Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach (POWER)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 696
- 试验地点
- 2
- 主要终点
- Change in Sleep-related Quality of Life
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
lifestyle intervention
The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.
干预措施: lifestyle intervention (Behavioral)
usual care control
Participants in this arm will continue with usual care without the lifestyle intervention.
结局指标
主要结局
Change in Sleep-related Quality of Life
时间窗: baseline to 12 months post randomization
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.
Change in Weight
时间窗: baseline to between 9 and 15 months post randomization
The investigators will compare change in weights between intervention and control using clinic weights from VA medical record
次要结局
- Global Rating of Change(21 months post randomization)
- Cardiovascular Risk Scores(baseline to 12 months post randomization)
- Cardiovascular Risk Scores(baseline to 21 months post randomization)
- PROMIS - Sleep Disturbance Survey Change(baseline to 21 months post randomization)
- PROMIS - Sleep Related Impairment Survey Change(baseline to 21 months post randomization)
- Systolic Blood Pressure From VA Medical Record(baseline to 21 months post randomization)
- Treatment Usage Per Day(baseline to 21 months post randomization)
- Apnea Hypopnea Index 1b Criteria(12 months post randomization)
- Longer-term Change in Weight(baseline to between 18 and 24 months post randomization)
- Short-term Change in Sleep-related Quality of Life(baseline to 3 months post randomization)
- Longer-term Change in Sleep-related Quality of Life(baseline to 21 months post randomization)
- Global Rating of Change(21 months post randomization)
- Change in Self-reported Well-being(baseline to 21 months post randomization)
- Diastolic Blood Pressure From VA Medical Record(baseline to 21 months post randomization)
- Apnea Hypopnea Index 1a Criteria(12 months post randomization)
