Trial Outcomes & Findings for Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach (NCT NCT05104450)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

696 participants

Primary outcome timeframe

baseline to 12 months post randomization

Results posted on

2025-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Usual Care Control Participants in this arm will continue with usual care without the lifestyle intervention.
Overall Study STARTED	348	348
Overall Study COMPLETED	344	345
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Usual Care Control Participants in this arm will continue with usual care without the lifestyle intervention.
Overall Study Death	1	2
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lifestyle Intervention n=348 Participants 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.	Usual Care Control n=348 Participants Participants in this arm will continue with usual care without the lifestyle intervention.	Total n=696 Participants Total of all reporting groups
Age, Continuous	56.03 years STANDARD_DEVIATION 12.03 • n=5 Participants	56.38 years STANDARD_DEVIATION 12.38 • n=7 Participants	56.20 years STANDARD_DEVIATION 12.20 • n=5 Participants
Sex/Gender, Customized Gender, Self-Report · Women	76 Participants n=5 Participants	61 Participants n=7 Participants	137 Participants n=5 Participants
Sex/Gender, Customized Gender, Self-Report · Men	271 Participants n=5 Participants	285 Participants n=7 Participants	556 Participants n=5 Participants
Sex/Gender, Customized Gender, Self-Report · Non-binary	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	39 Participants n=5 Participants	46 Participants n=7 Participants	85 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	308 Participants n=5 Participants	302 Participants n=7 Participants	610 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	65 Participants n=5 Participants	55 Participants n=7 Participants	120 Participants n=5 Participants
Race (NIH/OMB) White	232 Participants n=5 Participants	255 Participants n=7 Participants	487 Participants n=5 Participants
Race (NIH/OMB) More than one race	29 Participants n=5 Participants	23 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
OSA Severity OSA Severity-mild	116 Participants n=5 Participants	119 Participants n=7 Participants	235 Participants n=5 Participants
OSA Severity OSA Severity-moderate to severe	232 Participants n=5 Participants	229 Participants n=7 Participants	461 Participants n=5 Participants
BMI BMI 30-34.9	186 Participants n=5 Participants	181 Participants n=7 Participants	367 Participants n=5 Participants
BMI BMI 35-44.9	162 Participants n=5 Participants	167 Participants n=7 Participants	329 Participants n=5 Participants
Sleep-related impairment t-score <60 Sleep-related impairment t-score <60	162 Participants n=5 Participants	161 Participants n=7 Participants	323 Participants n=5 Participants
Sleep-related impairment t-score <60 Sleep-related impairment t-score >=60	186 Participants n=5 Participants	187 Participants n=7 Participants	373 Participants n=5 Participants
Charlson Co-Morbidity Index	0.76 units on a scale STANDARD_DEVIATION 1.49 • n=5 Participants	0.82 units on a scale STANDARD_DEVIATION 1.45 • n=7 Participants	0.79 units on a scale STANDARD_DEVIATION 1.47 • n=5 Participants
Rurality/Nonmetropolitan	52 Participants n=5 Participants	55 Participants n=7 Participants	107 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=272 Participants 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.	Usual Care Control n=315 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Change in Sleep-related Quality of Life	1.43 units on a scale Standard Deviation 2.73	0.93 units on a scale Standard Deviation 2.89

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=285 Participants 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.	Usual Care Control n=291 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Change in Weight	-2.10 kg Standard Deviation 6.75	-0.88 kg Standard Deviation 5.86

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=346 Participants 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.	Usual Care Control n=347 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Cardiovascular Risk Scores	0.22 score on a scale Standard Deviation 3.47	-0.20 score on a scale Standard Deviation 3.65

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=241 Participants 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.	Usual Care Control n=304 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
PROMIS - Sleep Disturbance Survey Change	-3.34 T-score Standard Deviation 7.69	-3.02 T-score Standard Deviation 6.76

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=242 Participants 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.	Usual Care Control n=306 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
PROMIS - Sleep Related Impairment Survey Change	-5.67 T-score Standard Deviation 8.84	-3.13 T-score Standard Deviation 7.76

SECONDARY outcome

Timeframe: 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.

The investigators will compare change in systolic blood pressure values between intervention and control.

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=291 Participants 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.	Usual Care Control n=295 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Systolic Blood Pressure From VA Medical Record	-0.22 millimeters of mercury (mm Hg) Standard Deviation 15.73	-2.26 millimeters of mercury (mm Hg) Standard Deviation 15.06

SECONDARY outcome

Timeframe: 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.

