Lifestyle Intervention for Obstructive Sleep Apnea
(POWER Trial)
Trial Summary
What is the purpose of this trial?
Prevalent obesity related conditions like obstructive sleep apnea (OSA) represent an important opportunity to improve population health. OSA reduces quality of life and is associated with greater risk for cardiovascular disease. Although obesity is the single greatest reversible risk factor for OSA, patients 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. To meet these challenges, the investigators propose a pragmatic trial of proactively offering a remote video-based and self-directed lifestyle-based weight loss intervention with remote coaching to patients with OSA. The investigators primary aim is to test the effectiveness of a proactively delivered and pragmatic lifestyle intervention to improve co-primary endpoints of sleep-related quality of life and weight among patients with 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. Finally, the investigators will also conduct an implementation process evaluation informed by the RE-AIM framework to identify barriers and facilitators to widespread implementation.The investigators will identify patients with OSA and obesity nationwide (n=696) in VA using data from the VA's Corporate Data Warehouse (CDW), and the investigators will contact potentially eligible patients. After confirming eligibility and consent, the investigators will randomly assign subjects to receive the study's lifestyle intervention or usual care alone. The study uses CDW to assess weight change. Subjects will complete questionnaires at baseline at 3, 12 and 21 months after randomization. The lifestyle intervention in POWER focuses on gradual lifestyle behavior change aimed at improving eating habits and increasing physical activity. It encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.
Research Team
Lucas M Donovan, MD MS
Principal Investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Eligibility Criteria
This trial is for individuals with obstructive sleep apnea (OSA) and obesity, having a BMI between 30.0-44.9 kg/m2. Participants should have access to digital media for the intervention and be able to fully engage in study procedures. Those actively in weight loss programs, with certain health conditions or life expectancies under two years, pregnant women, or non-English speakers are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a lifestyle-based weight loss intervention with remote coaching, focusing on gradual lifestyle behavior change aimed at improving eating habits and increasing physical activity.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 12, and 21 months post-randomization.
Implementation Process Evaluation
Conduct an implementation process evaluation informed by the RE-AIM framework to identify barriers and facilitators to widespread implementation.
Treatment Details
Interventions
- Lifestyle Intervention
Lifestyle Intervention is already approved in United States, European Union for the following indications:
- Obesity
- Weight Loss
- Type 2 Diabetes Prevention
- Obesity
- Overweight
- Weight-Related Diseases
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor