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.

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.

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.

The Nourish Protocol: A digital health randomized controlled trial to promote the DASH eating pattern among adults with hypertension.

INTRODUCTION: Over 100 million adults in the United States have hypertension. The DASH (Dietary Approaches to Stop Hypertension) eating pattern is an evidence-based first-line treatment option for hypertension; however, adherence to the DASH eating pattern at a population level remains low. To address this gap, we will implement Nourish, a randomized controlled efficacy trial that will leverage a commercially-available smartphone application and evidence-based behavior change principles to improve adherence to the DASH eating pattern among adults with hypertension. METHODS: The Nourish trial is a two-arm, 12-month randomized control trial that will enroll adults (N = 300) with hypertension, defined as a systolic blood pressure of 120-159 mmHg; a diastolic blood pressure of 80-99 mmHg; and/or adults on blood pressure-lowering medication. Nourish will test the efficacy of a digital health intervention, as compared to the attention control arm, on DASH eating pattern adherence and blood pressure. Intervention components will include skills training, self-monitoring, personalized feedback, and responsive coaching. The primary outcome of the trial is 6-month changes in adherence to the DASH eating pattern, as measured by 24-h dietary recalls. DISCUSSION: Millions of Americans remain in need of effective behavioral interventions to manage and improve their hypertension and its adverse consequences. The ubiquity of smartphones offers a promising approach to disseminate the DASH eating pattern. By leveraging these widely used smartphone applications, combined with evidence-based behavior change principles and the DASH eating plan, Nourish will demonstrate the effectiveness of a digital health intervention to improve DASH adherence, and ultimately, to reduce blood pressure. Trial Number: NCT03875.

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.

Lost to Care and Back Again: Patient and Navigator Perspectives on HIV Care Re-engagement.

Engagement in HIV care is critical to achieve viral suppression and ultimately improve health outcomes for people living with HIV (PLWH). However, maintaining their engagement in care is often a challenging goal. Utilizing patient navigators, trained in an adapted ARTAS intervention, to help re-engage out-of-care PLWH has proven to be a valuable resource. This qualitative study describes the encounters between PLWH (n = 11) and their care re-engagement navigators (n = 9). Participants were interviewed in-person; interviews were transcribed and analyzed using the strengths model of case management. PLWH shared how working with navigators increased their motivation to return to HIV care and assisted them to overcome barriers that were a hindrance to care engagement. Navigators described a strengths-based approach to working with their clients, thus helping facilitate PLWH care re-engagement goals and successes. Results from this study may inform the development of effective HIV navigation programs to re-engage out-of-care PLWH, often the hardest-to-engage.

Barriers and Facilitators to Retaining and Reengaging HIV Clients in Care: A Case Study of North Carolina.

Retention in HIV care is critical to decrease disease-related mortality and morbidity and achieve national benchmarks. However, a myriad of barriers and facilitators impact retention in care; these can be understood within the social-ecological model. To elucidate the unique factors that impact consistent HIV care engagement, a qualitative case study was conducted in North Carolina to examine the barriers and facilitators to retain and reengage HIV clients in care. HIV professionals (n = 21) from a variety of health care settings across the state participated in interviews that were transcribed and analyzed for emergent themes. Respondents described barriers to care at all levels within the HIV prevention and care system including intrapersonal, interpersonal, institutional, community, and public policy. Participants also described recent statewide initiatives with the potential to improve care engagement. Results from this study may assist other states with similar challenges to identify needed programs and priorities to optimize client retention in HIV care.

Perspectives from the Field: HIV Testing and Linkage to Care in North Carolina.

BACKGROUND: HIV testing and linkage to care are critical first steps along the care continuum. Targeted efforts are needed in the South to achieve the goals of the National HIV/AIDS Strategy, and qualitative examination of testing and linkage to care from the perspective of professionals in the field can provide nuanced insight into the strengths and limitations of a care system to inform improvement efforts. These issues are explored in North Carolina (NC), with potential applicability to other Southern states. METHODS: Twenty-one interviews were conducted with professionals in the HIV prevention and care systems in NC. Interviews were analyzed for emergent themes. RESULTS: Individuals' access barriers, aspects of clinics and clinical care, challenges for community-based organizations, stigma, and the role of the NC Department of Health and Human Services were identified as themes affecting testing and linkage. DISCUSSION: These findings can inform efforts to address HIV testing and linkage to care in NC. This approach may provide beneficial insight for other systems of care.