whose providers documented intervention-specific counseling at any point during the intervention (n = 35) lost 3.1 kg (95% CI 0.4 to 5.7 kg) more than those whose providers documented only general weight counseling (n = 82) and 4.0 kg (95% CI 0.1 to 7.9 kg) more than those whose providers did not document weight counseling (n = 17). Perceptions of provider empathy were associated with greater weight loss from 6 to 12 months (0.8 kg per measure unit, 95% CI 0.07 to 1.5 kg, p = .03). CONCLUSIONS: Provider counseling that focuses specifically on engagement in a weight loss intervention may enhance weight loss outcomes relative to more general weight loss advice. Counseling that enhances patients' perceptions of empathy may be most beneficial for patients' weight loss. TRIAL REGISTRATION: NCT01827800.

The Balance protocol: a pragmatic weight gain prevention randomized controlled trial for medically vulnerable patients within primary care.

BACKGROUND: For patients with obesity who are not ready for or experience barriers to weight loss, clinical practice guidelines recommend provider counseling on preventing further weight gain as a first-line treatment approach. Unfortunately, evidence-based weight gain prevention interventions are not routinely available within primary care. To address this gap, we will implement a pragmatic 12-month randomized controlled trial of a digital weight gain prevention intervention delivered to patients receiving primary care within a network of Federally Qualified Community Health Centers in central North Carolina. METHODS: Balance (Equilibrio in Spanish) is a pragmatic effectiveness trial that will randomize adult patients who have overweight or obesity (BMI of 25-40 kg/m2) to either: 1) a weight gain prevention intervention with tailored behavior change goals and tracking, daily weighing on a network-connected electronic scale, and responsive weight and goal coaching delivered remotely by health center registered dietitians; or 2) a usual care program with automated healthy living text messages and print materials and routine primary care. The primary outcome will be weight gain prevention at 24-months, defined as ≤3% change in baseline weight. To align with its pragmatic design, trial outcome data will be pulled from the electronic health record of the community health center network. DISCUSSION: For underserved, often rurally-located patients with obesity, digital approaches to promote a healthy lifestyle can curb further weight gain. Yet enrolling medically vulnerable patients into a weight gain prevention trial, many of whom are from racial/ethnic minorities, can be difficult. Despite these potential challenges, we plan to recruit a large, diverse sample from rural areas, and will implement a remotely-delivered weight gain prevention intervention to medically vulnerable patients. Upcoming trial results will demonstrate the effectiveness of this pragmatic approach to implement and evaluate a digital weight gain prevention intervention within primary care. TRIALS REGISTRATION: NCT03003403 . Registered December 28, 2016.

A Digital Behavioral Weight Gain Prevention Intervention in Primary Care Practice: Cost and Cost-Effectiveness Analysis.

BACKGROUND: Obesity is one of the largest drivers of health care spending but nearly half of the population with obesity demonstrate suboptimal readiness for weight loss treatment. Black women are disproportionately likely to have both obesity and limited weight loss readiness. However, they have been shown to be receptive to strategies that prevent weight gain. OBJECTIVE: The aim of this study was to evaluate the costs and cost-effectiveness of a digital weight gain prevention intervention (Shape) for black women. Shape consisted of adaptive telephone-based coaching by health system personnel, a tailored skills training curriculum, and patient self-monitoring delivered via a fully automated interactive voice response system. METHODS: A cost and cost-effectiveness analysis based on a randomized clinical trial of the Shape intervention was conducted from the payer perspective. Costs included those of delivering the program to 91 intervention participants in the trial and were summarized by program elements: self-monitoring, skills training, coaching, and administration. Effectiveness was measured in quality-adjusted life years (QALYs). The primary outcome was the incremental cost per QALY of Shape relative to usual care. RESULTS: Shape cost an average of US $758 per participant. The base-case model in which quality of life benefits decay linearly to zero 5 years post intervention cessation, generated an incremental cost-effectiveness ratio (ICER) of US $55,264 per QALY. Probabilistic sensitivity analyses suggest an ICER below US $50,000 per QALY and US $100,000 per QALY in 39% and 98% of simulations, respectively. Results are highly sensitive to durability of benefits, rising to US $165,730 if benefits end 6 months post intervention. CONCLUSIONS: Results suggest that the Shape intervention is cost-effective based on established benchmarks, indicating that it can be a part of a successful strategy to address the nation's growing obesity epidemic in low-income at-risk communities.

