Obesity, Sleep Apnea, Obstructive
Conditions
Keywords
weight loss, lifestyle, diet, exercise, randomized controlled trial
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.
Detailed 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 and outcome collection completed, analysis is ongoing and not yet complete.
Interventions
BEHAVIORALlifestyle 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
The investigators will randomly assign participants to one of two groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep-related Quality of Life | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Risk Scores | baseline to 12 months post randomization | 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). |
| PROMIS - Sleep Disturbance Survey Change | baseline to 3 months post randomization | 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). |
| PROMIS - Sleep Related Impairment Survey Change | baseline to 3 months post randomization | 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). |
| Systolic Blood Pressure From VA Medical Record | baseline to 12 months post randomization | The investigators will compare change in systolic blood pressure values between intervention and control. |
| Treatment Usage Per Day | baseline to 3 months post randomization | The investigators will compare change in daily OSA treatment usage between groups using self-report. |
| Apnea Hypopnea Index 1b Criteria | 12 months post randomization | 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. |
| Longer-term Change in Weight | baseline to between 18 and 24 months post randomization | The investigators will compare longer-term change in weight between intervention and control using clinic weights from VA medical record |
| Short-term Change in Sleep-related Quality of Life | baseline to 3 months post randomization | 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. |
| Longer-term Change in Sleep-related Quality of Life | baseline to 21 months post randomization | 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. |
| Global Rating of Change | 3 months post randomization | 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". |
| Change in Self-reported Well-being | baseline to 3 months post randomization | 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. |
| Diastolic Blood Pressure From VA Medical Record | baseline to 12 months post randomization | The investigators will compare change in diastolic blood pressure values between intervention and control. |
| Apnea Hypopnea Index 1a Criteria | 12 months post randomization | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLucas M Donovan, MD MS
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 348 |
| Usual Care Control Participants in this arm will continue with usual care without the lifestyle intervention. | 348 |
| Total | 696 |
Baseline characteristics
| Characteristic | Usual Care Control | Lifestyle Intervention | Total |
|---|---|---|---|
| Age, Continuous | 56.38 years STANDARD_DEVIATION 12.38 | 56.03 years STANDARD_DEVIATION 12.03 | 56.20 years STANDARD_DEVIATION 12.2 |
| BMI BMI 30-34.9 | 181 Participants | 186 Participants | 367 Participants |
| BMI BMI 35-44.9 | 167 Participants | 162 Participants | 329 Participants |
| Charlson Co-Morbidity Index | 0.82 units on a scale STANDARD_DEVIATION 1.45 | 0.76 units on a scale STANDARD_DEVIATION 1.49 | 0.79 units on a scale STANDARD_DEVIATION 1.47 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 46 Participants | 39 Participants | 85 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 302 Participants | 308 Participants | 610 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| OSA Severity OSA Severity-mild | 119 Participants | 116 Participants | 235 Participants |
| OSA Severity OSA Severity-moderate to severe | 229 Participants | 232 Participants | 461 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 55 Participants | 65 Participants | 120 Participants |
| Race (NIH/OMB) More than one race | 23 Participants | 29 Participants | 52 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 13 Participants | 24 Participants |
| Race (NIH/OMB) White | 255 Participants | 232 Participants | 487 Participants |
| Rurality/Nonmetropolitan | 55 Participants | 52 Participants | 107 Participants |
| Sex/Gender, Customized Gender, Self-Report Men | 285 Participants | 271 Participants | 556 Participants |
| Sex/Gender, Customized Gender, Self-Report Non-binary | 2 Participants | 1 Participants | 3 Participants |
| Sex/Gender, Customized Gender, Self-Report Women | 61 Participants | 76 Participants | 137 Participants |
| Sleep-related impairment t-score <60 Sleep-related impairment t-score <60 | 161 Participants | 162 Participants | 323 Participants |
| Sleep-related impairment t-score <60 Sleep-related impairment t-score >=60 | 187 Participants | 186 Participants | 373 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 348 | 2 / 348 |
| other Total, other adverse events | 126 / 348 | 127 / 348 |
| serious Total, serious adverse events | 54 / 348 | 40 / 348 |
Outcome results
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.
Time frame: baseline to 12 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Change in Sleep-related Quality of Life | 1.43 units on a scale | Standard Deviation 2.73 |
| Usual Care Control | Change in Sleep-related Quality of Life | 0.93 units on a scale | Standard Deviation 2.89 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: 0.00195% CI: [0.25, 1.04]Mixed Models Analysis
Primary
Change in Weight
The investigators will compare change in weights between intervention and control using clinic weights from VA medical record
Time frame: baseline to between 9 and 15 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Change in Weight | -2.10 kg | Standard Deviation 6.75 |
| Usual Care Control | Change in Weight | -0.88 kg | Standard Deviation 5.86 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: 0.03795% CI: [-2.05, -0.06]Mixed Models Analysis
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.
