Protocol for a pragmatic trial testing a self-directed lifestyle program targeting weight loss among patients with obstructive sleep apnea (POWER Trial)

Abstract

Background: Obesity comprises the single greatest reversible risk factor for obstructive sleep apnea (OSA). Despite the potential of lifestyle-based weight loss services to improve OSA severity and symptoms, these programs have limited reach. POWER is a pragmatic trial of a remote self-directed weight loss care among patients with OSA.

Methods: POWER randomizes 696 patients with obesity (BMI 30-45 kg/m2) and recent diagnosis or re-confirmation of OSA 1:1 to either a self-directed weight loss intervention or usual care. POWER tests whether such an intervention improves co-primary outcomes of weight and sleep-related quality of life at 12 months. Secondary outcomes include sleep symptoms, global ratings of change, and cardiovascular risk scores. Finally, consistent with a hybrid type 1 approach, the trial embeds an implementation process evaluation. We will use quantitative and qualitative methods including budget impact analyses and qualitative interviews to assess barriers to implementation.

Conclusions: The results of POWER will inform population health approaches to the delivery of weight loss care. A remote self-directed program has the potential to be disseminated widely with limited health system resources and likely low-cost.

Keywords: Lifestyle intervention; Obesity; Obstructive sleep apnea; Population health management.