Perceived barriers and facilitators of initiation of behavioral weight loss interventions among adults with obesity: a qualitative study.

BACKGROUND: Evidence-based behavioral weight loss interventions are under-utilized. To inform efforts to increase uptake of these interventions, it is important to understand the perspectives of adults with obesity regarding barriers and facilitators of weight loss intervention initiation. METHODS: We conducted a qualitative study in adults with obesity who had recently attempted weight loss either with assistance from an evidence-based behavioral intervention (intervention initiators) or without use of a formal intervention (intervention non-initiators). We recruited primary care patients, members of a commercial weight loss program, and members of a Veterans Affairs weight loss program. Intervention initiators and non-initiators were interviewed separately using a semi-structured interview guide that asked participants about barriers and facilitators of weight loss intervention initiation. Conversations were audio-recorded and transcribed. Data were analyzed with qualitative content analysis. Two researchers used open coding to generate the code book on a subset of transcripts and a single researcher coded remaining transcripts. Codes were combined into subthemes, which were combined in to higher order themes. Intervention initiators and non-initiators were compared. RESULTS: We conducted three focus groups with participants who had initiated interventions (n = 26) and three focus groups (n = 24) and 8 individual interviews with participants who had not initiated interventions. Intervention initiators and non-initiators were, respectively, 65% and 37.5% white, 62% and 63% female, mean age of 55 and 54 years old, and mean BMI of 34 kg/m2. Three themes were identified. One theme was practical factors, with subthemes of reasonable cost and scheduling compatibility. A second theme was anticipated effectiveness of intervention, with subthemes of intervention content addressing individual needs; social aspects influencing effectiveness; and evaluating evidence of effectiveness. A third theme was anticipated pleasantness of intervention, with subthemes of social aspects influencing enjoyment; anticipated dietary and tracking prescriptions; and identity and self-reliance factors. Different perspectives were identified from intervention initiators and non-initiators. CONCLUSIONS: Strategies to engage individuals in evidence-based weight loss interventions can be developed using these results. Strategies could target individuals' perceived barriers and benefits to initiating interventions, or could focus on refining interventions to appeal to more individuals.

Digital Weight Loss Intervention for Parents of Children Being Treated for Obesity: A Prospective Cohort Feasibility Trial.

BACKGROUND: The prevalence of childhood obesity continues to increase, and clinic-based treatment options have failed to demonstrate effectiveness. One of the strongest predictors of child weight is parent weight. Parental treatment for weight loss may indirectly reduce obesity in the child. We have previously demonstrated the effectiveness among adults of a fully automated, evidence-based digital weight loss intervention (Track). However, it is unknown if it is feasible to deliver such a treatment directly to parents with obesity who bring their child with obesity to a weight management clinic for treatment. OBJECTIVE: The objective of our study was to evaluate the feasibility of and engagement with a digital weight loss intervention among parents of children receiving treatment for obesity. METHODS: We conducted a 6-month pre-post feasibility trial among parents or guardians and their children aged 4-16 years presenting for tertiary care obesity treatment. Along with the standard family-based treatment protocol, parents received a 6-month digital weight loss intervention, which included weekly monitoring of personalized behavior change goals via mobile technologies. We examined levels of engagement by tracking completed weeks of self-monitoring and feasibility by assessing change in weight. RESULTS: Participants (N=48) were on average 39 years old, mostly female (35/42, 82% ), non-Hispanic Black individuals (21/41, 51%) with obesity (36/48, 75%). Over a quarter had a yearly household income of

Preventing Weight Gain Improves Sleep Quality Among Black Women: Results from a RCT.