Time frame: 12 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Apnea Hypopnea Index 1a Criteria | 20.06 events per hour | Standard Deviation 16.05 |
| Usual Care Control | Apnea Hypopnea Index 1a Criteria | 23.23 events per hour | Standard Deviation 19.18 |
Comparison: Linear mixed effects model including each participant's outcome measure, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60).p-value: 0.04195% CI: [-7.11, -0.14]Mixed Models Analysis
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.
Time frame: 12 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Apnea Hypopnea Index 1b Criteria | 13.77 events per hour | Standard Deviation 14.53 |
| Usual Care Control | Apnea Hypopnea Index 1b Criteria | 16.49 events per hour | Standard Deviation 17.73 |
Comparison: Linear mixed effects model including each participant's outcome measure, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60).p-value: 0.06195% CI: [-6.37, 0.15]Mixed Models Analysis
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).
Time frame: baseline to 21 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Cardiovascular Risk Scores | 0.35 score on a scale | Standard Deviation 3.49 |
| Usual Care Control | Cardiovascular Risk Scores | -0.14 score on a scale | Standard Deviation 3.51 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: 0.07495% CI: [-0.04, 0.93]Mixed Models Analysis
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).
Time frame: baseline to 12 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Cardiovascular Risk Scores | 0.22 score on a scale | Standard Deviation 3.47 |
| Usual Care Control | Cardiovascular Risk Scores | -0.20 score on a scale | Standard Deviation 3.65 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: 0.13595% CI: [-0.12, 0.86]Mixed Models Analysis
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.
Time frame: baseline to 12 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Change in Self-reported Well-being | 9.70 units on a scale | Standard Deviation 20.73 |
| Usual Care Control | Change in Self-reported Well-being | 5.50 units on a scale | Standard Deviation 24.14 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: 0.01395% CI: [0.86, 7.27]Mixed Models Analysis
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.
Time frame: baseline to 3 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Change in Self-reported Well-being | 7.76 units on a scale | Standard Deviation 20.92 |
| Usual Care Control | Change in Self-reported Well-being | 3.54 units on a scale | Standard Deviation 19.63 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: 0.01195% CI: [0.91, 6.95]Mixed Models Analysis
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.
Time frame: baseline to 21 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Change in Self-reported Well-being | 7.96 units on a scale | Standard Deviation 21.68 |
| Usual Care Control | Change in Self-reported Well-being | 5.24 units on a scale | Standard Deviation 23.07 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: 0.06595% CI: [-0.2, 6.42]Mixed Models Analysis
Secondary
Diastolic Blood Pressure From VA Medical Record
The investigators will compare change in diastolic blood pressure values between intervention and control.
Time frame: baseline to 21 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Diastolic Blood Pressure From VA Medical Record | 0.13 millimeters of mercury (mmHg) | Standard Deviation 10.42 |
| Usual Care Control | Diastolic Blood Pressure From VA Medical Record | -1.74 millimeters of mercury (mmHg) | Standard Deviation 9.54 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: 0.21295% CI: [-0.58, 2.62]Mixed Models Analysis
Secondary
Diastolic Blood Pressure From VA Medical Record
The investigators will compare change in diastolic blood pressure values between intervention and control.
Time frame: baseline to 12 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Diastolic Blood Pressure From VA Medical Record | -0.30 millimeters of mercury (mm Hg) | Standard Deviation 10.57 |
| Usual Care Control | Diastolic Blood Pressure From VA Medical Record | -1.44 millimeters of mercury (mm Hg) | Standard Deviation 9.78 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: 0.21895% CI: [-0.49, 2.17]Mixed Models Analysis
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.
Time frame: 21 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Global Rating of Change | 2.91 units on a scale | Standard Deviation 1.21 |
| Usual Care Control | Global Rating of Change | 3.10 units on a scale | Standard Deviation 1.23 |
Comparison: Linear mixed effects model including each participant's outcome measure, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60).p-value: 0.10795% CI: [-0.27, 0.03]Mixed Models Analysis
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.
Time frame: 12 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Global Rating of Change | 3.05 units on a scale | Standard Deviation 1.15 |
| Usual Care Control | Global Rating of Change | 3.25 units on a scale | Standard Deviation 1.2 |
Comparison: Linear mixed effects model including each participant's outcome measure, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60).p-value: <0.00195% CI: [-0.44, -0.17]Mixed Models Analysis
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.
Time frame: 3 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Global Rating of Change | 3.29 units on a scale | Standard Deviation 1 |
| Usual Care Control | Global Rating of Change | 3.40 units on a scale | Standard Deviation 1 |
Comparison: Linear mixed effects model including each participant's outcome measure, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60).p-value: 0.11895% CI: [-0.21, 0.02]Mixed Models Analysis
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.
Time frame: baseline to 21 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Longer-term Change in Sleep-related Quality of Life | 1.29 units on a scale | Standard Deviation 3.08 |
| Usual Care Control | Longer-term Change in Sleep-related Quality of Life | 0.96 units on a scale | Standard Deviation 2.89 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: 0.03195% CI: [0.04, 0.89]Mixed Models Analysis
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
Time frame: baseline to between 18 and 24 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Longer-term Change in Weight | -2.64 kg | Standard Deviation 7.71 |
| Usual Care Control | Longer-term Change in Weight | -1.98 kg | Standard Deviation 7.79 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: 0.46995% CI: [-1.69, 0.78]Mixed Models Analysis
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).
