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| ID | Type | Description | Link |
|---|---|---|---|
| I01HX003319 | U.S. NIH Grant/Contract | View source |
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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.
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.
Research Design:
The investigators plan a hybrid type 1 pragmatic randomized controlled trial assessing effectiveness and an implementation process evaluation.
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.
Findings/Progress to Date:
Recruitment and outcome collection completed, analysis is ongoing and not yet complete.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lifestyle intervention | Experimental | The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care. |
|
| usual care control | No Intervention | Participants in this arm will continue with usual care without the lifestyle intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 1, the maximum is 30%, and a higher value indicates greater risk of cardiovascular disease (worse outcome). | baseline to 12 months post randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucas M Donovan, MD MS | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108-1532 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40590657 | Background | Leonhard AG, Donovan LM. First Steps Toward Implementing Primary Care Obstructive Sleep Apnea Management in Rural West Virginia. Ann Am Thorac Soc. 2025 Jul;22(7):982-983. doi: 10.1513/AnnalsATS.202505-496ED. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lifestyle Intervention | The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care. The lifestyle behavior change intervention is 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. |
| FG001 | Usual Care Control | Participants in this arm will continue with usual care without the lifestyle intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lifestyle Intervention | The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care. The lifestyle behavior change intervention is 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The investigators report here the unadjusted mean changes between baseline and 12 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 12 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | units on a scale | baseline to 12 months post randomization |
|
We systematically collected adverse events (AE) by body system as part of the the 12- and 21-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition. We also systematically reviewed the electronic health record for discharge summaries among all participants at 12 months, and at 21 month follow-up among those who did not complete follow-up surveys.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lifestyle Intervention | The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care. The lifestyle behavior change intervention is 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematological | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematological | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lucas Donovan | Veterans Health Administration | 206-277-6783 | Lucas.Donovan@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 6, 2025 | Jun 3, 2025 | Prot_008.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 12, 2024 | Jun 13, 2024 | SAP_006.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D020181 | Sleep Apnea, Obstructive |
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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The investigators will randomly assign participants to one of two groups.
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| PROMIS - Sleep Disturbance Survey Change | The investigators will compare change in sleep disturbance between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. 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 |
| 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. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 1, the maximum is 30%, and a higher value indicates greater risk of cardiovascular disease (worse outcome). | baseline to 21 months post randomization |
| 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. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. 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 |
| 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. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. 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 |
| 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. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. 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 |
| 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. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| BG001 | Usual Care Control | Participants in this arm will continue with usual care without the lifestyle intervention. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OSA Severity | Using sleep studies performed in usual care, we classified individuals as having either mild or moderate-to-severe obstructive sleep apnea (OSA) based on the documented clinical interpretation of the interpreting physician. If the physician did not describe severity in their impression, we classified individuals with an apnea hypopnea index ≥15 events/hour as being moderate-to-severe and all others as mild. | Count of Participants | Participants |
|
| BMI | BMI (Body Mass Index) defined based on clinical weight and height. We classified individuals into categories defined by 30-34.9 vs. 35-44.9 kg/m2. | Count of Participants | Participants |
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| Sleep-related impairment t-score <60 | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment T-score. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. We classified individuals based on T-score values of ≥ 60 vs. <60. A higher PROMIS T-score represents greater Sleep Related Impairment. | Count of Participants | Participants |
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| Charlson Co-Morbidity Index | Charlson Comorbidity Index (CCI). Individuals receive a score based on their diagnosed comorbidities. These scores range from 0-29. Higher scores indicate a greater mortality risk. | Mean | Standard Deviation | units on a scale |
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| Rurality/Nonmetropolitan | Count of Participants | Participants |
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| OG001 | Usual Care Control | Participants in this arm will continue with usual care without the lifestyle intervention. |
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| Primary | Change in Weight | The investigators will compare change in weights between intervention and control using clinic weights from VA medical record | The investigators report here the unadjusted mean changes between baseline and 9-to-15 month post-randomization follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 9-to-15 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | kg | baseline to between 9 and 15 months post randomization |
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| 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 1, the maximum is 30%, and a higher value indicates greater risk of cardiovascular disease (worse outcome). | The investigators report here the unadjusted mean changes between baseline and 12 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 12 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | score on a scale | baseline to 12 months post randomization |
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| Secondary | PROMIS - Sleep Disturbance Survey Change | The investigators will compare change in sleep disturbance between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. 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). | The investigators report here the unadjusted mean changes between baseline and 3 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 3 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | T-score | baseline to 3 months post randomization |
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| 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. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. 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). | The investigators report here the unadjusted mean changes between baseline and 3 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 3 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | T-score | baseline to 3 months post randomization |
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| Secondary | Systolic Blood Pressure From VA Medical Record | The investigators will compare change in systolic blood pressure values between intervention and control. | The investigators report here the unadjusted mean changes between baseline and 12 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 12 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | millimeters of mercury (mm Hg) | baseline to 12 months post randomization |
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| Secondary | Treatment Usage Per Day | The investigators will compare change in daily OSA treatment usage between groups using self-report. | The investigators report here the unadjusted mean changes between baseline and 3 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 3 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | hours per night | baseline to 3 months post randomization |
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| 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. | The investigators report here the unadjusted means for this outcome. The analysis population for adjusted between-group differences includes participants with available covariate data; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | events per hour | 12 months post randomization |
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| 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 | The investigators report here the unadjusted mean changes between baseline and 18-to-24 month post-randomization follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 18-to-24 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | kg | baseline to between 18 and 24 months post randomization |
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| 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. | The investigators report here the unadjusted mean changes between baseline and 3 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 3 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | units on a scale | baseline to 3 months post randomization |
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| 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. | The investigators report here the unadjusted mean changes between baseline and 21 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 21 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | units on a scale | baseline to 21 months post randomization |
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| 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". | The investigators report here the unadjusted means for this outcome at 3-month follow-up. The analysis population for adjusted between-group differences includes participants with available covariate data; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | units on a scale | 3 months post randomization |
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| 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. | The investigators report here the unadjusted mean changes between baseline and 3 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 3 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | units on a scale | baseline to 3 months post randomization |
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| 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 1, the maximum is 30%, and a higher value indicates greater risk of cardiovascular disease (worse outcome). | The investigators report here the unadjusted mean changes between baseline and 21 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 21 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | score on a scale | baseline to 21 months post randomization |
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| 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. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. 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). | The investigators report here the unadjusted mean changes between baseline and 12 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 12 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | T-score | baseline to 12 months post randomization |
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| 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. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. 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). | The investigators report here the unadjusted mean changes between baseline and 21 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 21 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | T-score | baseline to 21 months post randomization |
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| 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. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. 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). | The investigators report here the unadjusted mean changes between baseline and 12 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 12 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | T-score | baseline to 12 months post randomization |
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| 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. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. 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). | The investigators report here the unadjusted mean changes between baseline and 21 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 21 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | T-score | baseline to 21 months post randomization |
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| Secondary | Systolic Blood Pressure From VA Medical Record | The investigators will compare change in systolic blood pressure values between intervention and control. | The investigators report here the unadjusted mean changes between baseline and 21 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 21 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | millimeters of mercury (mm Hg) | baseline to 21 months post randomization |
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| Secondary | Diastolic Blood Pressure From VA Medical Record | The investigators will compare change in diastolic blood pressure values between intervention and control. | The investigators report here the unadjusted mean changes between baseline and 12 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 12 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | millimeters of mercury (mm Hg) | baseline to 12 months post randomization |
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| Secondary | Diastolic Blood Pressure From VA Medical Record | The investigators will compare change in diastolic blood pressure values between intervention and control. | The investigators report here the unadjusted mean changes between baseline and 21 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 21 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | baseline to 21 months post randomization |
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| Secondary | Treatment Usage Per Day | The investigators will compare change in daily OSA treatment usage between groups using self-report. | The investigators report here the unadjusted mean changes between baseline and 12 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 12 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | hours of use | baseline to 12 months post randomization |
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| Secondary | Treatment Usage Per Day | The investigators will compare change in daily OSA treatment usage between groups using self-report. | The investigators report here the unadjusted mean changes between baseline and 21 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 21 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | hours of usage | baseline to 21 months post randomization |
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| 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". | The investigators report here the unadjusted means for this outcome at 12-month follow-up. The analysis population for adjusted between-group differences includes participants with available covariate data; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | units on a scale | 12 months post randomization |
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| 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". | The investigators report here the unadjusted means for this outcome at 21-month follow-up. The analysis population for adjusted between-group differences includes participants with available covariate data; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | units on a scale | 21 months post randomization |
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| 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. | The investigators report here the unadjusted mean changes between baseline and 12 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 12 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | units on a scale | baseline to 12 months post randomization |
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| 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. | The investigators report here the unadjusted mean changes between baseline and 21 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 21 month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | units on a scale | baseline to 21 months post randomization |
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| 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. | The investigators report here the unadjusted means for this outcome. The analysis population for adjusted between-group differences includes participants with available covariate data; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | events per hour | 12 months post randomization |
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| 1 |
| 348 |
| 54 |
| 348 |
| 126 |
| 348 |
| EG001 | Usual Care Control | Participants in this arm will continue with usual care without the lifestyle intervention. | 2 | 348 | 40 | 348 | 127 | 348 |
| Cardiovascular | Cardiac disorders | Systematic Assessment |
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| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
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| Other | General disorders | Systematic Assessment |
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| Hepatobiliary | Hepatobiliary disorders | Systematic Assessment |
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| Metabolic | Metabolism and nutrition disorders | Systematic Assessment |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neurological | Nervous system disorders | Systematic Assessment |
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| Psychological | Psychiatric disorders | Systematic Assessment |
|
| Renal/Urologic | Renal and urinary disorders | Systematic Assessment |
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| Pulmonary/Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dermatological | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cardiovascular | Cardiac disorders | Systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
| Hepatobiliary | Hepatobiliary disorders | Systematic Assessment |
|
| Metabolic | Metabolism and nutrition disorders | Systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neurological | Nervous system disorders | Systematic Assessment |
|
| Psychological | Psychiatric disorders | Systematic Assessment |
|
| Renal/Urologic | Renal and urinary disorders | Systematic Assessment |
|
| Pulmonary/Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dermatological | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001836 | Body Weight Changes |
| D001519 | Behavior |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom. |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |