Protocol for a prospective, randomized, controlled trial of Mental Contrasting with Implementation Intentions (MCII) to enhance the effectiveness of VA's MOVE! weight management program: WOOP (Wish, Outcome, Obstacle, Plan) VA.

INTRODUCTION: Intensive weight management programs are effective but often have low enrollment and high attrition. Lack of motivation is a key psychological barrier to enrollment, engagement, and weight loss. Mental Contrasting with Implementation Intentions (MCII) is a unique imagery technique that increases motivation for behavior change. We describe our study protocol to assess the efficacy and implementation of MCII to enhance the effectiveness of VA's MOVE! or TeleMOVE! weight management programs using a procedure called "WOOP" (Wish, Outcome, Obstacle, Plan) for Veterans. We hypothesize that WOOP+MOVE! or TeleMOVE! (intervention) will lead to greater MOVE!/TeleMOVE! program engagment and consequently weight loss than MOVE!/TeleMOVE! alone (control). METHOD: Veterans are randomized to either the intervention or control. Both arms receive the either MOVE! or TeleMOVE! weight management programs. The intervention group receives an hour long WOOP training while the control group receives patient education. Both groups receive telephone follow up calls at 3 days, 4 weeks, and 2 months post-baseline. Eligible participants are Veterans (ages 18-70 years) with either obesity (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 25 kg/m2) and an obesity-associated co-morbidity. At baseline, 6 and 12 months, we assess weight, diet, physical activity in both groups. The primary outcome is mean percent weight change at 6 months. Secondary outcomes include changes in waist circumference, diet, physical activity, and dieting self-efficacy and engagement in regular physical activity. We assess implementation using the RE-AIM framework. CONCLUSION: If WOOP VA is found to be efficacious, it will be an important tool to facilitate weight management and improve weight outcomes. CLINICAL TRIAL REGISTRATION: NCT05014984.

Small Practices, Big (QI) Dreams: Customizing Quality Improvement (QI) Efforts for Under-Resourced Primary Care Practices to Improve Diabetes Disparities.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-019-3711-y.

Peer-Led, Remote Intervention to Improve Mental Health Outcomes Using a Holistic, Spirituality-Based Approach: Results from a Pilot Study.

In the United States, Black communities face a complex mental health burden, with growing attention on addressing these disparities through the lens of holistic wellbeing. Given the dearth of research on faith-based interventions focused on mental health through the lens of holistic wellbeing, this study evaluates the impact of a spirituality-based, peer-led one-group pre-test post-test pilot intervention in a sample of Black individuals in the Bronx, New York City. The eight-session creating healthy culture curriculum, focused on improving mental health and spiritual wellbeing, was collaboratively developed through community partnerships. Post-intervention results indicated significantly reduced odds of moderate to severe depression (AOR:0.20), and increased sense of community, social support, role of religion in health, flourishing, and reduced trouble sleeping. In-depth interviews with participants further highlighted the interconnected role between psychosocial and mental health indicators. Findings support importance of holistically developing, implementing, and evaluating spirituality-based mental health interventions in Black communities.

The DREAM Initiative: study protocol for a randomized controlled trial testing an integrated electronic health record and community health worker intervention to promote weight loss among South Asian patients at risk for diabetes.

BACKGROUND: Electronic health record (EHR)-based interventions that use registries and alerts can improve chronic disease care in primary care settings. Community health worker (CHW) interventions also have been shown to improve chronic disease outcomes, especially in minority communities. Despite their potential, these two approaches have not been tested together, including in small primary care practice (PCP) settings. This paper presents the protocol of Diabetes Research, Education, and Action for Minorities (DREAM) Initiative, a 5-year randomized controlled trial integrating both EHR and CHW approaches into a network of PCPs in New York City (NYC) in order to support weight loss efforts among South Asian patients at risk for diabetes. METHODS/DESIGN: The DREAM Initiative was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (National Institutes of Health). A total of 480 individuals at risk for type 2 diabetes will be enrolled into the intervention group, and an equal number will be included in a matched control group. The EHR intervention components include the provision of technical assistance to participating PCPs regarding prediabetes-related registry reports, alerts, and order sets. The CHW intervention components entail group education sessions on diabetes prevention, including weight loss and nutrition. A mixed-methods approach will be used to evaluate the feasibility, adoption, and impact (≥ 5% weight loss) of the integrated study components. Additionally, a cost effectiveness analysis will be conducted using outcomes, implementation costs, and healthcare claims data to determine the incremental cost per person achieving 5% weight loss. DISCUSSION: This study will be the first to test the efficacy of an integrated EHR-CHW intervention within an underserved, minority population and in a practical setting via a network of small PCPs in NYC. The study's implementation is enhanced through cross-sector partnerships, including the local health department, a healthcare payer, and EHR vendors. Through use of a software platform, the study will also systematically track and monitor CHW referrals to social service organizations. Study findings, including those resulting from cost-effectiveness analyses, will have important implications for translating similar strategies to other minority communities in sustainable ways. TRIAL REGISTRATION: This study protocol has been approved and is made available on ClinicalTrials.gov by NCT03188094 as of 15 June 2017.