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.

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.

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).

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.

Adherence to self-monitoring via interactive voice response technology in an eHealth intervention targeting weight gain prevention among Black women: randomized controlled trial.

BACKGROUND: eHealth interventions are effective for weight control and have the potential for broad reach. Little is known about the use of interactive voice response (IVR) technology for self-monitoring in weight control interventions, particularly among populations disproportionately affected by obesity. OBJECTIVE: This analysis sought to examine patterns and predictors of IVR self-monitoring adherence and the association between adherence and weight change among low-income black women enrolled in a weight gain prevention intervention. METHODS: The Shape Program was a randomized controlled trial comparing a 12-month eHealth behavioral weight gain prevention intervention to usual care among overweight and obese black women in the primary care setting. Intervention participants (n=91) used IVR technology to self-monitor behavior change goals (eg, no sugary drinks, 10,000 steps per day) via weekly IVR calls. Weight data were collected in clinic at baseline, 6, and 12 months. Self-monitoring data was stored in a study database and adherence was operationalized as the percent of weeks with a successful IVR call. RESULTS: Over 12 months, the average IVR completion rate was 71.6% (SD 28.1) and 52% (47/91) had an IVR completion rate ≥80%. At 12 months, IVR call completion was significantly correlated with weight loss (r =-.22; P=.04) and participants with an IVR completion rate ≥80% had significantly greater weight loss compared to those with an IVR completion rate <80% (-1.97 kg, SE 0.67 vs 0.48 kg, SE 0.69; P=.01). Similar outcomes were found for change in body mass index (BMI; mean difference -0.94 kg, 95% CI -1.64 to -0.24; P=.009). Older, more educated participants were more likely to achieve high IVR call completion. Participants reported positive attitudes toward IVR self-monitoring. CONCLUSIONS: Adherence to IVR self-monitoring was high among socioeconomically disadvantaged black women enrolled in a weight gain prevention intervention. Higher adherence to IVR self-monitoring was also associated with greater weight change. IVR is an effective and useful tool to promote self-monitoring and has the potential for widespread use and long-term sustainability. TRIAL REGISTRATION: Clinicaltrials.gov NCT00938535; http://www.clinicaltrials.gov/ct2/show/NCT00938535.

Autism Caregiver Coaching in Africa (ACACIA): Protocol for a type 1-hybrid effectiveness-implementation trial.

BACKGROUND: While early autism intervention can significantly improve outcomes, gaps in implementation exist globally. These gaps are clearest in Africa, where forty percent of the world's children will live by 2050. Task-sharing early intervention to non-specialists is a key implementation strategy, given the lack of specialists in Africa. Naturalistic Developmental Behavioral Interventions (NDBI) are a class of early autism intervention that can be delivered by caregivers. As a foundational step to address the early autism intervention gap, we adapted a non-specialist delivered caregiver coaching NDBI for the South African context, and pre-piloted this cascaded task-sharing approach in an existing system of care. OBJECTIVES: First, we will test the effectiveness of the caregiver coaching NDBI compared to usual care. Second, we will describe coaching implementation factors within the Western Cape Department of Education in South Africa. METHODS: This is a type 1 effectiveness-implementation hybrid design; assessor-blinded, group randomized controlled trial. Participants include 150 autistic children (18-72 months) and their caregivers who live in Cape Town, South Africa, and those involved in intervention implementation. Early Childhood Development practitioners, employed by the Department of Education, will deliver 12, one hour, coaching sessions to the intervention group. The control group will receive usual care. Distal co-primary outcomes include the Communication Domain Standard Score (Vineland Adaptive Behavior Scales, Third Edition) and the Language and Communication Developmental Quotient (Griffiths Scales of Child Development, Third Edition). Proximal secondary outcome include caregiver strategies measured by the sum of five items from the Joint Engagement Rating Inventory. We will describe key implementation determinants. RESULTS: Participant enrolment started in April 2023. Estimated primary completion date is March 2027. CONCLUSION: The ACACIA trial will determine whether a cascaded task-sharing intervention delivered in an educational setting leads to meaningful improvements in communication abilities of autistic children, and identify implementation barriers and facilitators. TRIAL REGISTRATION: NCT05551728 in Clinical Trial Registry (https://clinicaltrials.gov).

