Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach

NCT05104450 | Completed Results DMC

• 2 other identifiers: IIR 20-240I01HX003319
• Study Type: interventional
• Target: 696
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Sleep Apnea, Obstructive

Keywords

weight loss; lifestyle; diet; exercise; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Change in Sleep-related Quality of Life

  The investigators will compare change in Functional Outcomes of Sleep questionnaire (FOSQ) score between groups. The minimum value of FOSQ is 5, the maximum is 20, and a higher value indicates a better outcome.

  baseline to 12 months post randomization

• Change in Weight

  The investigators will compare change in weights between intervention and control using clinic weights from VA medical record

  baseline to between 9 and 15 months post randomization

Secondary Outcomes (26)

• Cardiovascular Risk Scores

  baseline to 12 months post randomization

• PROMIS - Sleep Disturbance Survey Change

  baseline to 3 months post randomization

• PROMIS - Sleep Related Impairment Survey Change

  baseline to 3 months post randomization

• Systolic Blood Pressure From VA Medical Record

  baseline to 12 months post randomization

• Treatment Usage Per Day

  baseline to 3 months post randomization

Study Arms (2)

lifestyle intervention

EXPERIMENTAL

The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.

Behavioral: lifestyle intervention

usual care control

NO INTERVENTION

Participants in this arm will continue with usual care without the lifestyle intervention.

Interventions

lifestyle intervention BEHAVIORAL

Intervention Arm: Usual Care plus a lifestyle behavior change intervention aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention 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.

lifestyle intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of obstructive sleep apnea (OSA) on sleep study (sleep provider confirmed)
• Recent body mass index between 30.0-44.9 kg/m2 and at least one additional plausible BMI in last 12 months
• Access to DVD player, computer, and/or internet
• Able to participate fully in all study protocol/procedures including informed consent

You may not qualify if:

• Inability to speak, read, or understand English
• Recent or active weight loss interventions including use of prescription weight-loss medications, participation in group or individual weight loss programs provided by trained personnel, and prior bariatric surgery or plans for bariatric surgery during the study period.
• Expected weight loss because of alternate explanations such as from illness
• High variability in weight due to fluctuations in volume status (e.g. ascites - liver disease, chronic heart failure)
• Safety and/or adherence concerns due to severe physical or mental health issues, or life expectancy \<24 months
• Pregnant, lactating, or planning to become pregnant during the study period
• Participation in other intervention studies

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

Location

MeSH Terms

Conditions

Obesity; Sleep Apnea, Obstructive; Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Body Weight Changes; Behavior

Results Point of Contact

• Title: Dr. Lucas Donovan
• Organization: Veterans Health Administration

Lucas.Donovan@va.gov

206-277-6783

Study Officials

• Lucas M Donovan, MD MS

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The investigators will randomly assign participants to one of two groups.

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 3, 2021
• Study Start: April 4, 2022
• Primary Completion: August 1, 2024
• Study Completion: May 1, 2025
• Last Updated: October 21, 2025
• Results First Posted: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)