DVD Lifestyle Intervention (D-ELITE)
Phase: NA
Conditions: Obesity
Sponsor: VA Office of Research and Development

 
 
DVD Lifestyle Intervention (DELITE)       
 
MIRB: 00993 
 
RDIS: 0025 
 
Funding Agency: HSR&D (1 I01 HX002113-01A2) 
 
Grant Number: IIR 15-364 
 
Principal Investigator: Katherine Hoerster, PhD., MPH 
 
Version 2.1, March 17, 2021 
 
 
Human Subjects Protocol 
VA Puget Sound IRB 
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Summary of Edits: 
 
Version 1.1, September 27, 2017: 
 
Minor typographical corrections and rewording for clarity throughout 
 
List of Abbreviations: Updated 
 
D-ELITE change to DELITE throughout 
 
Section 5.2.5: Research Invitation: 
• Clarification about posting blank participant packets on the HSR&D public website. 
 
Section 5.3.1: Telephone screen, consent, and baseline assessment: 
• Clarified who the research team will contact for enrollment. 
• Updated time by which baseline assessments must be received after index weight. 
 
Section 5.3.3: Randomization: 
• Added time by which randomization must occur after index weight. 
• Updated materials provided to participants. 
 
Section 5.3.5.2: Intervention format, structure, and content: 
• Clarified contents of GLB curriculum. 
 
Section 5.5.3: Secondary outcomes: 
• Updated secondary outcomes.  
 
Section 5.5: 
• Updated Table 5 per changes in secondary outcomes. 
 
 
Version 1.2, January 8, 2018: 
Cover Page: 
• Added RIDS and Grant Number 
 
Section 5.5: 
• Updated methods of contact for delinquent surveys 
 
Version 1.3, July 27, 2018 
Section 5.2.5 
• Added informing participants who have opted-in but are not yet randomized that enrollment is closed, 
once randomization target met.  
 
Section 5.5 
• Added mailing retention letter around 4, 8, 16, and 20 months 
 
Section 6.3 
• Replaced Dr. Alexis Beatty with Dr. Ashok Reddy on the Data Monitoring Committee  
 
Version 1.4, January 10, 2019 
Section 1.0 
• Updated study staff 
 
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Section 5.5 
• Added mailing retention letter around 4, 8, 16, and 20 months 
 
Section 6.3 
• Replaced Dr. Alexis Beatty with Dr. Ashok Reddy on the Data Monitoring Committee  
 
Version 1.5, February 25, 2019 
Section 5.5.2 
• Clarified when Drs. Au or Hoerster may enter weights into CPRS. 
 
Version 1.6, June 6, 2019 
Section 1.0 
• Updated study staff 
 
Version 1.7, August 12, 2019 
Section 1.0 
• Updated study staff 
 
Version 1.8, December 9, 2019 
• Title Page Updated PI 
Section 1.0 Study Personnel 
• 
Change Hoerster to PI and Au to Co-PI 
• 
Addition of Lucas Donovan as co-investigator 
• 
Edit list of names to follow same format First Name Last Name, degree 
Section 5.5.2.1 Weight 
• 
Added clarification “starting with 12 months prior to index weight” for time line of CDW pulls for primary 
care weight 
Section 5.5.3 Secondary outcomes 
• 
Added clarification “starting with 12 months prior to index weight through 27 months” for time line of blood 
pressure data pulls 
• 
Added blood sugar levels to secondary outcomes 
• 
Clarified Table 5 to include data pulls 12 months prior to index weight 
Section 5.5.4 Participant Payment 
• 
Clarified payment timeline 
• 
Added new procedure of potentially sending a “close out” letter after completion of 24m survey and 
payment sent or 90 days after reminder mailing for non-responders. 
Section 5.6.3 Hypothesis testing and statistical analysis 
• 
Added HbA1c levels to secondary outcomes analysis 
 
Version 1.9, March 23, 2020 
Section 1.0 Study Personnel 
• 
Updated staff list to reflect changes in staffing as found on current Study Staff page  
Section 5.5.2.1 Weight 
• 
Added alternate procedure for clinic weight at 24months during times when going into the clinic for a 
weight is not feasible 
 
Version 2.0, January 20, 2021 
Throughout: 
• 
Revised incorrect use of “obese” as an adjective 
Abstract 
• 
Updated to reflect revisions implemented in ClinicalTriasl.gov June 2020 
Section 1.0 Study Personnel 
• 
Updated staff  
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Section 5.1 Study design 
• 
Corrected timepoint for primary outcome from 24 months to 12 months 
 
