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IIR 19-422 – HSR Study

IIR 19-422
The EMBER Trial for Weight Management Engagement
Jessica Yelena Breland, PhD MS BA
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, CA
Funding Period: February 2022 - August 2025


Background: Almost 40% of Veterans using the Veterans Health Administration (VA) have obesity, putting millions at risk for costly and debilitating conditions, including diabetes, cancer, and severe COVID-19. VA weight management programs effectively reduce weight, morbidity, and mortality. For example, MOVE!, VA’s flagship program for weight management is associated with reductions in cardiovascular disease and diabetes. However, while 94% of eligible Veterans are offered weight management programs, less than 8% use them. Motivational interviewing improves treatment engagement, but clinicians have limited time to apply it. Therefore, we developed EMBER, a self-directed tool with the goal of Enhancing Motivation for Better Engagement and Reach for weight management. It is available in paper and digital formats. EMBER is not a weight management program, instead it engages Veterans in existing programs by informing and guiding choices about weight management. EMBER is the product of an HSR&D Career Development Award (15-257). Significance: If EMBER increases engagement in effective weight management programs, it has the potential to help Veterans lose weight, thereby improving health and quality of life for thousands of patients. As a result, we address many HSR&D priorities, e.g., access to care, virtual care, healthy equity, & primary care. Innovation & Impact: EMBER is the first self-directed, motivational interviewing-based intervention designed to increase Veteran engagement in weight management programs. As opposed to a “one-off” study in a specific population, the proposed work takes a novel, low-touch population health approach that could be translated to other programs (e.g., behavioral pain management). EMBER also includes vignettes relevant to populations at high risk for obesity (e.g., women, people of color). Further, t he Hybrid Type 1 design will ensure results can be scaled and sustained while also advancing implementation science. As such, the proposed work will: 1) advance the science of engagement in behavioral health programs and 2) facilitate future research on the implementation of EMBER and similar interventions. Specific Aims: 1. Assess whether Veterans randomized to EMBER are more likely to have any weight management engagement at 2-month follow-up (per administrative data supplemented with self-report) compared to those randomized to the control arm (information sheet listing available programs). (Primary Outcome) 2. Assess whether Veterans randomized to EMBER have greater weight management program retention, weight management behaviors (e.g., physical activity), weight loss, and quality of life gains at 6-month follow-up compared to those randomized to the control arm. (Secondary Outcomes) 3. Assess factors likely to affect EMBER’s implementation. Preliminary implementation outcomes will be assessed via RE-AIM4 (Reach, Effectiveness, Implementation) and the Proctor et al.5 implementation outcomes framework (Acceptability, Appropriateness, Costs, Fidelity). (Implementation Outcomes) Randomized two site Hybrid Type 1 Effectiveness-Implementation Trial among Veteran primary care patients with obesity in VA (N=470). Participants will be randomized to EMBER or a control condition consisting of a list of available weight management programs. The primary outcome is any weight management engagement 2-months after baseline. Aims 1 and 2 will use self-report and administrative data to assess intervention outcomes. Aim 3 will use patient data and information from research staff. Methodology: Implementation/Next Steps: If effective, we will use implementation strategies suggested by Aim 3 to ensure Veterans receive EMBER. We will test these strategies in a Hybrid Type 2 trial to understand EMBER’s effectiveness in real world contexts and best practices for dissemination and implementation of EMBER and similar interventions.

External Links for this Project

NIH Reporter

Grant Number: I01HX003082-01A2

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Journal Articles

  1. Breland JY, Fletcher TL, Maguen S, Timko C, Raikov I, Boothroyd DB, Frayne SM. The EMBER trial for weight management engagement: A hybrid type 1 randomized controlled trial protocol. Contemporary clinical trials. 2023 Dec 1; 135:107364. [view]

DRA: Diabetes and Other Endocrine Conditions
DRE: TRL - Applied/Translational
Keywords: Exercise
MeSH Terms: None at this time.

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