Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach

Obesity Clinical Trial

— POWER  

Official title:

Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach (POWER)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05104450
• Other study ID #: IIR 20-240
• Secondary ID: I01HX003319
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: August 1, 2025

Study information

• Verified date: June 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

1. 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 completed, continuing outcome collection, no outcomes analyzed yet.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 696
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Apnea
• Obesity
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Weight Loss

Intervention

Behavioral:
• lifestyle intervention
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.

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	cardiovascular risk scores	The investigators will compare change in cardiovascular risk scores between intervention and control using the non-laboratory Framingham algorithm. The minimum value in this risk score is -2, the maximum is 32, and a higher value indicates greater risk of cardiovascular disease (worse outcome).	baseline to 12 months post randomization
Secondary	PROMIS - Sleep Disturbance Survey change	The investigators will compare change in sleep-related disturbance between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey.; The minimum value for PROMIS Sleep Disturbance is a T-score of 28.9, the maximum is a T-score of 76.5, and a greater value indicates greater sleep disturbance (worse outcome).	baseline to 3 months post randomization
Secondary	PROMIS - Sleep Related Impairment Survey change	The investigators will compare change in sleep-related impairment between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Related Impairment Survey.; The minimum value for PROMIS Sleep Related Impairment is a T-score of 30.0, the maximum is a T-score of 80.1, and a greater value indicates greater sleep related impairment (worse outcome).	baseline to 3 months post randomization
Secondary	systolic blood pressure from VA medical record	The investigators will compare change in systolic blood pressure values between intervention and control.	baseline to 12 months post randomization
Secondary	treatment usage per day	The investigators will compare change in daily OSA treatment usage between groups using self-report.	baseline to 3 months post randomization
Secondary	apnea hypopnea index 1b criteria	The investigators will conduct home sleep apnea tests among a subset of patients in each group to compare apnea hypopnea index (a physiologic measure of OSA severity) between groups at 12 months. The apnea hypopnea index measures the number of times per hour of sleep in which an individual stops breathing (apnea) or nearly stops breathing (hypopnea). For this outcome, we will measure apneas and hypopneas using the 1B criteria of the American Academy of Sleep Medicine.	12 months post randomization
Secondary	longer-term change in weight	The investigators will compare longer-term change in weight between intervention and control using clinic weights from VA medical record	baseline to between 18 and 24 months post randomization
Secondary	short-term change in sleep-related quality of life	The investigators will compare short-term change in Functional Outcomes of Sleep questionnaire (FOSQ) between groups. The minimum value of FOSQ is 5, the maximum is 20, and a higher value indicates a better outcome.	baseline to 3 months post randomization
Secondary	longer-term change in sleep-related quality of life	The investigators will compare longer-term change in Functional Outcomes of Sleep questionnaire (FOSQ) between groups. The minimum value of FOSQ is 5, the maximum is 20, and a higher value indicates a better outcome.	baseline to 21 months post randomization
Secondary	Global Rating of Change	The investigators will compare perceived change in symptoms between groups using the single-item patients' global impression of change (PGI-C). PGI-C has been validated in the context of OSA treatment and asks patients to rate symptom changes on a 7 point scale from "1-Very Much Improved" to "7-Very Much Worse".	3 months post randomization
Secondary	change in self-reported well-being	The investigators will compare change in self-reported well-being between groups. Participants will complete a 3-item Well-being signs (WBS) survey asking them to rate the proportion of time they are satisfied, involved, and functioning their best in activities that they value. The minimum value is 0% and the maximum value is 100%, and a higher value on WBS indicates a better outcome.	baseline to 3 months post randomization
Secondary	cardiovascular risk scores	The investigators will compare cardiovascular risk scores between intervention and control using the non-laboratory Framingham algorithm. The minimum value in this risk score is -2, the maximum is 32, and a higher value indicates greater risk of cardiovascular disease (worse outcome).	baseline to 21 months post randomization