BACKGROUND: Obesity and poor sleep are highly prevalent among Black women. PURPOSE: We examined whether a weight gain prevention intervention improved sleep among Black women. METHODS: We conducted a randomized trial comparing a 12-month weight gain prevention intervention that included self-monitoring through mobile technologies and phone coaching to usual care in community health centers. We measured sleep using the Medical Outcomes Study Sleep Scale at baseline, 12 months, and 18 months. The scale examines quantity of sleep, sleep disturbance, sleep adequacy, daytime somnolence, snoring, shortness of breath, and global sleep problems (sleep problem indices I and II). RESULTS: Participants (n = 184) were on average 35.4 years and obese (BMI 30.2 kg/m2); 74% made <$30,000/year. At baseline, average sleep duration was 6.4 (1.5) hours. Controlling for weight change and sleep medication, the intervention group reported greater improvements in sleep disturbance [-8.35 (-16.24, -0.45)] and sleep problems at 12 months: sleep problem index I [-8.35 (-16.24, -0.45)]; sleep problem index II [-8.35 (-16.24, -0.45)]. However, these findings did not persist at 18 months. CONCLUSIONS: Preventing weight gain may afford clinical benefit on improving sleep quality. TRIAL REGISTRATION NUMBER: The trial was registered with the ClinicalTrials.gov database (NCT00938535).

The effect of a weight gain prevention intervention on moderate-vigorous physical activity among black women: the Shape Program.

BACKGROUND: 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). METHODS: 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). RESULTS: 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). CONCLUSIONS: 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. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov database (No. NCT00938535. Retrospectively Registered 7/10/2009).

Factors related to obesity and overweight among Black adolescent girls in the United States.

In the United States, Black adolescents have the highest prevalence of pediatric obesity and overweight among girls. While Black girls are disproportionately affected, the reasons for this health disparity remain unclear. The authors conducted a systematic review to investigate the factors related to obesity and overweight among Black adolescent girls. The authors searched four databases for relevant English-language publications using all publication years through 2015. Fifty-one studies met the inclusion criteria and were used for this review. Using a configuration approach to synthesis, three categories were identified, paralleling the bioecological theory of human development: (1) individual, (2) interpersonal, and (3) community and societal factors. A description of each factor's association with obesity among Black adolescent girls is presented. From this review, the authors identified a diverse and vast set of individual, interpersonal, and community and societal factors explored for their relationship with obesity and overweight. Given the insufficient repetition and limited significant findings among most factors, the authors believe that multiple gaps in knowledge exist across all categories regarding the factors related to obesity and overweight among Black adolescent girls. To improve the quality of research in this area, suggested research directions and methodological recommendations are provided.

Parent-adolescent influences on everyday dietary practices: Perceptions of adolescent females with obesity and their mothers.

Parents demonstrate an important influence on adolescent obesity and dietary behavior; yet, family-based obesity interventions continue to exhibit limited success among adolescents. To further inform family-based approaches for adolescent obesity treatment, we examined the perceptions of adolescent females with obesity and their mothers of the influences experienced within the parent-adolescent relationship that affect everyday dietary practices. We conducted six focus group interviews (three adolescent female and three mother) among 15 adolescent (12-17 years old) females with obesity and 12 of their mothers. Content analysis techniques were used to analyze the transcribed interviews. Adolescent females with obesity discussed a diverse set of parental influences (controlling, supporting and cultivating, overlooking and tempting, acquiescing, providing, attending, and not providing and avoiding) on their daily dietary practices. Among mother focus groups, mothers discussed specific intentional and unintentional types of influences from children that affected the food and drink they consumed, prepared, and acquired. Findings provide a fuller view of the varied social influences on everyday dietary practices within the parent-adolescent relationship. They indicate the importance of examining both parent-to-child and child-to-parent influences and begin to illuminate the value of attending to the social circumstances surrounding dietary behaviors to strengthen family-based obesity treatment approaches.

