Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach (POWER)
Phase: NA
Conditions: Obesity, Sleep Apnea, Obstructive
Sponsor: VA Office of Research and Development

1 I01 HX003319-01A1
Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and 
Reach (POWER)
Funding Agency: HSR&D
Principal Investigator: Lucas M. Donovan, MD MS
March 04, 2025
Version 2.19
 
VA Puget Sound IRB 2
Effective Date:
March 6, 2025

Summary of Edits:
 
Version 1.1, 8.03.2021:

List of Abbreviations: Updated
5.0 Study Procedures

Added JLV and Capri throughout this section as additional potential data sources
Version 1.2, 9.09.2021:
5.5.3 Secondary Effectiveness Outcomes:

Added “global impression of change” measure and description
Version 1.3, 10.06.2021:

Added summary of Edits section

Added footer to include filename date and version number

Updated Study Personnel-removed Peter Rise and Added Anna Pannick
Version 2.0, 11.26.2021:
Updates throughout protocol:

Added USB as a mode for intervention course videos

Added Qualtrics, online, and email as additional modes throughout protocol

Corrected grammar and formatting throughout

Replaced ‘D-ELITE’ with “lifestyle intervention” 

Removed guaranteed use of ANNIE texting
Abstract
o
Removed abstract template instructions
Section 2.0 Introduction
o
Corrected some grammar and updated cost of videos and added videos via USB
o
Reformatted, renamed, and/or moved tables and figures
Section 5.0 Study Procedures

Added 5.3.4 Stratification section

Added 5.3.6. Participant compensation section

Added Qualtrics, online, and email for recruitment and survey administration
5.3.2. Medical Clearance 

Added sleep provider contact
5.3.3. Randomization
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
Updated Lifestyle Coach training with current provider of training/certification: SparkPro
5.3.7 Participant compensation

Added qualitative interview payment
5.4 Inclusion/Exclusion Criteria 

Changed the inclusion criteria of OSA to sleep provider confirmed

Edited Table 5: Measures and timing of collection to include missing secondary outcomes
5.5.1 Baseline and follow-up effectiveness measures and data collection

Added “global impression of change”
5.5.7.2 Data Collection for Qualitative Evaluations of Implementation Process

Replaced audiotaping orientations with auditing

Removed guaranteed use of ‘clockify’

Renamed section to distinguish from analysis 
5.5.7.3 Data Collection for Quantitative Evaluations of Implementation Process

Renamed section to distinguish from analysis

Revised content for clarity
5.6.2 Hypothesis Testing for Analysis of Trial Population

Edited analysis precision variables to reflect new stratified randomization covariates
5.6.4 Analysis for Qualitative and Quantitative Evaluations of Implementation Process

Merged former separate quantitative and qualitative sections

Renamed section to distinguish from data collection

Revised content for clarity
6.1 Safety Assessment

Generalized investigator(s) assessing AEs
7.0 Privacy and Confidentiality

Added info re: option to answer questionaries online via Qualtrics

Added info re: contact information shared with contracted sleep study company 
9.0 Information Security and Data Storage/Movement

Added info re: type of information shared with Qualtrics

Added info re: how Qualtrics data will be stored in SQL database

Added info re: transferring data from a contracted company performing home sleep apnea 
testing
Version 2.1, 01/18/2022:
Updates throughout protocol: 

Corrected grammar and formatting 
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
Removed “random” or “randomized” description for sleep study 
1.0 Study Personnel 

Added Travis Hee Wai 
5.2.5 Research Invitation 

Added contingency plans for completing screening survey 
5.3.2 Medical Clearance 

Updated asking clearance from sleep specialist for a single night 
5.3.3 Randomization 

Added that participants may be notified of randomization via email
5.5.1 Baseline and follow-up effectiveness measures and data collection 

Added Qualtrics survey adaptations 
5.5.2 Primary Outcomes 

Included validation response for weights reported in Qualtrics 
5.5.6 Physiologic OSA Severity

Removed the sleep study from baseline. Increased n=100 to n=200 per arm at 12 months. 
Version 2.2, 02/18/2022:
Updates throughout protocol: 

Removed gender as a stratification variable, reducing the total strata from 16 to 8 
Table 5: Measures and timing of collection

Increased n=200 to n=400 for total HSAT collection. 
7.0 Privacy and Confidentiality 

Added info re: incoming emails or text messages to the POWER inbox

Added info re: outgoing text messages
5.2.5 Research Invitation 

Removed Qualtrics screening survey 
5.3.7 Participant compensation

Added sleep study participation as a qualifier for compensation
5.6.2. Hypothesis Testing for Analyses of Trial Population

Modified models for testing our hypotheses 
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5.6.3. Missing and Misclassified Data
Added more practices for missingness 
Table 4: Inclusion and Exclusion Criteria 

Added participation in other intervention studies and inability to speak, read, or understand 
English under exclusion criteria
Version 2.3, 03/18/22
5.2.6. Recruitment of Lifestyle Coaches for Interviews

Removed qualitative interview-specific information statement

Edited language to reflect future modifications
5.4 Inclusion/Exclusion Criteria 

Modified reviewing sleep studies to include those that have not opted out
5.5.7.2. Data Collection for Qualitative Evaluation of Implementation Process

Removed “by phone” as mode for all interviews to allow for more flexibility in interviewing, 
particularly with the lifestyle coach interviews.
Version 2.4, 06/03/22
Updated study staff-remove Tanya Nguyen
5.5.7.3. Data Collection for Quantitative Evaluations of Implementation Process

Changes to REACH, EFFECTIVENESS, and Maintenance subsection defining REACH 
and how we will query EHR 
Version 2.5, 07/28/22 
Updated Study Staff – added Anthony Bais
Version 2.6, 08/24/22
5.2.4. Oversampling 

Added mailed re-invitation to women to bolster our 30% oversampling aim 
5.4. Inclusion/Exclusion 
•
Clarification of exclusion criteria relating to weight loss programs, medications, surgeries
5.3.6.2. Format, Structure, and Content:

Removed reference to inclusion of VA resources for cooking classes and shopping.
5.5.7.3. Data Collection for Quantitative Evaluations of Implementation Process:

Fidelity section updated re: audits of intervention orientations and lifestyle coach 
communications
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Version 2.7, 12/5/22
Updated Study Staff-Gebremariam, Nathnael S.
5.2.5  Research invitation

Added option to remail/email to all nonresponders two weeks or more after initial 
mailing/emailing
5.2.6 Recruitment of Lifestyle Coaches for Interviews

Changed from interview to focus group for qualitative lifestyle coach assessments
5.5.6. Physiologic OSA Severity 

Added procedure should home sleep study tests reveal concerning results

Also added specifics re: 3% and 4% saturation values in reports

Added details re: $25 compensation for HSAT participation 
5.5.7.2. Data Collection for Qualitative Evaluation of Implementation Process 

Changed Lifestyle Coach qualitative evaluations from interview to focus group

Added details re: $25 compensation for interview participation
5.5.7.3. Data Collection for Quantitative Evaluations of Implementation Process

Edited costs and budget impact analysis section to more clearly and accurately explain 
our proposed analyses. 
Version 2.8 02/22/2023
Abstract

Updated ‘progress to date’ section to reflect that recruitment began 4/4/2022
5.1. Study Design

Updated figure 4 to align with study procedures. Specifically, we do not e-mail 
sleep providers prior to initial enrollment (See Section 5.3.2).
5.2.2
Recruitment

Revised language to reflect the fact that recruitment has already begun. 
5.2.3
Oversampling: 

Revised language to align with past as opposed to present tense.
5.3.2
Medical clearance:

Revised to state that we will also contact primary care providers to discuss safety of the 
one-night sleep study.
5.4 Inclusion Criteria:
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
Removed constraints around number of lifestyle coaches potentially involved in 
interviews. Instead, we will aim to interview all lifestyle coaches. 
5.5 Study Evaluations

Clarified timeline of compensation, in alignment with approved information 
statement. 
5.5.1 Primary Outcomes:

Clarified weight collection to align with outcomes currently registered with 
clinicaltrials.gov. The co-primary outcome of weight will include clinically 
measured weights identified from CDW. We originally planned to include self 
collected weights collected as a contingency. However, given the trajectory of the 
COVID-19 pandemic and clinic availability, we made the decision to only use 
clinical weights, and explore self-weights in in secondary analyses. Should clinical 
weight availability change as we enter primary outcome collection period, we may 
revisit this decision.

Also clarified that self-weights are not measured at baseline, but shortly following 
randomization when intervention scales are sent.

Updated Table 5 to align with changes above.
5.5.1
Secondary Outcomes:

Added descriptions of self-reported nightly sleep apnea treatment adherence and sleep 
duration at baseline, 3, 12, and 24 months. These are currently being collected in IRB 
approved forms.

Updated Table 5 to align. Also added reports of intervention participant self-monitoring 
and intervention adherence at 3 and 12 months which is documented in 5.3.6.4. 
5.5.4. Monitoring for eating disorders
 
 : 

Added additional question to 3-month surveys about the development of eating disorders. 
5.5.5 Physiologic OSA Severity:

Added details around pre-test screening and practices.

Clarified that we will conducting sleep studies among up to 200 participants per arm. 
5.5.6 Fidelity assessments

Peer audits of orientations will occur for up to 10 orientations per coach
5.6.1. Statistical Power for Primary Outcomes

Added power calculations around a potential 3.3kg difference between groups, which 
approximates a meaningful ~3% change in body weight. 
5.6.1. Data Analysis Plan

Clarified language in hypotheses to align with language submitted to DSMB
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
Added formal hypothesis (H2b) for comparing AHI between groups, as HSATs will only 
be collected at single point in time (12 months).

We will now plan on using the ANCOVA model: Y = b0 + b1Y0 + b2X + b3Q + e as our 
primary analytic model. 

Added secondary subgroup analyses. 
5.6.3. Missing and Misclassified Data

Explicitly stated that we will test our hypotheses using a complete case analysis. 
(Previously this statement was implied by our language that imputation would be used in 
secondary analyses).
5.7 Withdrawal of Subjects

Defined participants who are deemed to have been “lost to follow-up”.
6.3.1. Adverse event monitoring

Clarified ambiguous language around review of adverse events. Prior version could have 
been interpreted that PI and another clinician would both review each adverse event. The 
current version has been corrected to describe that PI or another clinician will review 
each adverse event.

In consultation with co-investigator psychologist, Dr. Katherine Hoerster, PhD we added 
eating disorders to list of expected adverse events given high prevalence within the 
Veteran population (Mitchell et. al. Psychol Assess, 2021, PMID: 34292003). 
7.0. Privacy and confidentiality

Clarified that we only need to identify a participants carrier if we are sending text 
messages via e-mail.
Version 2.9 03/17/2023
5.3.7. Participant compensation

We will offer additional compensation of $25 for completion of the 12-month 
survey outcome packet.
5.5.1 Baseline and follow-up effectiveness measures and data collection

Added language to this section as well regarding compensation of $25 for 
completion of the 12-month survey outcome packet.
5.5.2. Primary Outcomes: Contingency Weights

With the COVID emergency restrictions continuing to ease, we are decreasing 
patient burden by no longer requiring self-weights from all participants. Instead, 
we may ask for self-weights as needed in the case of missing data. 
7.0 Privacy and Confidentiality

Updated section on texting and Qualtrics to include sending batch texts through the 
Qualtrics platform
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Version 2.10 5/16/23
5.5.1 Primary Outcomes:

Added greater detail around the timeline for collecting clinical weight measures for the 24 
month time period (18-24 months).
5.5.5. Physiologic OSA Severity

Updated this section to include specifics re: contracted company, Sleep Care.

Reduced overall max number of sleep studies to 250 overall (125/arm) due to budget 
constraints
5.6.1. Data Analysis Plan

Revised primary and secondary analytic models to linear mixed effects model. This 
replaces our originally planned model of ANCOVA with complete case analysis. After 
discussion with our biostatistician, we decided to pursue a linear mixed effects model 
because it is valid under the missing at random assumption. (Note that no data has yet 
been analyzed, and we are just now collecting 12 month outcomes).

