The EMBER trial for weight management engagement: a hybrid type 1 randomized controlled trial protocol
Abstract: Background: Almost 40% of Veterans Health Administration (VHA) users have obesity. VHA's national weight management program is associated with weight loss and improved health. However, while 94% of eligible VHA users are offered weight management programs, <8% use them. We developed EMBER - a novel, Motivational Interviewing-based, self-help tool - with the goal of Enhancing Motivation for Better Engagement and Reach for weight management. EMBER is not a weight management program; instead it engages people in existing programs by informing and guiding choices about weight management. Methods: The EMBER Trial is a randomized hybrid type 1 effectiveness implementation trial. Participants are Palo Alto or Houston VA Health Care System users with obesity who have not used a VHA weight management program in the past two years (target N = 470). Participants are randomly assigned to EMBER or an information-only control condition, after which they receive materials on paper or digitally, per their preference. The trial's primary goal is to determine whether Participants randomized to EMBER are more likely to have any weight management engagement at two-month follow-up compared to those in the control condition. Secondary outcomes include 6-month retention in weight management, weight management behaviors, weight loss, quality of life, and implementation outcomes (e.g., reach, appropriateness). Conclusion: EMBER is the first self-directed, Motivational Interviewing-based intervention designed to increase weight management program engagement. The study takes a low-touch, population health approach that could be modified for other programs if effective. The Hybrid Type 1 design will ensure Results can be scaled and sustained.