The investigators will compare change in daily OSA treatment usage between groups using self-report.

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=239 Participants 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.	Usual Care Control n=300 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Treatment Usage Per Day	1.04 hours per night Standard Deviation 2.99	1.58 hours per night Standard Deviation 3.48

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=79 Participants 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.	Usual Care Control n=103 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Apnea Hypopnea Index 1b Criteria	13.77 events per hour Standard Deviation 14.53	16.49 events per hour Standard Deviation 17.73

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=260 Participants 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.	Usual Care Control n=274 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Longer-term Change in Weight	-2.64 kg Standard Deviation 7.71	-1.98 kg Standard Deviation 7.79

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=247 Participants 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.	Usual Care Control n=310 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Short-term Change in Sleep-related Quality of Life	1.30 units on a scale Standard Deviation 2.34	0.67 units on a scale Standard Deviation 2.35

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=249 Participants 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.	Usual Care Control n=302 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Longer-term Change in Sleep-related Quality of Life	1.29 units on a scale Standard Deviation 3.08	0.96 units on a scale Standard Deviation 2.89

SECONDARY outcome

Timeframe: 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.

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".

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=240 Participants 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.	Usual Care Control n=300 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Global Rating of Change	3.29 units on a scale Standard Deviation 1.00	3.40 units on a scale Standard Deviation 1.00

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=240 Participants 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.	Usual Care Control n=302 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Change in Self-reported Well-being	7.76 units on a scale Standard Deviation 20.92	3.54 units on a scale Standard Deviation 19.63

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=344 Participants 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.	Usual Care Control n=345 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Cardiovascular Risk Scores	0.35 score on a scale Standard Deviation 3.49	-0.14 score on a scale Standard Deviation 3.51

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=263 Participants 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.	Usual Care Control n=301 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
PROMIS - Sleep Disturbance Survey Change	-4.53 T-score Standard Deviation 8.08	-3.21 T-score Standard Deviation 8.01

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=238 Participants 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.	Usual Care Control n=293 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
PROMIS - Sleep Disturbance Survey Change	-3.88 T-score Standard Deviation 7.75	-3.44 T-score Standard Deviation 8.32

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=263 Participants 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.	Usual Care Control n=303 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
PROMIS - Sleep Related Impairment Survey Change	-6.33 T-score Standard Deviation 9.04	-3.96 T-score Standard Deviation 9.79

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=238 Participants 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.	Usual Care Control n=294 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
PROMIS - Sleep Related Impairment Survey Change	-5.78 T-score Standard Deviation 9.78	-4.76 T-score Standard Deviation 9.88

SECONDARY outcome

Timeframe: 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.

The investigators will compare change in systolic blood pressure values between intervention and control.

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=210 Participants 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.	Usual Care Control n=209 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Systolic Blood Pressure From VA Medical Record	-0.67 millimeters of mercury (mm Hg) Standard Deviation 15.20	-2.25 millimeters of mercury (mm Hg) Standard Deviation 15.10

SECONDARY outcome

Timeframe: 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.

The investigators will compare change in diastolic blood pressure values between intervention and control.

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=291 Participants 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.	Usual Care Control n=295 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Diastolic Blood Pressure From VA Medical Record	-0.30 millimeters of mercury (mm Hg) Standard Deviation 10.57	-1.44 millimeters of mercury (mm Hg) Standard Deviation 9.78

SECONDARY outcome

Timeframe: 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.

The investigators will compare change in diastolic blood pressure values between intervention and control.

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=210 Participants 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.	Usual Care Control n=209 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Diastolic Blood Pressure From VA Medical Record	0.13 millimeters of mercury (mmHg) Standard Deviation 10.42	-1.74 millimeters of mercury (mmHg) Standard Deviation 9.54

SECONDARY outcome

Timeframe: 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.

The investigators will compare change in daily OSA treatment usage between groups using self-report.

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=259 Participants 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.	Usual Care Control n=303 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Treatment Usage Per Day	1.45 hours of use Standard Deviation 3.68	1.43 hours of use Standard Deviation 3.78

SECONDARY outcome

Timeframe: 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.

The investigators will compare change in daily OSA treatment usage between groups using self-report.

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=235 Participants 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.	Usual Care Control n=290 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Treatment Usage Per Day	1.47 hours of usage Standard Deviation 3.71	1.23 hours of usage Standard Deviation 3.95

SECONDARY outcome

Timeframe: 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.

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".

