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IIR 20-240 – HSR&D Study

 
IIR 20-240
Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach (POWER)
Lucas M Donovan MD MS
Seattle, WA
Funding Period: October 2021 - September 2025

Abstract

Background: Prevalent obesity related conditions like obstructive sleep apnea (OSA) represent an important opportunity for the VA to improve population health. OSA markedly reduces quality of life and is associated with 3-fold greater risk for cardiovascular disease. Although obesity is the single greatest reversible risk factor for OSA, the 1 million Veterans with OSA and obesity rarely receive weight loss care to reverse OSA and other serious comorbidities. Efficacy trials reinforce that time and resource intensive lifestyle-based weight loss programs improve weight and physiologic measures of OSA severity (apnea hypopnea index, AHI). However, there are barriers to translating these findings into meaningful gains for population health. First, VA has limited capacity to counsel patients around lifestyle change. Less than one-third of Veterans with OSA and obesity are counseled about weight loss and even fewer are referred to weight loss services. Second, VA’s current weight loss offerings are difficult to access. Only 12% of Veterans with OSA and obesity utilize MOVE!, and those referred to MOVE! achieve minimal weight loss—1.2 kg at 1 year. Third, prior weight loss trials focused on intermediate measures (e.g. AHI), limiting understanding of effectiveness for meaningful outcomes. To meet these challenges, we propose a pragmatic trial of proactively offering a remote video-based and self-directed weight loss intervention with telephone-based coaching to Veterans with newly diagnosed OSA. Our weight loss intervention (D-ELITE) is adapted from a program known to be effective in a non-VA population, with 44% of participants achieving ≥5% weight loss at 24 months. Further optimizing reach, our remote intervention includes low-technology options (e.g. DVD videos) to accommodate those with low technology literacy. Significance: Our research tests a program of proactively providing Veterans with OSA the tools to manage weight loss in a way that is independent of local provider time and resources. Our research addresses a key gap in Veteran’s health in a way that aligns with important VA priorities including population health, virtual care, access, and health care value. We anticipate our intervention can efficiently achieve improvements in quality of life while reducing the burden and risk of serious comorbidities. Innovation and Impact: Our research directly challenges the traditional provider-driven model of healthcare delivery where providers direct care and provide necessary services aimed at managing a single disease. Instead, we propose to proactively deliver weight loss services to a high-risk group using a population health approach. In doing so, we will conduct the first trial of remote and self-directed weight loss care in OSA and will test whether weight loss care can improve meaningful outcomes such as quality of life and cardiovascular risk. Specific Aims: Our primary aim is to test the effectiveness of a proactively delivered and pragmatic weight loss intervention to improve co-primary endpoints of sleep-related quality of life and weight among Veterans with OSA and obesity. Secondarily, we will compare additional outcomes between groups: cardiovascular risk scores, sleep symptoms, and AHI. Finally, we will also conduct an implementation process evaluation informed by the RE-AIM framework to identify barriers and facilitators to widespread implementation. Methodology: We plan a hybrid type 1 pragmatic randomized controlled trial. We will proactively identify Veterans with OSA and obesity nationwide using data from the CDW (n=696), randomizing 1:1 to usual care plus the D-ELITE weight loss intervention or usual care alone. We will collect primary outcomes at 12 months, but we will also collect outcomes at 3 and 24 months to assess trends over time. We will use quantitative and qualitative methods to assess barriers to implementation, including a comprehensive budget impact analysis. Next Steps/Implementation: If effective, we will work with our operational partner, the National Center for Health Promotion and Prevention (NCP), to integrate D-ELITE into NCPs suite of weight loss offerings. The National Program Office for Pulmonary/Sleep also agrees to promote policies supporting nationwide adoption.

External Links for this Project

NIH Reporter

Grant Number: I01HX003319-01A1
Link: https://reporter.nih.gov/project-details/10311958



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PUBLICATIONS:

None at this time.

DRA: Other Conditions
DRE: Treatment - Observational, TRL - Applied/Translational
Keywords: Comparative Effectiveness
MeSH Terms: None at this time.

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