Section 5.5.3 
• 
Clarified the dietary quality/self-efficacy scale 
Section 5.6 Analysis 
• 
Updated analysis section to reflect decision made in preparation for submitting the Protocol manuscript 
to Contemporary Clinical Trials (available online May 28, 2020: 
https://doi.org/10.1016/j.cct.2020.106045) 
Section 6.1 
• 
Modified description of staff who will review adverse events to remove specific names 
 
Version 2.1, March 17, 2021 
Section 5.3.3 Randomization, 5.4 Inclusion/Exclusion Criteria, and 5.6.3 Hypothesis Testing and Statistical 
Analyses 
• 
Added specificity to BMI randomization strata 
Section 5.4 Inclusion/Exclusion Criteria 
• 
Corrected timeframe for inclusionary weights  
Section 5.5.2 Outcomes 
• 
Clarified outcome descriptions 
• 
Specified how we will measure “Reach” 
• 
Updated Table 5 according to the above 
Section 5.6.3 Hypothesis Testing and Statistical Analyses 
• 
Added analysis details 
Section 5.6.5 Misclassification and Missing Data 
• 
Moved information about missing data from section 5.6.3 to this section 
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Table of Contents 
Summary of Edits: ........................................................................................................................................... 2 
Abstract ............................................................................................................................................................ 6 
List of Abbreviations .......................................................................................................................................... 7 
1.0 
Study Personnel .................................................................................................................................... 9 
2.0 
Introduction ........................................................................................................................................... 9 
2.1 
Background ................................................................................................................................... 9 
2.2 
Significance ................................................................................................................................ 11 
2.3 
Preliminary Studies/Gaps in Knowledge ................................................................................... 12 
2.3.1 
Predecessor to DELITE: .................................................................................................. 12 
2.3.2 
Experience with using Clinical vs Research Measured Weights: ...................................... 14 
3.0 
Objectives ............................................................................................................................................ 15 
3.1 
Scope of Problem to be Addressed ........................................................................................... 15 
3.2 
Challenge .................................................................................................................................... 15 
3.3 
Opportunity ................................................................................................................................. 16 
3.4 
Impact .......................................................................................................................................... 16 
4.0 
Resources and Personnel ................................................................................................................... 16 
5.0 
Study Procedures ................................................................................................................................ 16 
5.1 
Study Design ............................................................................................................................... 16 
5.2 
Recruitment Methods ................................................................................................................. 17 
5.2.1 
Enroll Veterans within the Pacific and Mountain Time zones: .......................................... 17 
5.2.2 
Identify Eligible Participants through CDW: ...................................................................... 17 
5.2.3 
Screening for Index Weight/BMI:...................................................................................... 17 
5.2.4 
Oversampling:.................................................................................................................. 17 
5.2.5 
Research Invitation: ......................................................................................................... 17 
5.3 
Informed Consent and Randomization ...................................................................................... 17 
5.3.1 
Telephone Screen, Consent, and Baseline Assessment: ................................................. 17 
5.3.2 
Medical Clearance: .......................................................................................................... 18 
5.3.3 
Randomization: ................................................................................................................ 18 
5.3.4 
Continuation of Usual Care: ............................................................................................. 18 
5.3.5 
Intervention: ..................................................................................................................... 18 
5.4 
Inclusion/Exclusion Criteria ....................................................................................................... 19 
5.5 
Study Evaluations ....................................................................................................................... 20 
5.5.1 
Baseline Variables and Co-variates: ................................................................................ 20 
5.5.2 
Outcomes: ....................................................................................................................... 20 
Table 5. Measures and timing of data collection. ..................................................................... 22 
5.5.3 
Participant Payment: ........................................................................................................ 22 
5.6 
Data Analysis .............................................................................................................................. 23 
5.6.1 
Power/Sample Size:......................................................................................................... 23 
5.6.2 
Retention: ........................................................................................................................ 23 
5.6.3 
Hypothesis Testing and Statistical Analyses: ................................................................... 24 
5.6.4 
Budget Impact Analysis: .................................................................................................. 24 
5.6.5 
Misclassification and Missing Data: .................................................................................. 25 
5.6.6 
Interim Analyses: ............................................................................................................. 25 
5.7 
Withdrawal of Subjects .............................................................................................................. 25 
6.0 
Reporting ............................................................................................................................................. 25 
6.1 
Safety Assessment ..................................................................................................................... 25 
6.2 
Quality Monitoring ...................................................................................................................... 26 
6.3 
Data Monitoring Committee (DMC) ............................................................................................ 26 
7.0 
Privacy and Confidentiality ................................................................................................................. 26 
8.0 
Communication Plan ........................................................................................................................... 27 
9.0 
Information Security and Data Storage/Movement ........................................................................... 27 
10.0 References ........................................................................................................................................... 28 
 