Secondary	PROMIS - Sleep Disturbance Survey change	The investigators will compare sleep-related disturbance between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey.; The minimum value for PROMIS Sleep Disturbance is a T-score of 28.9, the maximum is a T-score of 76.5, and a greater value indicates greater sleep disturbance (worse outcome).	baseline to 12 months post randomization
Secondary	PROMIS - Sleep Disturbance Survey change	The investigators will compare sleep-related disturbance between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey.; The minimum value for PROMIS Sleep Disturbance is a T-score of 28.9, the maximum is a T-score of 76.5, and a greater value indicates greater sleep disturbance (worse outcome).	baseline to 21 months post randomization
Secondary	PROMIS - Sleep Related Impairment Survey change	The investigators will compare sleep-related impairment between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Related Impairment Survey.; The minimum value for PROMIS Sleep Related Impairment is a T-score of 30.0, the maximum is a T-score of 80.1, and a greater value indicates greater sleep related impairment (worse outcome).	baseline to 12 months post randomization
Secondary	PROMIS - Sleep Related Impairment Survey change	The investigators will compare sleep-related impairment between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Related Impairment Survey.; The minimum value for PROMIS Sleep Related Impairment is a T-score of 30.0, the maximum is a T-score of 80.1, and a greater value indicates greater sleep related impairment (worse outcome).	baseline to 21 months post randomization
Secondary	systolic blood pressure from VA medical record	The investigators will compare change in systolic blood pressure values between intervention and control.	baseline to 21 months post randomization
Secondary	diastolic blood pressure from VA medical record	The investigators will compare change in diastolic blood pressure values between intervention and control.	baseline to 12 months post randomization
Secondary	diastolic blood pressure from VA medical record	The investigators will compare change in diastolic blood pressure values between intervention and control.	baseline to 21 months post randomization
Secondary	treatment usage per day	The investigators will compare change in daily OSA treatment usage between groups using self-report.	baseline to 12 months post randomization
Secondary	treatment usage per day	The investigators will compare change in daily OSA treatment usage between groups using self-report.	baseline to 21 months post randomization
Secondary	Global Rating of Change	The investigators will compare perceived change in symptoms between groups using the single-item patients' global impression of change (PGI-C). PGI-C has been validated in the context of OSA treatment and asks patients to rate symptom changes on a 7 point scale from "1-Very Much Improved" to "7-Very Much Worse".	12 months post randomization
Secondary	Global Rating of Change	The investigators will compare perceived change in symptoms between groups using the single-item patients' global impression of change (PGI-C). PGI-C has been validated in the context of OSA treatment and asks patients to rate symptom changes on a 7 point scale from "1-Very Much Improved" to "7-Very Much Worse".	21 months post randomization
Secondary	change in self-reported well-being	The investigators will compare change in self-reported well-being between groups. Participants will complete a 3-item Well-being signs (WBS) survey asking them to rate the proportion of time they are satisfied, involved, and functioning their best in activities that they value. The minimum value is 0% and the maximum value is 100%, and a higher value on WBS indicates a better outcome.	baseline to 12 months post randomization
Secondary	change in self-reported well-being	The investigators will compare change in self-reported well-being between groups. Participants will complete a 3-item Well-being signs (WBS) survey asking them to rate the proportion of time they are satisfied, involved, and functioning their best in activities that they value. The minimum value is 0% and the maximum value is 100%, and a higher value on WBS indicates a better outcome.	baseline to 21 months post randomization
Secondary	apnea hypopnea index 1a criteria	The investigators will conduct home sleep apnea tests among a subset of patients in each group to compare apnea hypopnea index (a physiologic measure of OSA severity) between groups at 12 months. The apnea hypopnea index measures the number of times per hour of sleep in which an individual stops breathing (apnea) or nearly stops breathing (hypopnea). For this outcome, we will measure apneas and hypopneas using the 1A criteria of the American Academy of Sleep Medicine.	12 months post randomization