Testing a novel Weight Navigation Program to overcome multilevel barriers to obesity treatment in primary care settings - Many weight management treatment options can support weight loss among individuals with obesity (e.g., lifestyle interventions, anti-obesity medications, bariatric surgery), but all are underutilized, and few patients (<15%) achieve and/or maintain clinically-relevant weight loss of ≥ 5%. This is due, in part, to obesity treatment barriers faced by primary care providers (PCPs) and their practices. Such barriers include (1) PCPs' lack of training in obesity medicine; (2) short clinic visits with multiple competing priorities; (3) limited capacity for frequent follow-up visits; and (4) absent strategies to proactively identify and support patients with < 5% weight loss. The overall aim of this proposal is to test a novel Weight Navigation Program (WNP) with components tailored to overcome these PCP- and practice-level barriers. Specifically, the WNP draws on principles of team-based, collaborative care and population health management to (1) enhance patients’ access to effective, preference-sensitive weight-loss treatment options through weight-focused consultation visits with obesity medicine experts, and to (2) optimize patients’ achievement of ≥ 5% weight loss through use of remote weight monitoring tools to proactively identify and support early weight loss non-responders (e.g., <3% weight loss at 12 weeks). During a 12-month pilot evaluation period, the WNP demonstrated feasibility and acceptability among patients and providers, and WNP participants (n=135) were nearly twice as likely to achieve ≥ 5% weight loss as compared to a contemporaneous matched control group from a neighboring primary care clinic. We now propose to conduct a 12-month hybrid type 1, pragmatic, randomized controlled trial to evaluate the WNP's weight loss effectiveness and implementation among primary care patients with obesity, defined as BMI ≥ 30 kg/2 (n=500). The specific aims of this study are to: (1) Compare the effectiveness of WNP versus Enhanced Usual Care (EUC) on the primary outcome of mean weight loss at 12 months; (2) Evaluate processes and determinants of successful WNP implementation using the RE-AIM framework and the Tailored Implementation of Chronic Diseases (TICD) checklist; and (3) Refine the WNP using tailored strategies that address key barriers to implementation. Key implementation outcomes include feasibility, acceptability, appropriateness, fidelity, and cost. This proposal has multiple innovations, including its use of multilevel strategies to surmount PCP- and practice-level barriers to obesity treatment, its focus on augmenting preference-sensitive use of existing obesity treatments, and its strong scientific rationale for and real-world approach to identifying and supporting early weight loss non-responders. We anticipate our WNP model will offer a scalable and sustainable approach to shift the paradigm in primary care-based weight management treatment and successfully support weight loss and improved health among patients with obesity. This directly advances NIDDK’s mission to support the research necessary to “combat the many debilitating and costly chronic diseases” and “improve people’s health and quality of life.”