Added greater discussion around how we will impute missing covariate data.
8.0. Communication

Updated this section to include specifics re: contracted company, Sleep Care.
9.0. Information Security and Data Storage/Movement

Updated this section to include specifics re: contracted company, Sleep Care.
Version 2.11 6/14/23

Updated study staff list to add Ari Leonhard and remove Travis Hee Wei
5.0 Study Procedures:

Advanced the focus of long-term outcome by 3 months (24 months to 21 months post-
randomization). This change is made to allow uniform capture of longer-term outcomes in 
the funded timeframe of the study. For all outcomes (EHR & surveys), we will continue 
collection until participants are 24 months post randomization.
5.3.7. Participant compensation

Addition of using gift cards to compensate participants
Version 2.12 7/10/23

Updated study staff list to remove Nathnael Gebremariam
5.5 Study Evaluations:

To reduce primary care burden, we are changing our reminders for those with missing 
clinical measures. In lieu of walk-ins, we will ask all participants with missing weights at 
12 months to schedule visits for follow up weight measurements. We will not ask patients 
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to return for secondary outcomes including blood pressures or weights at the 21 month 
time period.
Version 2.13 8/14/23
5.3.7. Participant compensation

Revised window for survey outcome collection from 21-month to 24-month with payment 
following 21-months.
5.5.1 Baseline and follow-up effectiveness measures and data collection

Same as above, change from 24-month to 21-month for survey outcome collection and 
payment.
Version 2.14 11/22/23
5.5.5. Physiologic OSA Severity

If a participant requests the results of their home sleep apnea test, a member of the study 
team will call them and review the results.  We may also mail the report upon request
Version 2.15 01/11/2024
6.2. Data Safety and Monitoring Board

Removed reference to sending DSMB charter when available as one is available now
Version 2.16 01/25/2024
6.3.1. Adverse event monitoring

Updated adverse event chart review procedure for participants that do not complete a 
survey at 21-months post-randomization
Version 2.17 04/15/2024
6.3.1. Adverse event monitoring
• Updated adverse expected events to explicitly include death, in alignment with 
established Data Safety Monitoring Board analysis plan.
Version 2.18 07/02/2024
5.4. Inclusion/Exclusion Criteria & 5.5.2. Primary Outcomes:
• Added details around how weights pulled from the electronic health record are reviewed 
for suspect or erroneous values.
Version 2.19 03/04/2025
1.0 Study Personnel

Removal of Margaret Collins and Christian Helfrich from list of study personnel
6.3 Adverse event monitoring
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
Added a comparison of hospitalization rate between arms through 24 months using data 
compiled from the CDW.
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Abstract
1.
Objective(s) and Hypotheses:
Our primary aim is to test the effectiveness of a proactively delivered and pragmatic weight 
loss intervention to improve co-primary endpoints of sleep-related quality of life and weight 
among Veterans with obstructive sleep apnea (OSA) and obesity. Secondarily, we will 
compare additional outcomes between groups: cardiovascular risk scores, sleep symptoms, 
and AHI. Finally, we will also conduct an implementation process evaluation informed by the 
RE-AIM framework to identify predictors and determinants of population uptake of the 
intervention, alternative guideline-based treatments for OSA and obesity, and the 
achievement of patient-centered outcomes.
2.
Research Design:
We plan a hybrid type 1 pragmatic randomized controlled trial assessing effectiveness and 
an implementation process evaluation.  
3.
Methodology
We will proactively identify Veterans with OSA and obesity nationwide using data from the 
CDW (n=696), randomizing patients 1:1 to usual care plus the GLB weight loss intervention 
or usual care alone. We will collect primary outcomes at 12 months, but we will also collect 
outcomes at 3 and up to 24 months to assess trends over time. We will use quantitative and 
qualitative methods to assess determinants of implementation of our intervention and other 
guideline-based treatments for OSA and obesity, budget impact, and maintenance of patient-
centered outcomes. 
4.
Findings/Progress to Date:
Recruitment began on 4/4/2022, analysis has not begun. No interim analysis planned.
5.  Relevance to VA Mission
Our research tests a program of proactively providing Veterans with OSA the tools to 
manage weight loss in a way that is independent of local provider time and resources. Our 
research addresses a key gap in Veteran’s health in a way that aligns with important VA 
priorities including population health, virtual care, access, and health care value. We 
anticipate our intervention can efficiently achieve improvements in quality of life while 
reducing the burden and risk of serious comorbidities.
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List of Abbreviations

Adverse event (AE)

American Heart Association (AHA)

Body mass index (BMI)

Cardiovascular disease (CVD)

Centers for Disease Control and Prevention (CDC)

Centers for Medicare and Medicaid Services (CMS)

Chronic obstructive Pulmonary Disease (COPD)

Community based outpatient clinic (CBOC)

Compensation & Pension Record Interchange (CAPRI)

Computerized Patient Record System (CPRS)

Confidence interval (CI)

Continuous Positive Airway Pressure (CPAP)

Corporate Data Warehouse (CDW)

Data and Safety Monitoring Board (DSMB)

Department of Defense (DoD)

DVD Lifestyle Intervention (DELITE)

Diabetes Prevention Program (DPP)

Diabetes Prevention Support Center (DPSC)

Digital video disc (DVD)

Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care 
(E-LITE)

Health Economics Resource Center (HERC)

Health-related quality of life (HRQoL)

Health Services Research & Development (HSR&D)

Institute for Healthcare Improvement (IHI)

International Physical Activity Questionnaire (IPAQ)

Intra-class correlation (ICC)

Institutional Review Board (IRB)

Information Security Officer (ISO)

Intention to treat analysis (ITT)

Joint Legacy Viewer (JLV)

Group lifestyle Balance (GLB)

Managerial Cost Account (MCA)

Medical Outcomes 12-item short form (SF-12)

MOVE! Weight Management Program for Veterans (MOVE!)

MyFitnessPal (MFP)

National Archives and Records Administration (NARA)

National Center for Health Promotion and Disease Prevention (NCP)

National Institute of Health (NIH)

Office of Information & Technology (OI&T)

Obstructive Sleep Apnea (OSA)

Patient-Reported Outcomes Measurement Information System (PROMIS

Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach 
(POWER)

Pragmatic clinical trial (PCT)

Primary care provider (PCP)

Protected health information (PHI)
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
Principal Investigator (PI)

Randomized controlled trial (RCT)

Record control schedule (RCS)

Serious adverse event (SAE)

United States Preventive Services Task Force (USPSTF)

University of Pittsburgh (UP)

Usual care (UC)

VA Informatics and Computing Infrastructure (VINCI)

VA integrated service network (VISN)

VA Puget Sound Health Care System (VAPSHCS)