Economic analyses of the Be Fit Be Well program: a weight loss program for community health centers.

BACKGROUND: The U.S. Preventive Services Task Force has released new guidelines on obesity, urging primary care physicians to provide obese patients with intensive, multi-component behavioral interventions. However, there are few studies of weight loss in real world nonacademic primary care, and even fewer in largely racial/ethnic minority, low-income samples. OBJECTIVE: To evaluate the recruitment, intervention and replications costs of a 2-year, moderate intensity weight loss and blood pressure control intervention. DESIGN: A comprehensive cost analysis was conducted, associated with a weight loss and hypertension management program delivered in three community health centers as part of a pragmatic randomized trial. PARTICIPANTS: Three hundred and sixty-five high risk, low-income, inner city, minority (71 % were Black/African American and 13 % were Hispanic) patients who were both hypertensive and obese. MAIN MEASURES: Measures included total recruitment costs and intervention costs, cost per participant, and incremental costs per unit reduction in weight and blood pressure. KEY RESULTS: Recruitment and intervention costs were estimated $2,359 per participant for the 2-year program. Compared to the control intervention, the cost per additional kilogram lost was $2,204 /kg, and for blood pressure, $621 /mmHg. Sensitivity analyses suggest that if the program was offered to a larger sample and minor modifications were made, the cost per participant could be reduced to the levels of many commercially available products. CONCLUSIONS: The costs associated with the Be Fit Be Well program were found to be significantly more expensive than many commercially available products, and much higher than the amount that the Centers for Medicare and Medicaid reimburse physicians for obesity counseling. However, given the serious and costly health consequences associated with obesity in high risk, multimorbid and socioeconomically disadvantaged patients, the resources needed to provide interventions like those described here may still prove to be cost-effective with respect to producing long-term behavior change.

Recruitment and retention of participants in a pragmatic randomized intervention trial at three community health clinics: results and lessons learned.

BACKGROUND: Obesity and hypertension and their associated health complications disproportionately affect communities of color and people of lower socioeconomic status. Recruitment and retention of these populations in research trials, and retention in weight loss trials has been an ongoing challenge. METHODS: Be Fit, Be Well was a pragmatic randomized weight loss and hypertension management trial of patients attending one of three community health centers in Boston, Massachusetts. Participants were asked to complete follow-up assessments every 6-months for two years. We describe challenges encountered and strategies implemented to recruit and retain trial participants over the 24-month intervention. We also identify baseline participant characteristics associated with retention status. Retention strategies included financial incentives, contact between assessment visits, building relationships with health center primary care providers (PCPs) and staff, and putting participant convenience first. RESULTS: Active refusal rates were low with 130 of 2,631 patients refusing participation (4.9%). Of 474 eligible persons completing telephone screening, 365 (77.0%) completed their baseline visit and were randomized into the study. The study population was predominantly non-Hispanic Black (71.2%), female (68.5%) and reported annual household income of less than $35,000 (70.1%). Recruitment strategies included use of passive approval of potential participants by PCPs, use of part-time staff, and outsourcing calls to a call center. A total of 314 (86.0%) people completed the 24-month visit. Retention levels varied across study visits and intervention condition. Most participants completed three or more visits (69.6%), with 205 (56.2%) completing all four. At 24-months, lower retention was observed for males and the intervention condition. Retention strategies included building strong relationships with clinic staff, flexibility in overcoming participant barriers through use of taxi vouchers, night and weekend appointments, and keeping participants engaged via newsletters and social gatherings. CONCLUSION: We were able to retain 86.0% of participants at 24-months. Recruitment and retention of high percentages of racial/ethnic minorities and lower income samples is possible with planning, coordination with a trusted community setting and staff (e.g. community health centers and RAs), adaptability and building strong relationships. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT00661817.

Daily text messaging for weight control among racial and ethnic minority women: randomized controlled pilot study.

BACKGROUND: Daily self-monitoring of diet and physical activity behaviors is a strong predictor of weight loss success. Text messaging holds promise as a viable self-monitoring modality, particularly among racial/ethnic minority populations. OBJECTIVE: This pilot study evaluated the feasibility of a text messaging intervention for weight loss among predominantly black women. METHODS: Fifty obese women were randomized to either a 6-month intervention using a fully automated system that included daily text messages for self-monitoring tailored behavioral goals (eg, 10,000 steps per day, no sugary drinks) along with brief feedback and tips (n=26) or to an education control arm (n=24). Weight was objectively measured at baseline and at 6 months. Adherence was defined as the proportion of text messages received in response to self-monitoring prompts. RESULTS: The average daily text messaging adherence rate was 49% (SD 27.9) with 85% (22/26) texting self-monitored behavioral goals 2 or more days per week. Approximately 70% (16/23) strongly agreed that daily texting was easy and helpful and 76% (16/21) felt the frequency of texting was appropriate. At 6 months, the intervention arm lost a mean of 1.27 kg (SD 6.51), and the control arm gained a mean of 1.14 kg (SD 2.53; mean difference -2.41 kg, 95% CI -5.22 to 0.39; P=.09). There was a trend toward greater text messaging adherence being associated with greater percent weight loss (r=-.36; P=.08), but this did not reach statistical significance. There was no significant association between goal attainment and text messaging adherence and no significant predictors of adherence. CONCLUSIONS: Given the increasing penetration of mobile devices, text messaging may be a useful self-monitoring tool for weight control, particularly among populations most in need of intervention. TRIAL REGISTRATION: Clinicaltrials.gov: NCT00939081; http://clinicaltrials.gov/show/NCT00939081 (Archived by WebCite at http://www.webcitation.org/6KiIIcnk1).

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.

Autism Caregiver Coaching in Africa (ACACIA): Protocol for a type 1-hybrid effectiveness-implementation trial.

Background: While early autism intervention can significantly improve outcomes, gaps in implementation exist globally. These gaps are clearest in Africa, where forty percent of the world's children will live by 2050. Task-sharing early intervention to non-specialists is a key implementation strategy, given the lack of specialists in Africa. Naturalistic Developmental Behavioral Interventions (NDBI) are a class of early autism intervention that can be delivered by caregivers. As a foundational step to address the early autism intervention gap, we adapted a non-specialist delivered caregiver coaching NDBI for the South African context, and pre-piloted this cascaded task-sharing approach in an existing system of care. Objectives: First, we will test the effectiveness of the caregiver coaching NDBI compared to usual care. Second, we will describe coaching implementation factors within the Western Cape Department of Education in South Africa. Methods: This is a type 1 effectiveness-implementation hybrid design; assessor-blinded, group randomized controlled trial. Participants include 150 autistic children (18-72 months) and their caregivers who live in Cape Town, South Africa, and those involved in intervention implementation. Early Childhood Development practitioners, employed by the Department of Education, will deliver 12, one hour, coaching sessions to the intervention group. The control group will receive usual care. Distal co-primary outcomes include the Communication Domain Standard Score (Vineland Adaptive Behavior Scales, Third Edition) and the Language and Communication Developmental Quotient (Griffiths Scales of Child Development, Third Edition). Proximal secondary outcome include caregiver strategies measured by the sum of five items from the Joint Engagement Rating Inventory. We will describe key implementation determinants. Results: Participant enrolment started in April 2023. Estimated primary completion date is March 2027. Conclusion: The ACACIA trial will determine whether a cascaded task-sharing intervention delivered in an educational setting leads to meaningful improvements in communication abilities of autistic children, and identify implementation barriers and facilitators.