Pragmatic trial of a self-directed intervention for weight loss in obstructive sleep apnea (POWER)

RATIONALE: Self-directed lifestyle interventions may improve access to weight loss care in obstructive sleep apnea (OSA), but effectiveness in routine practice is unknown. OBJECTIVE: Test whether a proactively delivered self-directed lifestyle intervention improves weight and sleep-related quality of life versus usual care. METHODS: POWER enrolled patients with OSA and body mass index of 30-45 kg/m2, recruited from Veteran Affairs (VA) sites nationwide, and randomized participants to a self-directed intervention based on the Diabetes Prevention Program with video-based sessions, readings, and regular coaching reminders or usual care. Co-primary outcomes were change in Functional Outcomes of Sleep Questionnaire (FOSQ) and clinical weight in kilograms (kg) from baseline to 12 months post-randomization. Given two primary outcomes, we defined significance at p = 0.025. MEASUREMENTS AND MAIN RESULTS: This trial randomized 696 participants. Mean age was 56.2 years (SD 12.2), with 19.7% identifying as female. Clinical weights at 12 months were available for 81.9% of intervention and 83.6% of control participants. Unadjusted weight declined 2.1 kg (SD 6.8) in intervention and 0.9 kg (SD 5.9) in control (adjusted between-group difference: -1.1 kg, 95%CI -2.0, -0.1; p = 0.037). FOSQ measures were available at 12 months for 78.2% of intervention and 90.5% of control participants. From baseline to 12 months, unadjusted FOSQ improved 1.4 (SD 2.7) points in intervention and 0.9 (SD 2.9) points in control (adjusted between-group difference: 0.6 points, 95%CI 0.2, 1.0; p = 0.001). CONCLUSION AND RELEVANCE: Among participants with OSA and obesity, a self-directed lifestyle intervention did not improve weight loss and led to improvements in sleep-related quality of life that are of limited clinical importance. TRIAL REGISTRATION: Clinicaltrials.gov NCT05104450, registered 10/19/2021.