Veterans Affairs (VA)
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Contents
Summary of Edits:......................................................................................................................2
Abstract.....................................................................................................................................11
List of Abbreviations.................................................................................................................12
Contents....................................................................................................................................14
1.0
Study Personnel.............................................................................................................15
2.0
Introduction....................................................................................................................16
3.0
Objectives.......................................................................................................................23
4.0
Resources and Personnel..............................................................................................24
5.0
Study Procedures...........................................................................................................24
5.1 Study Design.....................................................................................................................24
5.2 Recruitment Methods.........................................................................................................25
5.3 Informed Consent and Randomization...............................................................................26
5.4 Inclusion/Exclusion Criteria................................................................................................29
5.5 Study Evaluations..............................................................................................................31
5.6 Data Analysis.....................................................................................................................36
5.7 Withdrawal of Subjects......................................................................................................39
6.0
Reporting........................................................................................................................39
6.1
Quality monitoring......................................................................................................39
6.2
Data Safety and Monitoring Board............................................................................39
7.0
Privacy and Confidentiality............................................................................................41
8.0      Communication..............................................................................................................42
9.0      Information Security and Data Storage/Movement......................................................42
10.0
References......................................................................................................................43
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1.0
Study Personnel
Name/
Contact
Role/
Affiliation
Access
PHI
Recruit-
ment
Surveys/
Interviews
Data
Analysis
Lucas M. Donovan, MD, MS
   Lucas.Donovan@va.gov
Principal Investigator (key)
VA Puget Sound
Y
Y
Y
Y
David H. Au, MD, MS
   david.au@va.gov
Co-Investigator (key)
VA Puget Sound 
Y
Y
Y
Y
Katherine Hoerster, PhD, MPH
   katherine.Hoerster@va.gov
Co-Investigator (key)
VA Puget Sound 
Y
N
N
Y
Steven Zeliadt, PhD
   steven.zeliadt@va.gov
Co-Investigator (key)
VA Puget Sound 
Y
N
N
Y
George Sayre, PsyD
   George.Sayre@va.gov
Co-Investigator (key)
VA Puget Sound 
Y
Y
Y
Y
Jennifer McDowell, MS 
   jennifer.mcdowell@va.gov
Project Manager
VA Puget Sound
Y
Y
Y
Y
Brianna Moss, BS 
   Brianna.moss@va.gov
Project Manager
VA Puget Sound
Y
Y
Y
Y
Robert Plumley 
   robert.plumley@va.gov
Programmer
SIBCR: VA IPA
Y
N
N
Y
Emily Gleason, BS
    Emily.gleason@va.gov
Coordinator
VA Puget Sound
Y
Y
Y
Y
Elizabeth Mattox, AARNP
   Elizabeth.Mattox@va.gov
Co-Investigator
VA Puget Sound
Y
N
N
N
Anthony Bais, BS 
Anthony.Bais@va.gov 
Coordinator 
VA Puget Sound
Y
Y
Y
Y
Aristotle Leonhard
   Aristotle.Leonhard@va.gov
Co-Investigator
VA Puget Sound
Y
N
N
Y
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2.0
Introduction
2.1. BACKGROUND: 
2.1.1. Obstructive sleep apnea (OSA) is a prevalent condition that poses a substantial 
burden to Veterans’ health. OSA results in impaired respiration during sleep, leading to 
frequent oxygen desaturations and poor sleep quality.1 OSA markedly reduces quality of life and 
is associated with serious comorbidities, including risk for cardiovascular disease that is up to 3 
times greater than the general population.1–4 Nearly 1.3 million Veterans are diagnosed with 
OSA, with prevalence rising two-fold in the last decade.5 Faced with OSA’s prevalence and 
associated morbidity, VA struggles to provide care that leads to meaningful improvements in 
health and wellbeing.6 
2.1.2. Obesity is the primary driver of OSA, but VA’s current approach to care exacerbates 
weight gain. Several population characteristics help explain Veterans’ high prevalence of OSA 
such as advancing age and male gender, but by far the greatest contributor is obesity.7 Excess 
weight explains a majority of OSA’s incidence and severity,7 and 75% of Veterans with OSA 
meet obesity criteria (~1 million Veterans). Despite the strong connection with obesity, VA’s 
primary approach to OSA does not involve weight loss. Instead, VA’s current strategy for OSA is 
to provide traditional first line disease management with positive airway pressure (PAP).1,6 While 
PAP reduces airway obstruction and improves symptoms of OSA, it does not reverse its 
underlying cause. In fact, PAP worsens obesity, causing 0.5-2 kg in weight gain through reduced 
metabolic demands.8,9 Furthermore, recent trials fail to demonstrate that PAP prevents 
cardiovascular events or improves metabolic disease (e.g. type 2 diabetes).10–12 Clearly, 
additional strategies are needed beyond PAP to reverse OSA and its associated comorbidities. 
2.1.3. Behavioral weight loss interventions show promise for OSA in carefully controlled 
efficacy trials, however important questions around real-world effectiveness remain. 
Lifestyle interventions targeting modest weight loss form the foundation of obesity 
management.13 Accordingly, a number of efficacy trials studied the impact of behavioral 
interventions targeting dietary changes and exercise in OSA.14 Participants randomized to weight 
loss in these trials achieved 5-7 kg in weight loss over 6-24 months and improvements in 
physiologic markers of OSA severity, with an average decline in apnea hypopnea index (AHI) of 
8.3 events/hour.14–16 Despite these promising results, recent clinical practice guidelines and state 
of the art reviews highlight a number of critical gaps in translating trial results into real-world 
impact.14,17 One major gap concerns meaningful outcomes. Existing trials focused primarily on 
the efficacy of behavioral weight loss interventions to improve AHI, a diagnostic marker with 
often limited correlation with meaningful patient-centered outcomes (e.g. sleep-related quality of 
life).18–22 While some secondary analyses suggest possible benefit, the evidence base is limited.14 
As a result, many question whether the benefits of modest weight loss in OSA are worth the 
expenditure of patient time, effort, and health system resources.14 Critical questions also remain 
around how to integrate weight loss into usual care for OSA.14 As we highlight below, such 
integration is lacking in VA.
2.1.4. Existing structures in clinical care for OSA do not support weight loss counseling. 
Similar to patients with other conditions managed in specialty care, the management of patients 
with OSA is siloed.23 Primary care providers are responsible for referring those with known or 
suspected of OSA, and sleep specialists provide diagnostic testing (e.g. polysomnography) and 
specialized disease management (e.g. PAP). In the current arrangement, there is no explicit 
understanding of who “owns” weight loss counseling. Furthermore, there is limited capacity in 
both groups for this task. VA has just ~300 sleep specialists nationwide to care for an OSA 
population of 1.3 million, limiting time for counseling and management of non-PAP care for 
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OSA.24–26 Primary care providers face similar time-pressures that prevent discussions of weight 
loss.27 As a result, fewer than 1/3 of Veterans with OSA discuss weight loss with providers, and 
Veterans rarely self-refer to VA’s weight loss services (Section 2.5.2-3). Rather than rely on 
providers whose time is already constrained, weight loss interventions among patients with OSA 
could benefit from a population health approach that is independent of specialist or primary care 
providers. Improving access to lifestyle interventions has the potential to expand treatment for 
OSA and obesity.
2.1.5. VA’s current weight loss offerings have poor accessibility, limiting overall 
effectiveness, particularly among patients with OSA. The behavioral weight loss 
interventions tested previously in OSA relied heavily on in-person sessions occurring at least 
once per week—intensity and structure replicated in VA’s MOVE! program. While the intensive 
in-person model may work in clinical trial populations of highly motivated subjects, this format 
limits reach and effectiveness in the real world. In-person visits are a barrier for the 50% of 
Veterans who live >30 miles from the nearest facility, and scheduled sessions often conflict with 
Veterans’ work and family obligations.28,29 While telehealth options for MOVE! are available, up to 
40% of enrolled Veterans do not regularly use the internet.30,31 These barriers limit access, and 
our preliminary data suggest only 12% of Veterans with OSA and obesity engage with any 
MOVE! services (Section 2.5.2). Poor access also prevents continued attendance. Two-thirds of 
Veterans attend just 1-3 MOVE! visits leading to limited overall effectiveness.31,32 For instance, 
Veterans with OSA in MOVE! lose just 1.2 kg at one year.33 Recognizing the limitations of VA’s 
offerings, the National Center for Health Promotion and Prevention (NCP) is interested in 
integrating new options to improve access, especially programs that are scalable, remote, and 
capable of reaching those with low tech literacy (See NCP Director Dr. Kim LOS). Disseminating 
accessible weight loss programs will be especially important in OSA. Patients with OSA often 
require greater engagement with behavioral weight loss programs in order to lose the same 
weight as peers without OSA,33–35 reflecting the need to overcome PAP-related weight gain and 
metabolic effects of sleep disruption.8,9
2.1.6. Summary of Background: Veterans with OSA comprise a large population where weight 
loss may offer substantial benefits to quality of life and reduce risks of morbid events. Despite 
promising results from efficacy trials of lifestyle-based weight loss programs, we have a limited 
understanding of weight loss’ impact on meaningful outcomes and integration of weight loss into 
usual care. Veterans with OSA rarely receive weight loss counseling, and existing weight loss 
offerings have poor accessibility. Our research informs efforts to overcome these gaps using a 
novel population health approach (Figure 1).
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2.1.7. Framework: We designed this pragmatic trial, POWER, with the Triple Aim as our primary 
framework.36 The Triple Aim provides a system-level model to optimize health system 
performance by simultaneously addressing three interdependent dimensions: patient experience 
of care, population health, and per capita health costs (Figure 2). Experience of Care: We 
propose a patient-centered approach to weight loss care among patients with OSA. Our remote 
intervention reduces geographic barriers and time required to travel and participate in 
appointments. The self-directed and remote nature of the intervention allows Veterans flexibility, 
enabling access for those with family and 
work obligations. Population health: Our 
intervention is independent of Veterans 
being seen in clinical care and uses 
administrative data to remotely identify and 
recruit patients, enabling centralized 
implementation. Unlike many other remote 
interventions, our intervention does not rely 
on Veterans having internet access or tech 
literacy, as course videos will be available 
by DVD and/or USB drive in addition to 
streaming. Per capita cost: The course 
videos for this intervention cost ~$16, and 
we will utilize a small number of staff to care 
for Veterans across multiple regions. We 
anticipate the intervention to be low-resource per capita. Finally, we acknowledge the Quadruple 
Aim and consideration of provider work-life.37 Our population health approach addresses weight 
loss without additional demands on existing providers..
2.2. SIGNIFICANCE: Nearly 1 million Veterans have OSA with comorbid obesity, representing a 
population with markedly reduced quality of life at high risk for morbid resource-intensive 
conditions.38,39 Although weight loss care has the potential to reverse OSA and other important 
comorbidities, such care is rarely offered, and when offered is frequently inaccessible. Providing 
scalable and accessible weight loss options is a high priority for NCP, and understanding how to 
integrate weight loss into usual care for patients with OSA is a key research priority for the field 
of sleep medicine (LOS from NCP and National Pulmonary, Critical Care, and Sleep Medicine, 
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NPCCSM, Program Director Dr. Yarbrough).14 Our trial would address existing knowledge gaps 
in a way that is responsive to VA priorities including population health, virtual care, access to 
care, and health care value. 1) Population Health and Whole Health: As outlined in the 
FY2018-24 strategic plan, a major priority of VA is to shift from a healthcare system focused on 
managing disease to one that supports Veterans in managing whole health and wellness.40 Our 
research uses this approach for OSA care, empowering Veterans with tools to adopt healthy 
living strategies to improve OSA. Our strategies for patient identification and intervention 
deployment also facilitate a population health approach that is independent of provider referral or 
local resources. 2) Virtual Care: Our lifestyle intervention, enables remote self-directed weight 
loss care using an evidence-based framework.41 This lifestyle intervention further extends the 
reach of virtual weight loss care to those with low technology access, a key goal of NCP. 
Furthermore, the remote nature of our intervention enables deployment irrespective of social 
distancing measures for COVID-19. 3) Access to Care: A chief goal of this research is to 
improve access to effective weight loss services, addressing gaps in VA’s current weight loss 
offerings caused by geographic inaccessibility, busy schedules, and technological barriers. 4) 
Health Care Value: By focusing on weight loss in OSA, our intervention efficiently targets quality 
of life in a way that may reduce risks for serious and resource intensive comorbidities (e.g., 
hypertension and cardiovascular disease). Our intervention aims to provide value to VA and 
Veterans by achieving meaningful improvements to population health at a small cost per-capita. 
We will rigorously assess the costs of the intervention and downstream utilization, and we will 
use these estimates to inform a budget impact analysis of widespread dissemination.
2.3. INNOVATION AND RESEARCH OVERLAP: Our study, POWER, is innovative in several 
ways. 
Care Delivery Redesign: We directly challenge traditional models of healthcare delivery. Typical 
care is fundamentally provider-driven, relying on providers to direct care and provide services 
aimed at managing a single disease. While the provider-driven model is well suited for many 
conditions, this model is often inadequate for the promotion of healthy behaviors. Due to 
competing demands for provider time and attention, counseling for healthy behaviors and 
lifestyle change is often neglected.24,27,42 POWER tests an alternative to this model by proactively 
offering and delivering weight loss services to a high-risk population.3,13,14 Remote and Self-
Directed Weight Loss: Obesity is a potent threat to both quality of life and health among 
patients with OSA, but weight loss services are often difficult to access.14 POWER will be the first 
trial of self-directed weight loss among patients with OSA, addressing critical questions around 
effectiveness in a population where higher levels of engagement are often needed to achieve 
weight loss.33–35 Meaningful Outcomes: Existing trials of lifestyle-based weight loss programs in 
OSA focused on their efficacy to improve AHI, an intermediate endpoint that often does not 
predict quality of life or other important patient-centered outcomes.18–22 To approach this gap, we 
focus on sleep-related quality of life as a co-primary outcome and will prioritize additional 
secondary outcomes important to patients and policymakers (e.g. sleep symptoms and 
cardiovascular risk).14 To further assess real-world effectiveness, we will use the RE-AIM 
framework to guide collection of implementation outcomes and estimates of public health 
impact.43Our group is in an ideal position to conduct this trial. We have experience in delivering 
the parent intervention, E-LITE, among patients with chronic obstructive pulmonary disease 
(NCT02634268). We also have an active trial deploying the current adaptation, D-ELITE, among 
Veterans in primary care (NCT03260140). These experiences provide us with expertise in 
delivering the intervention and collecting necessary outcomes (e.g., clinical, and self-collected 
weights). However, our ongoing trials do not inform critical knowledge gaps around a 
population health approach for high-risk patients or barriers and facilitators to widespread 
implementation. Furthermore, our existing trials do not inform meaningful outcomes among 
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patients with OSA, a large population for whom weight loss is difficult but may yield substantial 
benefits to health and wellbeing.
2.4. VETERAN ENGAGEMENT: To develop research that is consistent with Veterans’ values, 
Dr. Donovan presented this project to the Seattle-Denver Center of Innovation Veterans 
Engagement Board. This eight-member board is composed of a diverse group of patients 
including members with OSA who had prior experience with the MOVE! program. The input of 
the board was instrumental in shaping our research. Based on their personal experiences with 
OSA and weight loss, Veterans on the board questioned whether weight loss by itself was a 
meaningful endpoint. Consistent with a patient-centered approach and known knowledge 
gaps (Section 2.1),14 we are pursuing sleep-related quality of life as a primary endpoint, which 
the board felt to be more meaningful. Veterans also recommended additional considerations for 
improving access and broad-based engagement within the weight loss intervention. These 
include directing patients to existing resources to defray the costs of healthy eating and VA-
based training for healthy cooking. The board also recommended that we promote flexibility 
around the types of physical activity that Veterans pursue. We will continue to work with the 
board as we pursue this intervention, and we will engage with Veteran participants within our 
process evaluation.
2.5. RESEARCH DESIGN AND METHODS: 
2.5.1. Preliminary Studies: Our application draws on the strengths of our research team, 
fostering collaboration between VA and non-VA colleagues. Together, Drs. Donovan, Au, Ma, 
and Hoerster are recognized nationally as experts in sleep disorders, complex conditions, 
pragmatic trials, and weight loss interventions. We are ideally positioned to conduct this trial. 
Below, we describe the preliminary findings underlying this study’s rationale as well as our 
group’s experience in delivering the proposed intervention.
2.5.2. Veterans with OSA often do not discuss weight loss with providers and rarely 
engage with MOVE!: Supported by a VA Health Services Research and Development (HSR&D) 
Career Development Award and a multi-year grant from the Office of Veterans Access to Care, 
Dr. Donovan is conducting comprehensive evaluations of VA sleep care practices. In a 
representative cohort of 4,030 Veterans with obesity and OSA referred to sleep medicine from 
May 2018 to May 2019, only 12.2% had one or more MOVE! or nutrition visits in the year after 
referral. Highlighting geographic barriers, every 20 minutes of drive time were associated with 
0.85 odds (95% CI 0.74-0.96) of MOVE! utilization. Furthermore, weight loss in general was 
infrequently addressed. In surveys of randomly selected patients with OSA, only 32.7% of 
Veterans recall discussing weight loss with providers relative to 82.7% who recall in-depth 
counseling for PAP therapy. 
2.5.3. Among Veterans with OSA referred to MOVE!, weight loss is minimal: In collaboration 
with other VA researchers, Dr. Hoerster analyzed nationwide administrative data to assess 
weight loss among patients referred to MOVE!. Veterans with a diagnosis of OSA lost 1.1kg 
(95% CI 1.0-1.2) at 6 months and 1.2 kg (95% CI 1.1-1.3) at one year. Consistent with findings 
outside of VA, Veterans needed greater engagement with MOVE! in order to lose similar 
amounts of weight as peers without OSA.33–35
Together with information outlined in the background, and with concurrence of NCP, our findings 
reinforce the need for new weight loss options among patients with OSA that are accessible and 
effective. 
Table 1. Video session topics
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1. Getting Started Losing Weight
2. Be an Excess-Calorie Detective
3. Healthy Eating
4. Move Those Muscles
5. Tip the Calorie Balance
6. Take Charge 
7. Problem Solving
8. Four Keys to Healthy Eating Out
9. Slippery Slope of Lifestyle Change
10. Jump Start Your Activity Plan
11. Make Social Cues Work for You
12. Ways to Stay Motivated
2.5.4. Proven successful adaptation of the highly effective DPP weight loss intervention 
into a remote self-directed intervention:  The landmark DPP trial demonstrated that an 
intensive lifestyle intervention targeting modest weight loss and increased physical activity 
markedly lowered type 2 diabetes incidence in diverse populations, with effects persisting up to 
10 years.44 Despite the benefits of DPP on diabetes risk, the highly intensive intervention did not 
readily lend itself to implementation. DPP investigators adapted the resource intensive, primarily 
one-on-one lifestyle intervention to a group program with fewer sessions called Group Lifestyle 
Balance (GLB).45 The program is effective for weight and cardiometabolic risk reduction, 
implemented using existing staff (e.g. dietitians, lay health educators) in varied settings (e.g. 
primary care, medically under-served, rural).45,46   
Expanding on this work, Dr. Jun Ma adapted DPP and GLB to implement E-LITE (Table 1). The 
E-LITE self-directed intervention consisted of a single group orientation, after which patients 
received take-home DVDs (now available online and on USB drives) based on the GLB 
curriculum with twelve 25-minute weekly sessions and associated handouts (Table 1). Content 
focused on healthy diets, physical activity, and behavior change. These video sessions were 
supplemented by self-monitoring of weight and physical activity, and access to a trained lifestyle 
coach. Participants accessed a free and secure online portal for self-tracking (e.g., weight and 
activity), messaging between participant and coach, and automated reminders. In Dr. Ma’s 
randomized trial of 241 patients, both the self-directed E-LITE lifestyle intervention and an 
intensive coach-led group intervention produced comparable clinically significant weight loss 
over 2 years among adults at risk for diabetes (Figure 3). This finding is important as weight loss 
trends at 2 years are strong predictors of sustained weight loss.47,48
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Table 2.  Evolution of weight loss intervention programs and trials that resulted in the current trial
Study/Program
Brief Description
DPP Trial
Multicenter efficacy trial showing superiority of DPP lifestyle intervention to metformin and placebo. 
GLB Program
Direct adaptation of the DPP lifestyle intervention, recognized by the CDC National DPP initiative, 
disseminated through the University of Pittsburgh Diabetes Prevention Support Center (DPSC). 
E-LITE Study
Randomized trial in primary care integrating the GLB core curriculum with online monitoring. 
Compared delivery in-person or by take-home DVD to usual care. Results: The two GLB delivery 
modes showed comparable efficacy vs. usual care among privately insured patients. 
POWER Study
Pragmatic type I hybrid effectiveness-implementation trial of E-LITE with low-technology adaptations 
(D-ELITE) delivered proactively to Veterans with OSA and obesity. 
To improve the E-LITE self-directed intervention for ease of Veteran participation, D-ELITE 
replaces the single group-orientation visit with a one-time telephone-based orientation. This 
orientation includes an overview of diet and exercise strategies. D-ELITE offers Veterans options 
for how to engage with the intervention subsequently: DVD, USB, or online access to the same 
12-session videos, self-monitoring using paper booklets or a free web-based tracker 
(MyFitnessPal), and coach access by phone. Prior work indicates that the method of self-tracking 
is less important than the self-tracking behavior itself.49 Telephone based lifestyle coaching is 
recommended in the latest obesity treatment guideline.50 Together, these options improve 
flexibility of delivery and engagement for Veterans who do not use technology. Collectively, the 
D-ELITE intervention has been adapted from a highly efficacious, but limited reach intervention 
to one that is less burdensome to patients and VA (Tables 2,3).
2.5.5. Expertise in identifying 
and recruiting patients for 
pragmatic clinical trials: Drs. 
Donovan and Au have focused 
their research on improving 
delivery of care for patients 
with complex chronic 
conditions, including OSA. The 
success of this pragmatic trial 
relies on using existing 
resources and infrastructure to 
support clinical trial activities. 
Dr. Donovan has developed 
substantial experience in 
utilizing VA data structures to 
assess sleep related predictors 
and outcomes, including 
nationwide assessments of 
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Table 3. Original E-LITE self-directed and current 
intervention components summary
E-LITE Self-Directed
D-ELITE in the POWER study
One-time group-based in-
person orientation
One-time one-on-one telephone 
orientation.
Take-home DVDs with 
participant handouts for 12 
weekly sessions. (~25 min 
ea.)
Mailed USBs and/or DVDs with 
participant handouts for 12 weekly 
weight loss sessions. (~25 min ea.)
Recommended daily self-
monitoring of weight and 
physical activity online; 
patients entered weights and 
minutes of physical activity
Recommended daily self-
monitoring of weight, physical 
activity online OR via paper 
tracker; patients entered weights 
and minutes of physical activity
Access to a trained lifestyle 
coach for questions and 
counseling, at patient 
request, via online secure 
messaging
Access to a trained lifestyle coach 
for questions and counseling, at 
patient request, via secure 
messaging or telephone
Table 4. Weight Δ measured in clinic or by researchers
Trials
N
Clinic 
(slope)
Research 
(slope)
Slope difference 
(95% CI)
E-LITE
Self-directed
81
-0.05
-0.11
0.06 (-0.03, 0.15)
Coach-led
79
-0.11
-0.12
0.01 (-0.07, 0.08)
Control
81
 0.00
 0.01
-0.01 (-0.09,0.06)
BE WELL
 Coach-led
16
5
-0.02
-0.04
0.02 (-0.01, 0.06)
 Control
16
5
 0.00
-0.02
0.02 (-0.02, 0.06)
Table 4. Weight Δ measured in clinic or by researchers
Trials
N
Clinic 
(slope)
Research 
(slope)
Slope difference 
(95% CI)
E-LITE
Self-directed
81
-0.05
-0.11
0.06 (-0.03, 0.15)
Coach-led
79
-0.11
-0.12
0.01 (-0.07, 0.08)
Control
81
 0.00
 0.01
-0.01 (-0.09,0.06)
BE WELL
 Coach-led
16
5
-0.02
-0.04
0.02 (-0.01, 0.06)
 Control
16
5
 0.00
-0.02
0.02 (-0.02, 0.06)
 