Time frame: baseline to 21 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | PROMIS - Sleep Disturbance Survey Change | -3.88 T-score | Standard Deviation 7.75 |
| Usual Care Control | PROMIS - Sleep Disturbance Survey Change | -3.44 T-score | Standard Deviation 8.32 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: 0.22995% CI: [-1.84, 0.44]Mixed Models Analysis
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).
Time frame: baseline to 12 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | PROMIS - Sleep Disturbance Survey Change | -4.53 T-score | Standard Deviation 8.08 |
| Usual Care Control | PROMIS - Sleep Disturbance Survey Change | -3.21 T-score | Standard Deviation 8.01 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: 0.00395% CI: [-2.82, -0.59]Mixed Models Analysis
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).
Time frame: baseline to 3 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | PROMIS - Sleep Disturbance Survey Change | -3.34 T-score | Standard Deviation 7.69 |
| Usual Care Control | PROMIS - Sleep Disturbance Survey Change | -3.02 T-score | Standard Deviation 6.76 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: 0.06895% CI: [-2.01, 0.07]Mixed Models Analysis
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).
Time frame: baseline to 3 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | PROMIS - Sleep Related Impairment Survey Change | -5.67 T-score | Standard Deviation 8.84 |
| Usual Care Control | PROMIS - Sleep Related Impairment Survey Change | -3.13 T-score | Standard Deviation 7.76 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: <0.00195% CI: [-3.83, -1.6]Mixed Models Analysis
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).
Time frame: baseline to 21 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | PROMIS - Sleep Related Impairment Survey Change | -5.78 T-score | Standard Deviation 9.78 |
| Usual Care Control | PROMIS - Sleep Related Impairment Survey Change | -4.76 T-score | Standard Deviation 9.88 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: 0.11695% CI: [-2.3, 0.25]Mixed Models Analysis
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).
Time frame: baseline to 12 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | PROMIS - Sleep Related Impairment Survey Change | -6.33 T-score | Standard Deviation 9.04 |
| Usual Care Control | PROMIS - Sleep Related Impairment Survey Change | -3.96 T-score | Standard Deviation 9.79 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: <0.00195% CI: [-3.72, -1.29]Mixed Models Analysis
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.
Time frame: baseline to 3 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Short-term Change in Sleep-related Quality of Life | 1.30 units on a scale | Standard Deviation 2.34 |
| Usual Care Control | Short-term Change in Sleep-related Quality of Life | 0.67 units on a scale | Standard Deviation 2.35 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: <0.00195% CI: [0.42, 1.13]Mixed Models Analysis
Secondary
Systolic Blood Pressure From VA Medical Record
The investigators will compare change in systolic blood pressure values between intervention and control.
Time frame: baseline to 21 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Systolic Blood Pressure From VA Medical Record | -0.67 millimeters of mercury (mm Hg) | Standard Deviation 15.2 |
| Usual Care Control | Systolic Blood Pressure From VA Medical Record | -2.25 millimeters of mercury (mm Hg) | Standard Deviation 15.1 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: 0.96895% CI: [-2.35, 2.45]Mixed Models Analysis
Secondary
Systolic Blood Pressure From VA Medical Record
The investigators will compare change in systolic blood pressure values between intervention and control.
Time frame: baseline to 12 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Systolic Blood Pressure From VA Medical Record | -0.22 millimeters of mercury (mm Hg) | Standard Deviation 15.73 |
| Usual Care Control | Systolic Blood Pressure From VA Medical Record | -2.26 millimeters of mercury (mm Hg) | Standard Deviation 15.06 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, Charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: 0.40195% CI: [-1.16, 2.89]Mixed Models Analysis
Secondary
Treatment Usage Per Day
The investigators will compare change in daily OSA treatment usage between groups using self-report.
Time frame: baseline to 21 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Treatment Usage Per Day | 1.47 hours of usage | Standard Deviation 3.71 |
| Usual Care Control | Treatment Usage Per Day | 1.23 hours of usage | Standard Deviation 3.95 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: 0.31795% CI: [-0.26, 0.79]Mixed Models Analysis
Secondary
Treatment Usage Per Day
The investigators will compare change in daily OSA treatment usage between groups using self-report.
Time frame: baseline to 3 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Treatment Usage Per Day | 1.04 hours per night | Standard Deviation 2.99 |
| Usual Care Control | Treatment Usage Per Day | 1.58 hours per night | Standard Deviation 3.48 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: 0.03495% CI: [-0.98, -0.04]Mixed Models Analysis
Secondary
Treatment Usage Per Day
The investigators will compare change in daily OSA treatment usage between groups using self-report.
Time frame: baseline to 12 months post randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Treatment Usage Per Day | 1.45 hours of use | Standard Deviation 3.68 |
| Usual Care Control | Treatment Usage Per Day | 1.43 hours of use | Standard Deviation 3.78 |
Comparison: Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.p-value: 0.895% CI: [-0.44, 0.57]Mixed Models Analysis