Finding studies
Finding studies
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Lead
VA Office of Research and Development
1. Objective(s) and Hypotheses: The investigators' 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 obstructive sleep apnea (OSA) and obesity. Secondarily, the investigators will compare additional outcomes between groups including cardiovascular risk scores, sleep symptoms, AHI, well-being, and global ratings of change. The investigators will also conduct an implementation process evaluation informed by the RE-AIM framework to identify predictors and determinants of population uptake of the intervention. 2. Research Design: The investigators plan a hybrid type 1 pragmatic randomized controlled trial assessing effectiveness and an implementation process evaluation. 3. Methodology The investigators will proactively identify patients with OSA and obesity nationwide in VA using data from the CDW (n=696), randomizing patients 1:1 to usual care plus the lifestyle-based weight loss intervention or usual care alone. The investigators will collect primary outcomes at 12 months, but will also collect outcomes at 3 and up to 21 months to assess trends over time. 4. Findings/Progress to Date: Recruitment and outcome collection completed, analysis is ongoing and not yet complete.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