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sleep study utilization.51 Dr. Au has a wealth of experience in using the Corporate Data 
Warehouse (CDW) to recruit for large clinical trials, including two adaptations of the E-LITE 
intervention (NCT02634268; NCT03260140).
2.5.6. Using clinical versus research weights.  Our approach in this trial will rely on clinically 
measured weights to assess one of our primary outcomes. To assess the validity of such an 
approach, we compared differences between research and clinically measured weights in two 
weight loss trials, E-LITE and BE WELL.52 In these trials, the slopes of weight change did not 
differ if clinic or researcher measured weights were used (Table 4). Furthermore, no difference in 
trial interpretation occurred when using clinic or research measured weights, supporting the use 
of clinical weights in pragmatic trials.52 
2.5.7. Availability of vital signs in CDW and feasibility of self-collected weights. Based on 
the validity of clinic relative to research weights, we pursued clinical weights as our primary 
outcome in a prior VA weight loss trial (NCT03260140). In this trial, 84% of participants had a 
repeat outpatient clinic-derived weight and blood pressure measurement within 3 months of a 12-
month follow-up. In a subset, we also asked participants to weigh themselves using study 
supplied scale in a manner approximating clinic weights (e.g., clothed with no shoes or jacket). 
These self-weights strongly correlate with clinic weights (r=0.94).  Our methods in capturing self-
reported weights achieved <5% missingness across our sample.
3.0
Objectives
In POWER, we propose a pragmatic hybrid type I randomized control trial of adding the lifestyle 
intervention to usual care for Veterans with OSA and obesity. We will take a population health 
approach by proactively offering weight loss and delivering the lifestyle intervention independent 
of provider referral or resources. Our primary focus is effectiveness for meaningful outcomes, 
and we will also assess determinants of widespread implementation of our intervention, 
alternative guideline-based treatments for OSA and obesity, and the achievement of patient-
centered outcomes.43
 
Primary Aim: Test the effectiveness of a proactively delivered and pragmatic weight loss 
intervention to improve sleep-related quality of life and weight among patients with OSA and 
obesity. 
Secondary Outcomes and Measures: 
1. Additional effectiveness outcomes including changes in sleep symptoms, cardiovascular risk 
scores, blood pressure, and physiologic OSA severity (AHI) 
2. Implementation outcomes informed by the RE-AIM framework including Reach, Adoption, 
Implementation (including costs/budget impact analysis), and Maintenance
Hypotheses:
H1 (Primary Hypothesis): Lifestyle intervention will lead to greater weight loss and 
improvement in sleep-related quality of life at 12 months relative to usual care.
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H2a (Secondary Hypothesis): Lifestyle intervention will lead to greater 
improvement in secondary outcomes relative to usual care.
H2b (Secondary Hypothesis): Self-directed lifestyle intervention will lead to lower 
12-month AHI relative to usual care.
4.0
Resources and Personnel
All study personnel are listed in Section 1.0, including their contact information. Also 
detailed in that section: affiliation, role in study, who will have access to protected health 
information, who will be recruiting, consenting, administering surveys and who will 
perform data analysis.
5.0
Study Procedures
5.1 Study Design
5.1.1. Proposed study design: POWER is a type 1 hybrid pragmatic RCT in which 696 
Veterans with OSA and obesity will be randomized to usual care or usual care enhanced with the 
D-ELITE self-directed lifestyle intervention for 12 months. Our primary outcomes are change in 
sleep-related quality of life and weight at 12 months (Figure 4). We will assess secondary 
outcomes at 3, 12 and 21 months.
Figure 4. 
We are also conducting an implementation process evaluation as described in 5.5.7.
5.2 Recruitment Methods
5.2.1
Enroll Veterans nationwide with OSA and obesity
5.2.2
Identify eligible participants through CDW: 
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We apply CDW algorithms to identify potentially eligible participants and verify eligibility 
via chart review using approved platforms including JLV/CAPRI (see Table 4, Section 
5.4). 
5.2.3
Screening for index weight/BMI: 
Using CDW, we will identify Veterans with prior sleep study (CPT 95800, 95801, 95806, 
95810, 95811), with associated diagnosis of OSA, an eligible BMI (index weight), a 
weight measurement indicating obesity (to minimize spurious inclusion), and who are 
likely free of exclusionary conditions searchable in CDW.  We will retain pertinent socio-
economic, demographic, and healthcare utilization data on all individuals identified to 
inform our organizational partners about the potential reach of the program.
5.2.4
Oversampling: 
We may oversample:
•
Women – our goal is to enroll approximately 30% of the cohort being female;
•
As we approached a third of our randomization goal, we observed that 
approximately 25% of enrollees were female. In order to increase our target 
oversampling, we may evaluate and re-mail an invitation to women. Our 
criteria include female non-responders who had an initial mailing at least 2 
weeks prior and have an end of window greater than 2 weeks away.
•
Minorities, if necessary, to have a balanced proportion of the cohort
5.2.5
Research invitation:  
Using patients identified through CDW, we will mail and/or email invitations to enough 
Veterans to enroll 696 subjects. The invitation will contain: 
•
Flyer;
•
Invitation Letter;
•
Information Sheet;
•
Opt in/out Post Card; 
•
Email decryption instructions;
We may pursue the option of posting the packet on the HSR&D public website for easy 
access in the future.
In order to meet our target recruitment timeline, we may re-mail and/or re-email to non-
responders if they have not replied two weeks or more after initial mailing/emailing.  
Once we meet our randomization goal, we will inform participants who have opted-in but 
are not yet randomized that enrollment is closed. 
5.2.6 Recruitment of Lifestyle Coaches for Interviews. Lifestyle coaches will be 
research study staff who will complete the Group Lifestyle Balance Training (described in 
5.3.5.3). To inform wider dissemination, we plan to assess staff experiences with the 
lifestyle coaching intervention. We will therefore perform qualitative focus group 
discussions among study staff members who are working in the lifestyle coaching role. 
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During this study, the qualitative Co-I on the team will contact each lifestyle coach by 
email to invite them to participate in a focus group discussion during year 2 of the project. 
The qualitative Co-I will not be the supervisor of any lifestyle coach that he or she invites.
The qualitative Co-I will schedule and perform the focus group discussion with verbal 
informed consent under a waiver of documentation of informed written consent. Note: 
The focus group discussion is not planned to occur until year 2 of the project. We may 
submit a modification with the email and edits to the interview guide.  
5.3 Informed Consent and Randomization
5.3.1
Telephone screen, consent, and baseline assessment: 
For those potential participants who do not return an opt-out postcard within 2 weeks (as 
well as those who return the opt/in card and those that opted in via Qualtrics), a research 
coordinator may telephone to:
•
Describe study and answer questions.
•
Assess eligibility, including potential exclusions for safety.   (Section 5.4)
•
Obtain consent under a waiver of documentation of written informed consent. 
•
Administer baseline surveys; or participant may complete online versions or paper 
copies and return via postage-paid mail.
5.3.2
Medical clearance:
For individuals who consent at the telephone screen and have fulfilled safety 
requirements, study staff will send a secure email to the patient’s primary care provider to 
inform them of their patient’s participation and to alert us if there is any reason that their 
patient should not participate. If the primary care provider does not respond after four 
days, we will send a second email. If no response to the second email, we will send a 
third email informing the PCP that we will enroll the individual in three business days 
unless they contact us otherwise. We will inform interested participants if their provider 
responded that this intervention is not appropriate.  
As outlined in section 5.5.6, a subset of POWER subjects will be selected to have a 
single-night diagnostic home sleep study at 1 year. Among those selected for this sleep 
study, study staff will send a secure email to the patient’s primary care provider and, if 
available, their sleep specialist. This email serves to inform their providers of their 
patient’s participation in a single-night sleep study, asks if they have any concerns about 
their patients’ participation in this diagnostic sleep study, and states that we will proceed 
with the sleep study unless the specialist contacts us within five business days. As 
diagnostic sleep studies, proposed in this trial, are often used as part of usual care to 
diagnose OSA and observe changes in patients’ OSA severity over time, we do not 
expect that many providers will object to participation. 
5.3.3
Randomization:  
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POWER staff will randomize each participant into the usual care or intervention group at 
a ratio of 1:1. Participants must have PCP clearance and completed baseline surveys 
before randomization can occur. Randomization should occur no more than sixteen 
weeks after the date of the index weight. After sixteen weeks we may ask the participant 
to return to the primary care clinic for a new index weight if still not randomized. We will 
notify participants of their randomization group via mail and/or email.  The mailing will 
include a weight scale for all participants and the additional materials (DVDs and/or USB 
drives, instructional handouts, GLB curriculum, Calorie King Fat & Carbohydrate Counter, 
and paper tracking booklets) for intervention participants.
5.3.4 Stratification: Given three stratifying variables of BMI category (strata: 30-34.9 vs. 35-44.9 
kg/m2), physiologic OSA severity (moderate to severe as defined by interpreting physician or 
apnea hypopnea index ≥15 events/hour vs. otherwise) and sleep related impairment (PROMIS 
Sleep Impairment T-score ≥ 60 vs. T-score <60) there will be 8 strata. Stratification may help 
prevent covariate imbalance between groups. 
5.3.5 Continuation of usual care: We will provide all control patients with the same weight 
scale as we provide to intervention patients. All participants will continue to receive standard care 
for OSA from their usual primary care and sleep providers. We chose usual care only for our 
control group because pragmatic RCTs are most useful in testing interventions in real-world 
settings and addressing the question “how does the intervention compare to what we are doing 
now?” We believe that including an alternate approach such as an attention control condition 
would undermine the purpose of this trial. Our study will not interfere with ongoing patient care, 
including referral to MOVE!, PAP prescriptions, or other sleep treatments. To protect external 
validity, no participant will be instructed not to seek weight loss or OSA treatment. We will include 
all participants in the intent to treat analysis. We will monitor electronic health record (EHR) data 
for participation in MOVE! and patient report for participation in non-VA weight loss programs. 
We will monitor PAP use through VA approved manufacturer-specific portals (Phillips Encore, 
ResMed AirView) as well as VA approved data management systems (e.g. Somnoware).53 
5.3.6. Intervention and its theoretical basis: Like its predecessors, POWER will use the GLB 
lifestyle intervention which is grounded in Social Cognitive Theory (SCT),54 and uses self-
regulation strategies (goal setting, self-monitoring, planning, and problem-solving) to achieve and 
maintain realistic intervention goals: losing 5-10% of baseline weight and participating in ≥ 150 
minutes/week of moderate-intensity physical activity. SCT emphasizes reinforcing relationships 
between the individual, environment, and behavior, recognizing that self-efficacy is enhanced 
through social support and gradual mastery of self-regulation. Further, SCT builds on an 
assumption that long-term changes in behavior are most likely to occur when the strategies used 
to motivate and support behavior change are flexible, sensitive to individual differences, and 
broadly acceptable to those in the target population. The GLB video program provides specific 
instruction in these goals for diet and weight loss (Section 2.5.3).
5.3.6.1 Evidence-based goals: Weight: The intervention is designed to achieve and maintain 
gradual weight loss of 5-10% of baseline body weight. This amount of weight loss is safe and 
feasible.41,44 To achieve and maintain weight loss, we will advise participants to reduce their 
calorie intake by 500-1000 kcal/day, as recommended in adult obesity guidelines, including OSA 
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specific guidelines and the VA DoD clinical practice guideline.13,14,50 Participants will gradually 
achieve calorie goals through portion control, low-energy, and nutrient-dense foods (e.g. fruit, 
vegetables, whole grains, non-sweetened dairy products), reduced consumption of refined 
carbohydrates/sugars, healthy food preparation techniques, and careful selection of restaurant 
items. Physical activity: The physical activity goal is to achieve and maintain a minimum of 150 
minutes per week of moderate-intensity physical activity (e.g., brisk walking). This goal is 
consistent with the Physical Activity Guidelines for Americans,55 and is safe and attainable for 
most adults including those with chronic health conditions. Participants will gradually and steadily 
increase daily walking with a goal of achieving 150 minutes of brisk walking per week by the end 
of the 12-week video program (Table 1). Participants may also choose to adopt regular activities 
of moderate intensity other than brisk walking,56 and we will encourage referrals to local 
rehabilitation services for individuals with addressable mobility limitations.
5.3.6.2. Format, Structure, and Content: There is a national call for providing multicomponent 
lifestyle interventions for obesity and integrating this care into OSA management.14,50,57 The 
challenge with such interventions is that they are difficult to deploy in the real world. The Center 
for Medicare and Medicaid Services reimbursement policy promotes brief (15 minute), lower 
intensity, face-to-face behavior counseling within a limited timeframe (6-12 months).14,50,57 Our 
intervention fits this general pragmatic framework within a self-directed approach using remote 
delivery and low staffing requirements. This study is intended to contribute to the evidence base 
needed to inform and further guide policy change, in the context of growing interest and evidence 
in effective and pragmatic interventions for OSA. 
Immediately after randomization, the study staff will mail a weight scale to all participants and the 
additional materials (DVDs and/or USB drives, instructional handouts, GLB curriculum, Calorie 
King Fat & Carbohydrate Counter, and paper tracking booklets) to intervention participants. 
Coaches will then call participants to confirm package receipt, review materials and instructions, 
confirm understanding, and address any questions.  Similar to the E-LITE self-directed 
intervention, we will deliver the intervention’s core curriculum in the first 3 months using the 12-
session GLB videos available via DVD, USB drive, or online streaming per Veteran preference. 
Veterans will also be able to choose to engage in self-monitoring of weight and activity using a 
web-based program (MyFitnessPal) or paper GLB booklets. A lifestyle coach will reach out every 
other week with messages through MyFitnessPal or text message reminding participants to 
watch the designated GLB video session and continue self-monitoring. We will instruct 
participants to contact the lifestyle coaches via MyFitnessPal messaging or phone if they have 
questions or would like behavioral counseling. Participants are asked to watch one ~25-minute 
video session a week. As recommended by guidelines, the main objective of the core curriculum 
(months 1-3) is to facilitate gradual weight loss through successive and progressive changes in 
diet and physical activity and behavioral skills training. Months 4-12 focus on continued self-
directed/monitored gradual weight loss and maintenance. Participants will have access to the 
lifestyle coach for all 12 months of the intervention.
Self-monitoring is key to successful behavioral weight-loss interventions.58 E-LITE results support 
a positive relationship between frequency of self-monitoring and weight loss.59 We will encourage 
participants to continue self-monitoring through MyFitnessPal or paper trackers beyond the 3-
month core intervention. The coaches will set up email reminders and text message alerts 
through MyFitnessPal or possibly ANNIE (does not require a smart phone). 
In prior deployments of E-LITE, patients required an initial 1-hour orientation, biweekly templated 
messages (2 minutes/message), and ad-hoc counseling sessions 2 times per month (7 
minutes/session). Based on these estimates, a 1-FTE coach could conservatively manage 450 
patients over the course of a year. This centralized, off-site staffing approach is not only 
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necessary for this protocol to be feasible (as opposed to identifying and training lifestyle coaches 
at the participants’ clinical centers) but also enhances practicality for regional implementation. 
The DPP training session, previously through the University of Pittsburgh, now conducted by 
SPARK Pro training, will train lifestyle coaches in diet and exercise counseling, with virtual 
options available given COVID-19 pandemic.
5.3.6.3. Lifestyle Coach selection and training: The lifestyle coaches will be study staff 
employed by VA Puget Sound as part of the research team. Each lifestyle coach will receive 
formal training from the University of Pittsburgh’s Group Lifestyle Balance Virtual Training 
Workshop now through SPARK Pro ( http://sparkprotraining.com/).
5.3.6.4. Adherence: As in E-LITE, POWER will not use special strategies to maintain or improve 
adherence to the intervention. Through MyFitnessPal messages or possibly ANNIE texting, 
participants will be periodically prompted to view the weekly session video and continue self-
monitoring. We will assess adherence in 3 ways. 1) Self-monitoring among Veterans using 
MyFitnessPal (83% of participants in prior trials of E-LITE) will be downloadable to the team. 
Remaining Veterans will use study-provided paper-based self-tracking booklets, which will be 
mailed back to study staff.  2) Number of sessions and handouts viewed will be tracked by 
engagement surveys sent at 3m and 12m post randomization. 3) We will record the number and 
indication for contact with lifestyle coaches. These assessments will allow us to explore 
relationships between adherence and outcomes in post-hoc analyses.
5.3.7. Participant compensation: Participants completing 12-month outcome surveys will 
receive $25. At the end of the 12-month period, participants that have completed the lifestyle 
intervention interview and/or the sleep study will be compensated for their participation with a 
$25 payment for either. At the end of the 21-month follow up outcomes data collection window, 
participants that completed any of the questionnaires will be compensated for their participation 
with a $25 payment. Participants will also be allowed to keep the body weight scale used during 
the study. Participant payments may be in the form of check, direct deposit or gift card.
5.4 Inclusion/Exclusion Criteria
Veteran Participant eligibility criteria: As we describe in more detail below, we will utilize the 
CDW to identify Veterans with recent sleep study and diagnosis of OSA with measured body 
mass index (BMI) between 30.0-44.9 kg/m2 recorded in the past three months. Including patients 
with recent sleep study will increase likelihood of accurately identifying participants with OSA,60 
and will allow recruitment after initial diagnosis or reassessment when patients may be more 
amenable to behavior change interventions.61 
To minimize spurious inclusion, we will ensure an additional BMI within the past 12 months of 
index weight that meets criteria set by a standard algorithm to remove implausible and erroneous 
BMI values.29,62,63  Specifically, we use the criteria used previously for the D-ELITE trial62,63 to 
exclude any index weight indicating excessive weight change prior to the index date: >40-pound 
change in any 30-day period in past year, or more than two pounds change per week over 
periods greater than 30 days. To exclude plausible but likely invalid index weights, we excluded 
weights if 1) the standard deviation of the difference between index and any past-year weight is 
greater than 5% of the average weight, 2) if the weight change is greater than ±100 pounds in a 
year, or 3)  if the BMI change is greater than ± 15 kg/m2. We also exclude weights greater than 
500 pounds or less than 90, height < 49 or > 84 in., and BMI greater than 65 or less than 15 
kg/m2 (calculated using the most recent height measurement between 49 and 84 in.). We apply 
the same algorithms for flagging potentially implausible and erroneous weights for outcome 
measurement (Section 5.5.2). 
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We will also confirm OSA by reviewing sleep studies, among those who have not opted out, prior 
to enrollment. We will calculate index and previous BMI using most recent height and weight. 
Exclusion criteria are chosen to ensure participant safety, while maximizing internal validity, and 
minimizing error caused by missing and misclassified data (Table 4).
Table 4: Inclusion and Exclusion Criteria
Inclusion

Diagnosis of OSA on sleep study (sleep provider confirmed)

Clinical BMI between ≥ 30, < 45 kg/m2, and at least one additional plausible BMI in last 12 
months

Access to television and DVD player, computer with USB drive, or internet

Able to participate fully in all study protocol/procedures including informed consent
Exclusion

Inability to speak, read, or understand English

Recent or active weight loss interventions including prescription weight-loss medications 
in last 90 days, participation in group or individual weight loss programs led by trained 
personnel in the past 90 days, and prior bariatric surgery or plans for bariatric surgery 
during the study period.

Expected weight loss because of alternate explanations such as from illness

High variability in weight due to fluctuations in volume status (e.g., ascites - liver disease, 
chronic heart failure) 

Safety and/or adherence concerns due to severe physical or mental health issues or life 
expectancy < 24 months. For example:  
o
1) Outpatient health encounter within the last year for malignancy, chronic 
respiratory failure, schizophrenia, psychosis, dementia, substance use 
disorders, anorexia, bulimia, binge eating disorder
o
2) Hospitalization in the last 6 months
o
3) Receiving hospice or palliative care.

Pregnant or planning to become pregnant during the study period

Participation in other intervention studies
Phone Screening prior to randomization: To further ensure identification of exclusions (Table 
4), study staff conduct a brief phone screening questionnaire during recruitment.  Included in this 
screening, as of February 2023, will be a series of questions aimed at identification of eating 
disorders.  Should a potential eating disorder be identified, the Veteran will not be enrolled in the 
study.
Non-Veteran Eligibility Criteria: As described in 5.2.6. We will approach all study staff 
employed as lifestyle coaches for qualitative interviews. 
5.5 Study Evaluations
5.5.1 Baseline and follow-up effectiveness measures and data collection: Table 5 shows 
the study measures and data collection schedule. We have extensive experience with the 
requirements for administering all the measures proposed. Research coordinators may 
administer baseline and 3, 12, and 21-month follow-up surveys via telephone, record responses 
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on paper, or Qualtrics, and enter values into study databases using double data entry and logic 
controls to minimize error. To emulate paper surveys and study staff calling after review, 
Qualtrics will prompt participants to respond to questions if they accidently left them blank. 
Furthermore, personalized survey completion messages will be incorporated into Qualtrics to 
direct participants to the next action. Other slight modifications (e.g., bolded fonts, transition 
pages, and sub-headers) of Qualtrics can be accounted by the formatting appeal of the online 
interface. We will assess information using a health inventory checklist including socio-
demographic characteristics, health behaviors, global impression of change, and non-VA weight 
loss programs. We will obtain additional information about comorbid conditions, medication use, 
healthcare utilization, and distance to clinics from the CDW. We will compensate participants $25 
if they complete the 12-month packet in the follow-up window and an additional $25 at the end of 
21-month follow-up period if they completed 3,12 (if not already compensated), or 21-month 
outcome surveys.
Table 5: Measures and timing of collection
Variable
Source
B
3m
12m
21-24m
Baseline variables and covariates
Height 
EMR
X
Clinical AHI
Chart review (JLV, CAPRI)
X
Demographics
Self-report 
X
Non-VA weight loss program
Self-report
X
X
X
X
Adherence to Intervention
Survey
X
X
Outcomes
Primary Effectiveness Outcomes
Sleep-related quality of life (FOSQ)
Surveys
X
X
Weight (clinical)
CDW 
X
X
Secondary Effectiveness Outcomes
Cardiovascular Risk Score
CDW
X
X
X
Weight (Clinical)
CDW
X
X
X
Weight (Self-report)*
Survey
X
X
X
FOSQ 
Survey
X
X
X
Blood Pressure
CDW
X
X
X
Global Impression of Change
Survey
X
X
X
Sleep Symptoms
Survey 
X
X
X
X
Well-Being
Survey
X
X
X
X
Objective PAP adherence
Remote Downloads 
X
X
X
X
Self-reported adherence to sleep 
apnea treatments
Survey
X
X
X
X
Sleep Duration
Survey
X
X
X
X
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Research AHI**
HSAT
X
*-Collected as needed as a contingency outcome if no clinical weights.  Also collected shortly after 
randomization following receipt of trial scale
**-Outcome only collected among a subset of up to 250 participants
5.5.2. Primary Outcomes: The co-primary endpoints for our pragmatic trial are changes in 
sleep-related quality of life and weight from baseline to 12 months. In secondary analyses, we 
will assess these outcomes at additional timepoints. Sleep-Related Quality of Life: The 
functional outcomes of sleep questionnaire (FOSQ) assesses multiple activities of daily living 
impacted by sleep disorders.64 FOSQ addresses domains that are important to patients: activity 
level, vigilance, intimacy/sexual relationships, productivity, and social outcome. FOSQ has a 
high degree of internal reliability, strong criterion, and construct validity when compared against 
generic quality of life measures (e.g. SF-36) and sleep symptom inventories.65 FOSQ is 
sensitive to changes in OSA treatment and is widely used in trials of OSA management. Weight 
Loss: Consistent with the pragmatic nature of this trial, we will prioritize clinically measured 
weights using methods shown to be feasible and valid when compared to research weights 
(Section 2.5.6). We will use participants’ qualifying outpatient clinical weight in the four months 
prior to randomization as their baseline measure. To assess change, we will select the 
outpatient clinical weight that is closest to the 12-month post-randomization date within a 9–15-
month post-randomization window, using a standard algorithm to remove implausible and 
erroneous values.29,62 Specifically, prior to unblinding, suspect weights will be flagged using 
criteria used in the D-ELITE trial.62,63 These criteria are the same as those used above for 
exclusion in the baseline period. Flagged weights will be reviewed in a blinded fashion by study 
staff for plausibility.  Weights determined to be implausible or likely erroneous will be excluded 
from analysis. As in D-ELITE, we will prioritize primary care clinic weights, however we will 
substitute another outpatient clinic weight from within our collection window if a primary care 
weight is missing. To reduce missingness, we will ask patients to schedule a visit with their 
primary care clinic for a weight if they do not have a clinical weight documented by 12-months. 
We have found that patients can have vital signs checked and entered into the EMR without an 
encounter or co-pay. We used these methods in a prior VA weight loss trial and obtained follow-
up clinic weights in 84% of participants (NCT 03260140). 
Contingency for weight:
We fully acknowledge that ongoing COVID-19 related changes in clinic utilization may alter the 
feasibility of the clinic-based approach. As a contingency, we may also request that participants 
weigh themselves with study-provided scales and report measured weights shortly after 
randomization as well as at 3, 12, and 21-month follow-up. If weights are reported via Qualtrics, 
we have incorporated a validation response to imitate paper survey values. Under a 
contingency approach that we will explore in secondary/sensitivity analyses, if a subject is 
missing a clinical weight, we may substitute the self-collected weights for baseline and/or follow-
up values in the analysis. We will provide written and verbal instructions to approximate clinic-
based weights (e.g., clothed, but no shoes or jackets). Should we experience widespread 
closures, limiting assessments of clinical weights, we may consider substituting clinical weights 
with self-weights in our primary analysis. We would make such a decision prior to analyzing 
primary outcomes.
5.5.3 Secondary Effectiveness Outcomes: We will assess additional secondary outcomes 
meant to gain a more complete understanding of the intervention’s impact. Consistent with the 
pragmatic nature of our trial, we prioritize outcomes that can be obtained from the electronic 
medical record, reducing participant burden.
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Secondary Effectiveness Outcomes Collected in General Clinical Care: Cardiovascular Risk 
Scores: We will use CDW data to calculate a cardiovascular risk score designed by the 
Framingham Heart Study,66,67 which incorporates age, BMI, systolic blood pressure, 
antihypertensive medication use, current smoking, and diagnosis of diabetes. The non-
laboratory risk score replaces lipid values with BMI and is comparable to the standard 
Framingham Risk score in predicting cardiovascular events.67 The non-laboratory Framingham 
score is particularly well-suited to pragmatic trials using data collected in usual care, and is 
responsive to weight loss interventions.68 Our group has extensive experience in obtaining each 
of the required data elements from CDW.51 We will also supplement collection of information 
about current antihypertensive use, smoking, and diabetes status with participant self-report on 
baseline and 3 , 12, and 21 month follow-up surveys. Blood pressure: We will obtain diastolic 
and systolic values from the CDW. Based on prior work in an ongoing trial, we anticipate >80% 
of subjects will have clinical follow-up measures (Section 2.5). PAP Adherence: We will explore 
the impact of weight loss on PAP usage and will assess PAP use as a mediator in secondary 
analyses of the intervention’s impact on primary and secondary outcomes.14 All PAP machines 
dispensed by VA transmit adherence, with results accessible in routine care through secure 
platforms.69,70 We will collect 90-day PAP adherence at 3, 12 and 21 months. We also collect 
self-reported adherence to PAP and other treatments at 3, 12, and 21 months.
Secondary Patient Reported Outcomes: Sleep Symptoms (Sleep-Related Disturbance and 
Impairment): We will assess sleep symptoms using the 8-item sleep disturbance and sleep-
related impairment scales from the NIH PROMIS set.71 Dr. Donovan validated these instruments 
to assess responsiveness to OSA treatment, and found greater responsiveness for PROMIS 
relative to the standard Epworth sleepiness scale.72 Together, these measures address the 
spectrum of sleep symptoms caused by OSA.73 Global impression of change: We will also have 
subjects rate their change in symptoms 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 their global change in symptoms on a 7 point scale from “1-Very Much Improved” to “7-Very 
Much Worse”.74 Well-being: We will use a 3-item survey designed to assess Veterans’ well-
being which assesses overall life satisfaction as well as their ability to be regularly involved and 
participating in activities that they find important.
5.5.4. Monitoring for eating disorders
 