Genetic causal attributions for weight status and weight loss during a behavioral weight gain prevention intervention.

PURPOSE: Emerging evidence suggests that attributing one's weight to genetics may contribute to the adoption of obesogenic behaviors. We investigated whether weight-related genetic attributions were associated with weight change during a weight gain prevention intervention. METHODS: Participants (n = 185) were from a randomized clinical trial of a digital health weight gain prevention intervention for black women ages 25-44 years with body mass index 25.0-34.9 kg/m(2). Weight-related genetic attributions (weight status attribution and weight loss attributions) were measured at baseline and 12 months. RESULTS: Among intervention participants, high genetic attribution for weight loss was associated with greater weight loss at 12 months (-2.7 vs. 0.5 kg) and 18 months (-3.0 vs. 0.9 kg). Among usual-care participants, high genetic attribution for weight status was associated with greater 18-month weight gain (2.9 vs. 0.3 kg). The intervention reduced the likelihood of high genetic attribution for weight loss at 12 months (P = 0.05). Change in the likelihood of genetic attribution was not associated with weight change over 12 months. CONCLUSION: Impact of genetic attributions on weight differs for those enrolled and not enrolled in an intervention. However, weight gain prevention intervention may reduce genetic attribution for weight loss.Genet Med 18 5, 476-482.

Health Literacy and Weight Change in a Digital Health Intervention for Women: A Randomized Controlled Trial in Primary Care Practice.

In the United States, 90 million adults have low health literacy. An important public health challenge is developing obesity treatment interventions suitable for those with low health literacy. The objective of this study was to examine differences in sociodemographic and clinical characteristics as well as weight and intervention engagement outcomes by health literacy. We randomized 194 participants to usual care or to the Shape Program intervention, a 12-month digital health treatment aimed at preventing weight gain among overweight and Class I obese Black women in primary care practice. We administered the Newest Vital Sign instrument to assess health literacy. More than half (55%) of participants had low health literacy, which was more common among those with fewer years of education and lower income. There was no effect of health literacy on 12-month weight change or on intervention engagement outcomes (completion of coaching calls and interactive voice response self-monitoring calls). Low health literacy did not preclude successful weight gain prevention in the Shape Program intervention. Goal-focused behavior change approaches like that used in Shape may be particularly helpful for treating and engaging populations with low health literacy.

The effect of a "maintain, don't gain" approach to weight management on depression among black women: results from a randomized controlled trial.

OBJECTIVES: We evaluated the effect of a weight gain prevention intervention (Shape Program) on depression among socioeconomically disadvantaged overweight and obese Black women. METHODS: Between 2009 and 2012, we conducted a randomized trial comparing a 12-month electronic health-based weight gain prevention intervention to usual primary care at 5 central North Carolina community health centers. We assessed depression with the Patient Health Questionnaire (PHQ-8). We analyzed change in depression score from baseline to 12- and 18-month follow-up across groups with mixed models. We used generalized estimating equation models to analyze group differences in the proportion above the clinical threshold for depression (PHQ-8 score ≥ 10). RESULTS: At baseline, 20% of participants reported depression. Twelve-month change in depression scores was larger for intervention participants (mean difference = -1.85; 95% confidence interval = -3.08, -0.61; P = .004). There was a significant reduction in the proportion of intervention participants with depression at 12 months with no change in the usual-care group (11% vs 19%; P = .035). All effects persisted after we controlled for weight change and medication use. We saw similar findings at 18 months. CONCLUSIONS: The Shape Program, which includes no mention of mood, improved depression among socioeconomically disadvantaged Black women.