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=262 Participants 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.	Usual Care Control n=304 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Global Rating of Change	3.05 units on a scale Standard Deviation 1.15	3.25 units on a scale Standard Deviation 1.20

SECONDARY outcome

Timeframe: 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.

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".

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=233 Participants 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.	Usual Care Control n=293 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Global Rating of Change	2.91 units on a scale Standard Deviation 1.21	3.10 units on a scale Standard Deviation 1.23

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=263 Participants 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.	Usual Care Control n=303 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Change in Self-reported Well-being	9.70 units on a scale Standard Deviation 20.73	5.50 units on a scale Standard Deviation 24.14

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=234 Participants 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.	Usual Care Control n=293 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Change in Self-reported Well-being	7.96 units on a scale Standard Deviation 21.68	5.24 units on a scale Standard Deviation 23.07

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=79 Participants 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.	Usual Care Control n=103 Participants Participants in this arm will continue with usual care without the lifestyle intervention.
Apnea Hypopnea Index 1a Criteria	20.06 events per hour Standard Deviation 16.05	23.23 events per hour Standard Deviation 19.18

Adverse Events

Lifestyle Intervention

Serious events: 54 serious events

Other events: 126 other events

Deaths: 1 deaths

Usual Care Control

Serious events: 40 serious events

Other events: 127 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Lifestyle Intervention n=348 participants at risk 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.	Usual Care Control n=348 participants at risk Participants in this arm will continue with usual care without the lifestyle intervention.
Blood and lymphatic system disorders Hematological	1.4% 5/348 • 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.	1.1% 4/348 • 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.
Cardiac disorders Cardiovascular	4.9% 17/348 • 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.	6.0% 21/348 • 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.
Gastrointestinal disorders Gastrointestinal	2.9% 10/348 • 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.	1.7% 6/348 • 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.
General disorders Other	1.4% 5/348 • 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.	0.57% 2/348 • 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.
Hepatobiliary disorders Hepatobiliary	0.86% 3/348 • 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.	0.00% 0/348 • 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.
Metabolism and nutrition disorders Metabolic	0.57% 2/348 • 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.	0.86% 3/348 • 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.
Musculoskeletal and connective tissue disorders Musculoskeletal	2.9% 10/348 • 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.	2.0% 7/348 • 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.
Nervous system disorders Neurological	2.6% 9/348 • 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.	0.57% 2/348 • 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.
Psychiatric disorders Psychological	1.1% 4/348 • 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.	0.86% 3/348 • 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.
Renal and urinary disorders Renal/Urologic	1.7% 6/348 • 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.	1.4% 5/348 • 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.
Respiratory, thoracic and mediastinal disorders Pulmonary/Respiratory	2.0% 7/348 • 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.	2.0% 7/348 • 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.
Skin and subcutaneous tissue disorders Dermatological	0.29% 1/348 • 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.	0.00% 0/348 • 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.

Other adverse events

Other adverse events
Measure	Lifestyle Intervention n=348 participants at risk 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.	Usual Care Control n=348 participants at risk Participants in this arm will continue with usual care without the lifestyle intervention.
Blood and lymphatic system disorders Hematological	0.29% 1/348 • 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.	0.29% 1/348 • 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.
Cardiac disorders Cardiovascular	6.0% 21/348 • 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.	3.7% 13/348 • 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.
Gastrointestinal disorders Gastrointestinal	6.0% 21/348 • 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.	6.0% 21/348 • 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.
General disorders Other	6.0% 21/348 • 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.	5.2% 18/348 • 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.
Hepatobiliary disorders Hepatobiliary	0.57% 2/348 • 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.	0.86% 3/348 • 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.
Metabolism and nutrition disorders Metabolic	1.1% 4/348 • 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.	1.1% 4/348 • 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.
Musculoskeletal and connective tissue disorders Musculoskeletal	18.1% 63/348 • 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.	15.5% 54/348 • 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.
Nervous system disorders Neurological	3.7% 13/348 • 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.	3.4% 12/348 • 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.
Psychiatric disorders Psychological	3.2% 11/348 • 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.	1.7% 6/348 • 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.
Renal and urinary disorders Renal/Urologic	2.0% 7/348 • 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.	4.3% 15/348 • 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.
Respiratory, thoracic and mediastinal disorders Pulmonary/Respiratory	6.0% 21/348 • 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.	3.4% 12/348 • 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.
Skin and subcutaneous tissue disorders Dermatological	2.9% 10/348 • 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.	3.7% 13/348 • 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.

Additional Information

Dr. Lucas Donovan

Veterans Health Administration

Phone: 206-277-6783

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place