 :   In addition to the outcomes outlined above, we will ask 
participants at 3-month surveys if they have developed symptoms consistent with eating 
disorders, using Veteran-centric language already in use by VA 
(https://www.womenshealth.va.gov/WOMENSHEALTH/topics/disordered-eating.asp). If 
participants indicate that they have developed new symptoms, we will contact them by 
telephone to confirm their selection. If confirmed, we will encourage them to discontinue any 
active lifestyle interventions focused on weight loss, and encourage them to discuss these 
symptoms with their primary care provider. If we are unable to reach participants indicating 
eating disorder concerns within 1 week, we will send them a letter summarizing the above 
information.
5.5.5. Physiologic OSA Severity: Including AHI as a secondary outcome measure in this 
pragmatic trial will be needed to contextualize our intervention’s impact for the sleep clinicians 
and policymakers who continue to rely on AHI as an “objective” marker. We will conduct sleep 
studies among a subset of participants to compare the impact of the intervention on AHI and 
estimate the proportion of patients with resolution of detectable OSA. Testing all 696 patients is 
not feasible in our budget. Therefore, we will select up to n=125 participants in each treatment 
arm to undergo home sleep apnea testing (HSAT) using level 3 home sleep apnea tests at the 
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12-month follow up. We will contract with a company, Sleep Care, Inc, to perform these home 
sleep apnea tests. 
We will quantify OSA severity with the apnea hypopnea index, with hypopneas defined using 
both the 4% and 3% desaturation rules, AHI4% and AHI3%. Of the two, we will prioritize the 
AHI4% as our measure of highest interest. Prior to distributing tests, we will conduct chart 
reviews to assess for safety issues that might make pausing treatment for one night unsafe 
(e.g., severe sleep-related hypoventilation). Following chart review, we will contact patients who 
expressed an interest at recruitment and are currently using reversible treatments (e.g., CPAP) 
and ask if they are still interested and able to pause treatment for one night. We will verify safety 
by asking about daytime sleepiness and any recent heart-related hospitalizations or issues.  222 
We will also contact patients’ providers to ensure that OSA treatment can be held for one night 
to assess untreated sleep. Following the call to the participant and contacting the provider, we 
will email or fax the patient’s contact information to Sleep Care, Inc to arrange delivery and 
instructions for the HSAT.
If results of the home sleep test reveal a previously unknown concerning result such as severe 
sleep related hypoxemia (low levels of oxygen), sustained bradycardia (low heart rate), 
sustained tachycardia (high heart rate), or serious arrythmia such as atrial fibrillation or 
ventricular tachycardia, study staff will contact the participant and discuss the findings.  Study 
staff will inform the participant that they will also contact the participant’s VA primary care 
provider and/or sleep specialist and make them aware of the finding.
If a participant contacts study staff asking for their HSAT results, a member of the study team 
will call the participant and review the results with them.  We may also mail them a copy of the 
sleep report if they request it.
We will also assess changes in other markers of respiration and oxygenation and the predictors 
of these changes.  Participants will be compensated $25 for participation in the home sleep test 
portion of the study.
5.5.6. Implementation Process Evaluation:  Consistent with a type I hybrid approach, we will 
use quantitative and qualitative methods to understand determinants of widespread 
implementation and other guideline-based treatments for OSA and obesity among Veterans with 
OSA. This secondary evaluation will be guided by the RE-AIM (Reach, Effectiveness, Adoption, 
Implementation, Maintenance) framework, which is a widely used implementation framework 
incorporating elements at both the individual and organizational level.75 
Table 6. Applying RE-AIM to POWER’s Implementation Process Evaluation
Element
Definition
Assessment
Reach
The absolute number, 
proportion, and 
representativeness of 
individuals participating in the 
intervention
- Descriptive statistics of patients nationwide who 
are eligible, invited, willing to participate, and 
retained in the intervention or receive other 
guideline-adherent interventions for OSA and 
obesity
- Among potentially eligible patients, analyze 
predictors of receiving the intervention and other 
existing treatments for OSA and obesity
- Compare characteristics of participants and non-
participants, and participants with intense and 
sustained participation
Effectiveness
Impact of intervention on 
outcomes
- Effectiveness outcomes as outlined above for 
trial population
- Use administrative data to assess patient-
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centered outcomes in the wider population of 
Veterans meeting one or more eligibility criteria 
who receive guideline-based treatments for OSA 
and/or obesity
Adoption
Settings and intervention 
agents who are willing to 
initiate the intervention
- Qualitative analyses among lifestyle coaches 
and patients to assess attitudes toward wider 
adoption of lifestyle interventions and perceived 
barriers
Implementation
Extent to which the intervention 
is delivered as intended 
(fidelity) along with the costs of 
the intervention
- Qualitative analyses among lifestyle coaches 
and patients assessing barriers and facilitators to 
the intervention
- Intervention costs and budget impact analysis
- Descriptive statistics of fidelity assessments
Maintenance
Long-term effects of the 
intervention on outcomes after 
intervention contact
- 21-month effectiveness outcomes for trial 
population
- Long-term patient-centered associated with 
guideline-based treatments for OSA and obesity
- Qualitative analyses among patients assessing 
barriers and facilitators to sustained lifestyle 
intervention engagement
5.5.6.2. Data Collection for Qualitative Evaluation of Implementation Process:  Eligibility 
and recruitment for qualitative interviews: Interview participants will include patient participants 
from the intervention arm and lifestyle coaches. Veteran Patients: Following the end of the 
intervention and primary outcome collection at 12 months, we will invite intervention participants 
for qualitative interviews. We will target our recruitment to include participants with a range of 
contact with the lifestyle coaches and diverse demographic and regional characteristics. We will 
interview until saturation is reached but anticipate recruiting at least 40 participants to achieve 
sufficient depth and breadth. Participants will be compensated $25 for participation in the 
interview.  Lifestyle coaches: We will invite all individuals performing lifestyle coaching for a 
focus-group discussion after intervention conclusion.  Qualitative data collection: We will audio 
record all interviews with a waiver of documentation of informed consent. We will use semi-
structured interview guides designed to address RE-AIM domains (Table 6). Guides will include 
open-ended questions to elicit perceived barriers and facilitators to proactive weight loss care 
with the lifestyle intervention. Research coordinators trained in qualitative interviews will conduct 
interviews with patients. Given the close working relationships between lifestyle coaches and 
research coordinators, qualitative co-investigator will conduct the focus group for lifestyle 
coaches himself. Recorded interviews will be transcribed.
5.5.6.3. Data Collection for Quantitative Evaluations of Implementation Process: 
Reach, Effectiveness, and Maintenance: We will collect data for effectiveness (3–12-month 
outcomes) and maintenance of effectiveness (21-month outcomes) as described above. We may 
also use VA administrative and PAP usage data from VA approved platforms (e.g., Somnoware) 
to assess effectiveness and maintenance measures among a nationwide population of Veterans 
who meet one or more inclusion criteria for the randomized trial.  We may also utilize data 
collected during patient screening and recruitment as well as intervention participation and 
adherence to inform predictors of reach as outlined in Table 6.  In order to compare the reach 
and effectiveness of our lifestyle intervention relative to existing strategies, we will identify 
Veterans meeting our criteria for OSA and obesity from FY18 through 23, and query CDW to 
assess their receipt of evidence-based services and patient centered outcomes in the five years 
prior and up to two years after OSA diagnosis.
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Costs and Budget Impact: Should the intervention be effective, we will conduct a budget 
impact analysis to establish a business case for future implementation efforts. Analysts 
will apply the above estimates of higher or lower cost differences between the study arms 
to project costs for implementing the self-directed lifestyle program nationwide among all 
VA patients with obesity and OSA. Analysts will estimate the number of VA patients at 
each site with OSA and obesity who are likely to use our intervention if it were to be rolled 
out more broadly based on the trial’s reach measures and facility-specific Veteran 
population projections  from the VA Enrollee Health Care Projection Model (EHCPM). 
Sensitivity analyses for subgroups or more targeted rollout strategies will potentially be 
developed based on discussion with VA operational partners. 
Quantifying Costs: Using validated frameworks, we will quantify VA-perspective costs 
based on A) within-trial costs for implementing the intervention (intervention group only) 
and B) downstream healthcare utilization (intervention and control).76,77 Similar to prior VA 
studies, study staff will  log all time spent monitoring adherence and on general 
intervention support including 1) lifestyle coach training, 2) individual lifestyle coaching 
activities (e.g. orientation, responding to ad hoc patient requests), and 3) planning.78 Staff 
time will be converted to costs based on salaries of the staff conducting the intervention 
using payroll information. Sensitivity analysis will explore alternative staffing models using 
estimates from US Bureau of Labor Statistics Occupational Outlook Handbook.   Time for 
research-specific activities including consenting and survey assessments will be 
excluded. All supply and other material costs will be extracted from intervention fidelity 
tracking data.  To assess potential increases or decreases in longitudinal healthcare 
utilization, we will compare differences in total utilization in the 24-month period following 
trial enrollment between the intervention and control groups. Healthcare utilization and 
total payer costs from will be extracted for all encounters using VA’s Managerial Cost 
Accounting data which is an activity-based allocation system based on payroll and all 
other care-related expenses (eg. supplies, utilities, service contracts) extracted from VA’s 
general ledger, and any claims patients incur for care delivered in the community that is 
reimbursed by VA. Confidence intervals for any observed differences in healthcare cost 
between the intervention and control groups will be estimated using bootstrapping, 
accounting for distributional assumptions for potentially skewed cost data. Costs will be 
reported in dollars at the time of reporting final results, with earlier years adjusted for 
inflation using the Consumer Price Index.  
Fidelity: After verbal participant consent, we will audit orientation sessions. We will select a 
random sample of up to 10 orientations for review per coach. These audits will be spread 
throughout the year long recruitment. The lifestyle coaches will follow a structured framework for 
composing messages, which we will sample (randomly select up to 10 messages per month) for 
periodic quality control review. The coaches will document the frequency, duration, and purpose 
of phone, MyFitnessPal, and email communications. These records will be subject to periodic 
reviews.
5.6 Data Analysis
5.6.1 Statistical Power for Primary Outcomes: We designed this pragmatic trial to achieve 
power of 0.9 for two primary outcomes at 12 months assuming 20% attrition. We target a two-
sided type I alpha of 0.025 for each outcome to account for a Bonferroni correction. FOSQ: We 
plan to detect a meaningful and important difference for FOSQ between groups, 0.75 points,65 
and assume the known standard deviation for change in FOSQ of 2.5 points.65,79–82 We will retain 
power of 0.8, even with up to 39% attrition (Table 7). Weight: Participants in D-ELITE’s self-
directed arm lost 4.5 kg.41 Assuming weight loss in our comparator group is similar to average 
Veterans with OSA seeking weight loss, 1.2 kg,33 we expect a 3.3 kg difference between groups. 
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This difference approximates a meaningful difference of 3% weight loss (Hoerster et al, JAMA, 
2022, PMID: 36511927). Given known standard deviation in clinical weight change among 
Veterans’ attempting weight loss of 6.9 kg/year,33 we will have 0.99 power to detect this 3.3 kg 
difference in weight change with 20% attrition (Table 7). We will detect a  2.1 kg difference with 
power of 0.90. Similar to FOSQ, we retain power even with substantial attrition (Table 7). 
Table 7. Power to detect differences in co-primary outcomes  
Change in Functional Outcomes of Sleep Questionnaire (FOSQ)
Power
Alpha
SD (score)
Difference (score)
N 
Attrition 
(%)
0.90
0.025
2.5
0.75
556
20
0.80
0.025
2.5
0.75
426
39
Change in Clinical Weight
Power
Alpha
SD (kg)
Difference (kg)
N 
Attrition 
(%)
0.99
0.025
6.9
3.3
556
20
0.90
0.025
6.9
3.3
220
68
0.80
0.025
6.9
3.3
170
76
0.90
0.025
6.9
2.1
556
20
5.6.2. Hypothesis Testing for Analyses of Trial Population: We will use intention to treat for 
analyses of primary and secondary outcomes of consented patients. 
H1 (Primary Hypothesis): Lifestyle intervention will lead to greater weight loss and 
improvement in sleep-related quality of life at 12 months relative to usual care.
H2a (Secondary Hypothesis): Lifestyle intervention will lead to greater improvement in 
secondary outcomes measured at baseline and follow-up relative to usual care.
H2b (Secondary Hypothesis): Self-directed lifestyle intervention will lead to more favorable values 
for outcomes only collected at follow up (e.g., AHI, global ratings of change).
Using intention to treat, we will test primary (H1) hypothesis separately for each outcome (weight 
and FOSQ) using linear mixed effects model
Y ij=β0+β1T j+β2 XiT j+β3Qi+ β4 Ai+ui+ϵ ij
which models for each patient i their measure for each outcome (FOSQ and weight separately), 
incorporating time of measurement T j (0 or 12 months), treatment by time interaction Xi T j, 
stratification variables Qi, and adjustment variables Ai including age, gender, race, Charlson 
comorbidity index, and rurality. The model will include a random normal intercept ui for each 
patient and a random normal error term ϵ ij, all assumed independent.  The variances of the ϵ ij 
will be assumed different at baseline and 12 months.  Here, β0 is the average baseline 
FOSQ/weight among the control and treatment groups combined (assumed equal due to 
randomization), β1 is the expected change in FOSQ/weight over time in the control group, and β2
, the quantity of interest in hypothesis H1, is the expected difference in the change in 
FOSQ/weight over time between the treatment and control groups, or equivalently the expected 
difference between groups at 12 months.  In secondary analyses, we will incorporate primary 
and secondary outcomes from each time point (baseline, 3, 12, and 21 months). We will use the 
same model to test secondary outcomes captured only at follow up, omitting baseline values.
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Additional Analytic Subgroups: 
1)
Subgroups defined by each of the pre-specified strata.
2) 
Subgroups defined by gender. 
3)
Patients who are prescribed continuous positive airway pressure and use <4 hours per 
night in the 90 days before the outcome period
4)
The subgroup of patients who are prescribed continuous positive airway pressure and 
use ≥4 hours per night in the 90 days before the outcome period.
5.6.3. Missing and Misclassified Data: Our pragmatic trial prioritizes outcome collection from 
EMR, including JLV and CAPRI, to reduce participant burden and enhance generalizability. 
While we attempt to minimize missingness and misclassification through efforts to optimize follow 
up survey completion and validated approaches to decrease measurement error,49,83  we 
anticipate missing data. We originally considered complete case analyses, but ultimately chose 
an approach based on linear mixed models and maximum likelihood that is valid under the 
missing at random assumption.84 Linear mixed models impute missing outcome data implicitly 
within a hierarchical model, using individuals’ baseline, adjustment, and stratification values. 
Missing values of covariates will be imputed using the chained equations approach (e.g. MICE),85 
using single imputation if missing rates are less than 5% and multiple imputation otherwise.  We 
will carry out the recommended sensitivity analyses to the MAR assumption using methods 
based on pattern mixture models and imputation, by assuming a range of perturbations of 
imputed outcome values and assessing differences in model conclusions.85,86 
5.6.4. Analysis for Qualitative and Quantitative Evaluations of Implementation Process: 
Reach, Effectiveness, and Maintenance:  We will compare those with OSA who are invited to the 
trial and enroll vs. those who do not. We will assess effectiveness and maintenance of 
effectiveness at 12 and 24 months in the trial population (Section 5.6.1-5.6.2). We may also use 
VA administrative and PAP usage data from VA approved platforms (e.g., Somnoware) to 
assess predictors and consequences of receiving our intervention or other guideline-based 
therapies for OSA and obesity among Veterans nationwide who meet one or more inclusion 
criteria for the randomized trial. 
Costs and Budget Impact Analysis: We will record intervention costs and conduct a budget 
impact analysis to establish a business case for future implementation, should the intervention 
be effective. We will compare mean cost differences between trial arms using linear models 
(Model 1) like our co-primary outcomes, ensuring model assumptions are met for cost data with 
appropriate transformations. Budget Impact Analysis: Should the intervention be effective, we will 
conduct a budget impact analysis to establish a business case for future implementation efforts. 
Analysts will apply the above estimates of higher or lower cost differences between the study 
arms to project costs for implementing the self-directed lifestyle program nationwide among all 
VA patients with obesity and OSA. Analysts will estimate the number of VA patients at each site 
with OSA and obesity who are likely to use our intervention if it were to be rolled out more 
broadly based on the trial’s reach measures and facility-specific Veteran population projections 
from the VA Enrollee Health Care Projection Model (EHCPM). Sensitivity analyses for subgroups 
or more targeted rollout strategies will potentially be developed based on discussion with VA 
operational partners.
Qualitative Data Analysis: We will analyze transcripts using simultaneous inductive and 
deductive content analysis.87 Inductive content analysis consists of open (unstructured) coding, 
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allowing for the emergence of previously unidentified themes. In contrast, deductive content 
analysis is structured and consists of identifying themes that fit within a priori categories. A priori 
categories will be based on RE-AIM domains, and we will use quotes that do not accurately fit 
within existing a priori codes to iteratively develop novel codes. We may use ATLAS.ti analysis 
software for recording and managing codes. The project team will review the results of the 
analytic process to assess completeness. 
5.7 Withdrawal of Subjects
We do not anticipate a need to withdraw a participant from the research entirely.  If a 
participant becomes pregnant, we become aware of a serious physical or mental health 
issue, or the participant’s primary care provider notifies us that the individual should not 
continue the intervention, the participant will cease participation in the intervention 
activities of the research; however we will continue to follow the individual through 
completion of the study via CDW and self-report.
If a participant chooses to withdraw him/herself from the research, we will confirm with 
the individual that we may continue to follow him/her in CDW.  If the individual declines, 
we will respect his/her choice and not collect additional data from CDW; however we will 
use any data collected up to the date of withdrawal.
For the purposes of follow-up, we will consider an individual “lost to follow up” if we are 
unable to collect either primary 12-month endpoint. 
6.0
Reporting
6.1
Quality monitoring  
The investigators will closely monitor and prepare annual summary reports on: 

Patient accrual and follow-up completion/retention in relation to goals and timeline.

Randomization process and group comparability on the balancing variables.

Key baseline characteristics of the sample, by blinded group, on the primary and secondary 
outcome variables.

Intervention adherence.

Protocol violations.  
6.2
Data Safety and Monitoring Board. 
This study will be reviewed regularly (at least annually) by a DSMB convened by the national 
director of VA HSR&D. This board will monitor the quality of data, progress of recruitment, as 
well as the incidence of adverse events between arms. 
6.3.1. Adverse event monitoring. 
To ensure unbiased determination across treatment arms, at 12- and 21-month follow-up contact 
we will ask participants to complete a survey about potential adverse events (AE), serious 
adverse events (SAE) and unanticipated problems (UP) employing a body system-based 
assessment. We define SAEs as those requiring hospitalization or death. 
Study staff will collect adverse events using participant self-reports collected at 12 and 21 
months. Study staff will also perform chart reviews looking for discharge summaries for the 12 
month time period. Study staff will later complete additional chart reviews looking for discharge 
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summaries for the 21 month time period among patients who do not complete 21 month surveys. 
Dr. Donovan or another clinician will assess each AE for duration (start and stop dates and 
times), expectedness in the study population, severity, outcome, treatment, and relation to study 
activity. 
To account for potential differential survey response rates by arm, we will also query the 
electronic medical record and compile hospital admissions from randomization through 24 
months post randomization.  We will report the number of hospitalizations by arm to in our final 
DSMB report.
The following are expected adverse events in the POWER population of participants who have 
obstructive sleep apnea, a high BMI, and adopt healthy eating and physical activity program:
•
Gastrointestinal symptoms related to change in diet.
•
Musculoskeletal symptoms or injury resulting from increased physical activity, 
including increasing symptoms such as chest discomfort, shortness of breath, and 
leg cramping. 
•
Development of weight and OSA associated medical disorders including diabetes, 
hypertension, liver disease, cardiovascular disease, cerebrovascular disease, 
arrythmias, asthma, COPD, clotting problems, and other lung related conditions; 
•
Development or exacerbation of mental health conditions, the worsening of which 
is known to be associated with poor sleep, including depression, anxiety, 
posttraumatic stress disorder, and bipolar disorder.
•
Development or exacerbation of eating disorders including binge eating disorder, 
anorexia nervosa, and bulimia nervosa.
•
Development of other conditions associated with unhealthy health behaviors, such 
as from tobacco and alcohol disorders (e.g., cancer).
•
Age related illnesses, such as pneumonia, urinary tract, and skin infections.
•
Motor vehicle collision or other accidents arising from excessive sleepiness.
•
Death
Upon discovering an unexpected and related SAE, study staff will provide the IRB and DSMB 
with a report describing the duration (start and stop dates and times), severity, outcome, 
treatment, and relation to study activity, according to the required timelines.  The DSMB may 
request additional information if it deems additional deliberation is warranted. 
For all other events, staff will summarize and report to the DSMB on an annual basis the 
numbers and types of all AEs by unidentified treatment arms. At their discretion, the DSMB may 
request unblinded results to determine the nature and extent of effect of the intervention.  Should 
the DSMB make this request, we will maintain blinding of the investigators and the staff involved 
in follow-up data collection and analysis.  If, at any time, the investigators believe they are seeing 
an unexpected increase in SAEs that is a cause of concern, they will bring this to the attention of 
the DSMB.
For annual reporting, staff also will provide the quality monitoring report to the DSMB. 
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At the annual meeting, the DSMB will review AE/SAEs and the quality of data, as well as review 
study progress and provide objective recommendations, as appropriate, with respect to:

Determination of any actions to be taken in response to SAEs.

Reports related to study operations and the quality of the data.

Consideration of early termination of the study because of treatment safety concerns or 
inadequate performance.

Modifications in the study protocol concerning recruitment, participant retention, data quality, 
outcome assessment, statistical analysis, or general trial operations.
7.0
Privacy and Confidentiality
This study will use PHI.  
To ensure the data are secure, the study team will code study data with a unique study code. We 
will maintain the master list separately from the study data.  The researchers will maintain data 
on the VA HSR&D network in password protected and permission specific directories and 
databases. Our network has multiple levels of protections and access is restricted to IRB-
approved staff. If a staff member leaves the study, we will remove his/her permissions to access 
the data. We will follow all VA HSR&D data security policies.
Paper copies will be stored in a secure office suite in locked files accessible by approved study 
staff only.  The ISO and Privacy Officer will be notified within one hour of the improper use or 
disclosure, as well as any other local policies.
All study information is accessible only by IRB approved study staff on a need-to-know basis.  
To report study results, we will use only aggregate data.
The study team considers all participant information confidential.  We will share information with 
participants’ physicians only as needed to protect participants’ safety.  We inform the participant 
of this practice as part of the informed consent process.  
We will offer participants the option of tracking their diet and exercise through MFP, which is a 
publicly available web-based platform. The loss of privacy with MFP is no greater than the risk of 
ordinary use of numerous similar publicly available online programs. As part of informed consent 
decision-making, we will describe this risk, as well as the potential benefits of participating in an 
intervention with demonstrated effectiveness and safety in other populations.  With that in mind, 
participants can choose if they wish to use MFP and/or a paper tracker. 
We also offer participants the option of responding to questionnaires via Qualtrics, a web-based 
survey platform licensed by VHA ORD. The loss of privacy with Qualtrics is no greater than the 
risk of responding to questionnaires on paper and by mail. As part of the informed consent 
decision-making process, we will describe the process of responding to online questionnaires. 
Participants will also have the option to utilize paper questionnaires instead. Survey links sent via 
unencrypted email or text message will not contain PHI. Emails or text messages containing 
mention of the POWER study will be encrypted (if emailed) and conform to VA data security 
policy. Incoming emails or text messages may either be bounced back to the sender as 
nondelivered, or an automatic response may contain an out-of-office and unmonitored message. 
Telephone number and supported carriers (i.e., T-Mobile, Verizon, AT&T, etc.) may be confirmed 
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prior to delivering text messages via e-mail. We may also send out “batch” texts via Qualtrics to 
participants with a phone number on file.  These batch texts will use the texting template and 
include an option to not receive links via text in the future.  Responses stored on Qualtrics 
servers will be associated with a unique study code, password protected, and encrypted. 
We will share contact information with a contracted company, Sleep Care, Inc, for a subset of 
participants to undergo at home sleep apnea testing. 
8.0      Communication
This is a single-site study. To ensure all elements of the study protocol are followed and 
that study goals are met, the project manager will conduct regular meetings with project 
staff to review study procedures and status, barriers encountered, and develop 
responses to any identified issues.
Study staff will send participant contact information to Sleep Care, Inc via either 
encrypted email or secure fax.  Sleep Care will contact participants using the contact 
information provided, first attempts will be by phone followed by HIPAA compliant email 
or text if the participant has provided cell phone or email contact.  Sleep Care will send 
the collected sleep data via reports either by secure email or fax.
9.0      Information Security and Data Storage/Movement
POWER staff will store paper-recorded data in secure, locked file cabinets within HSR&D secure 
office suite, and electronic data in password protected files on secure VA network servers or VA 
Office of Information and/or Technology (OI&T) managed archived back-up media. Online 
questionnaire responses collected through the Qualtrics platform are stored on password 
protected and encrypted servers. Qualtrics is FedRamp authorized, and all data will remain 
property of ORD. All electronic data will be stored according to VA data security policy.  Our 
network has multiple levels of protections and access is restricted to IRB-approved staff.  Limited 
analytic datasets are shared between authorized study personnel via secure transmission and/or 
via a secure virtual private network employing industry-standard password protection and data 
encryption. Study data is not disclosed to any third party except as required by law.  
A limited amount of contact information is provided to Qualtrics to allow the provider to distribute 
unique anonymized survey links. Information is transmitted to Qualtrics via secure, encrypted, 
web-based portal. 
We will also contract with a company, Sleep Care, Inc, to perform home sleep apnea testing 
among a subset of subjects in our trial. The company coordinate with the participant to mail 
home sleep apnea tests to these patients, collect the tests by mail, and will return data around 
their home sleep apnea testing results to the POWER team through secure means (e.g., secure 
fax, encrypted email). We will ensure that data transferred between the POWER team and the 
contracting company is accomplished through methods approved by privacy and ISSO as part of 
the contracting process. 
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Once the study is closed, we will retain these research data for the minimum period required for 
records retention in accordance with the National Archives and Records Administration (NARA) 
VHA Record Control Schedule (RCS). The VAPSHCS Research and Development Office will be 
responsible for overseeing the storage of the data during the RCS required records retention 
period and for the eventual destruction of the data as authorized by the RCS. When the minimum 
data retention period has ended, all research data records in the possession of VAPSHCS will be 
destroyed. At this same time, we will also work with VINCI staff to destroy these records from 
any VINCI server(s) and archived tape backups/media. For electronic data, the Office of 
Information and Technology (OI&T) is responsible for maintaining the security of the electronic 
records during the records retention period. The data will be destroyed by a method to be 
determined by the VAPSHCS Information Security Officer (ISO) in a manner that is compliant 
with VA Handbook 6500.1 and National Institute of Standards and Technology NIST SP 800-88. 
Study staff will enter all study data into SQL databases housed within HSR&D. Data collected via 
Qualtrics will be regularly downloaded and assimilated into SQL databases. All the data entry 
systems will employ automatic, real-time range, logic, and missing value checks.   We will 
employ double data entry and logic controls to minimize data entry error.  We will maintain one 
official copy of all the study data and a master data dictionary. 
10.0 References
Bibliography of cited literature
1.
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The Management of Chronic Insomnia Disorder and Obstructive Sleep Apnea. 2019. 
2.
Kapur VK, Auckley DH, Chowdhuri S, et al. Clinical Practice Guideline for Diagnostic Testing 
for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical 
Practice Guideline. Journal of clinical sleep medicine : JCSM : official publication of the 
American Academy of Sleep Medicine. 2017;13(3):479–504. 
3.
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obstructive pulmonary disease and obstructive sleep apnea: the overlap syndrome. 
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Patil SP, Ayappa IA, Caples SM, et al. Treatment of Adult Obstructive Sleep Apnea With 
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Outcomes. 2020. 
7.
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10. Shaw JE, Punjabi NM, Naughton MT, et al. The Effect of Treatment of Obstructive Sleep 
Apnea on Glycemic Control in Type 2 Diabetes. American journal of respiratory and critical 
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Obstructive Sleep Apnea. The New England journal of medicine. 2016;375(10):919–31. 
12. Peker Y, Glantz H, Eulenburg C, et al. Effect of Positive Airway Pressure on Cardiovascular 
Outcomes in Coronary Artery Disease Patients with Nonsleepy Obstructive Sleep Apnea. 
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13. Department of Veterans Affairs and Department of Defense. Clinical Practice Guideline for 
Screening and Management of Overweight and Obesity. 2014. 
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of Adult Obstructive Sleep Apnea. An Official American Thoracic Society Clinical Practice 
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16. Kuna ST, Reboussin DM, Borradaile KE, et al. Long-term effect of weight loss on obstructive 
sleep apnea severity in obese patients with type 2 diabetes. Sleep. 2013;36(5):641-649A. 
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College of Endocrinology and the American Association of Clinical Endocrinologists. 2016;22 
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18. Vinnikov D, Blanc PD, Alilin A, Zutler M, Holty JC. Fatigue and sleepiness determine 
respiratory quality of life among veterans evaluated for sleep apnea. Health and quality of life 
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19. Punjabi NM, Newman AB, Young TB, Resnick HE, Sanders MH. Sleep-disordered breathing 
and cardiovascular disease: an outcome-based definition of hypopneas. American journal of 
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23. Zuchowski JL, Rose DE, Hamilton AB, et al. Challenges in referral communication between 
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27. Gutierrez JC, Terwiesch C, Pelak M, Pettit AR, Marcus SC. Characterizing Primary Care 
Visit Activities at Veterans Health Administration Clinics. Journal of healthcare management / 
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from a national primary care weight management program. Primary health care research & 
development. 2015;16(2):147–56. 
29. Littman AJ, Boyko EJ, McDonell MB, Fihn SD. Evaluation of a weight management program 
for veterans. Preventing chronic disease. 2012;9:E99. 
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information online. Military medicine. 2013;178(4):394–400. 
31. Maciejewski ML, Shepherd-Banigan M, Raffa SD, Weidenbacher HJ. Systematic Review of 
Behavioral Weight Management Program MOVE! for Veterans. American journal of 
preventive medicine. 2018;54(5):704–714. 
32. Jackson SL, Long Q, Rhee MK, et al. Weight loss and incidence of diabetes with the 
Veterans Health Administration MOVE! lifestyle change programme: an observational study. 
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33. Janney CA, Kilbourne AM, Germain A, et al. The Influence of Sleep Disordered Breathing on 
Weight Loss in a National Weight Management Program. Sleep. 2016;39(1):59–65. 
34. Kline CE, Burke LE, Sereika SM, et al. Bidirectional Relationships Between Weight Change 
and Sleep Apnea in a Behavioral Weight Loss Intervention. Mayo Clinic proceedings. 
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35. Borel AL, Leblanc X, Almeras N, et al. Sleep apnoea attenuates the effects of a lifestyle 
intervention programme in men with visceral obesity. Thorax. 2012;67(8):735–41. 
36. Berwick DM, Nolan TW, Whittington J. The triple aim: care, health, and cost. Health affairs. 
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38. Giles TL, Lasserson TJ, Smith BJ, et al. Continuous positive airways pressure for obstructive 
sleep apnoea in adults. The Cochrane database of systematic reviews. 2006;(1):CD001106. 
39. Haentjens P, Van Meerhaeghe A, Moscariello A, et al. The impact of continuous positive 
airway pressure on blood pressure in patients with obstructive sleep apnea syndrome: 
evidence from a meta-analysis of placebo-controlled randomized trials. Archives of internal 
medicine. 2007;167(8):757–64. 
40. Department of Veterans Affairs. FY 2018-2024 Strategic Plan. 
41. Ma J, Yank V, Xiao L, et al. Translating the Diabetes Prevention Program lifestyle 
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