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Abstract 
Most Veterans who receive VA healthcare have obesity (41%) or are classified as overweight (37%), putting 
them at higher risk for multiple serious chronic health conditions. Providing evidence-based behavioral weight 
management programs to Veterans with obesity is a priority for the VA National Center for Health Promotion and 
Disease Prevention (NCP). While the VA NCP's MOVE! program - primarily delivered with in-person group visits 
- helps Veterans with obesity lose weight, its reach has been limited because of various barriers to care. Some 
Veterans may do better with a program they can complete from home at their own pace. In this trial, study 
investigators are examining the effectiveness among Veterans of a previously proven self-directed lifestyle 
intervention (called DVD Lifestyle Intervention (D-ELITE)) that targets modest, clinically meaningful weight loss 
over the course of a year using recorded video lessons (DVD or online streaming), written self-study aids, and 
optional lifestyle coaching. The study will compare participants randomly assigned to receive D-ELITE to those 
continuing in usual care on weight and self-reported general physical health status, one year after enrollment. 
Secondary outcomes include weight and general physical health status two years after enrollment; and obesity-
related biometric measures (blood pressure and HbA1c) and self-report psychological and behavioral factors 
such as physical activity and sleep quality, at one- and two-years following enrollment. 
 
Veterans with obesity living in the western US were identified using the VA Corporate Data Warehouse (CDW), 
recruited to participate via mail and telephone, and randomly assigned to receive the study intervention or usual 
care alone. The study uses CDW to assess weight change and biometric outcomes. To assess self-report 
outcomes, participants completed questionnaires, by mail or telephone, at baseline and 12 months after 
randomization, and are currently completing 24-month follow-up questionnaires. The D-ELITE intervention 
focuses on gradual lifestyle behavior change aimed at improving eating habits and increasing physical activity. 
It encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 
150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The D-ELITE intervention 
program consists of watching one video, completing corresponding written self-guided learning materials, and 
tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional 
written handouts and continued food and activity tracking for the next nine months. Intervention participants have 
access to a lifestyle coach, as desired, for the full 12-month intervention period. In addition to patient outcomes, 
this study will examine the cost of delivering the intervention, information relevant to decision-makers and 
potential future dissemination. Evidence-based programs like this, which can be delivered remotely and with 
likely minimal resources required from the VA healthcare system, are greatly needed, especially now as the 
SARS-CoV-2 pandemic has required VA to rapidly transition to providing more remotely-delivered care. 
 
Impact: The DELITE trial has potential to provide the evidence needed for deciding whether a low-cost, low-
technology, self-directed program can be used to expand the treatment of obesity to a population-based level 
by improving access to obesity treatment regardless of Veteran place of residence. 
 
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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) 
• 
Corporate Data Warehouse (CDW) 
• 
Data Monitoring Committee (DMC) 
• 
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) 
• 
Group lifestyle Balance (GLB) 
• 
Health Economic Resource System (HERC) 
• 
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) 
• 
Patient-Reported Outcomes Measurement Information System (PROMIS 
• 
Pragmatic clinical trial (PCT) 
• 
Primary care provider (PCP) 
• 
Protected health information (PHI) 
• 
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) 
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• 
VA integrated service network (VISN) 
• 
VA Puget Sound Health Care System (VAPSHCS) 
• 
Veterans Affairs (VA) 
• 
Veterans Health Administration (VHA) 
• 
VHA Support Services Center (VSSC) 
• 
Veterans Health Information Systems and Technology Architecture web (VistAWeb) 
 
 
 
 
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1.0 
Study Personnel 
 
Name/ 
Contact 
Role/ 
Affiliation 
Access 
PHI 
Recruit- 
ment 
Surveys/ 
Interviews 
Data 
Analysis 
David H. Au, MD, MS 
   david.au@va.gov 
Co-Investigator (key) 
VA Puget Sound  
Y 
N 
N 
Y 
Anna Baron 
   Anna.baron@cuanschutz.edu 
Biostatistical consultant 
VA Eastern Colorado Health Care System 
N 
N 
N 
N 
Margaret Collins, PhD 
   margaret.collins@va.gov 
Project Manager 
VA Puget Sound 
Y 
Y 
Y 
Y 
Lucas Donovan, MD 
   Lucas.Donovan@va.gov 
Co-Investigator 
VA Puget Sound 
Y 
N 
N 
Y 
Eric Epler, BS  
   eric.epler@va.gov 
Coordinator 
VA Puget Sound 
Y 
Y 
Y 
Y 
Emily Gleason, BS 
    Emily.gleason@va.gov 
Coordinator 
VA Puget Sound 
Y 
Y 
Y 
Y 
Katherine Hoerster, PhD, MPH 
   katherine.Hoerster@va.gov  
Principal Investigator (key) 
VA Puget Sound  
Y 
Y 
Y 
Y 
Rachel Hunter-Merrill 
   Rachel.Hunter-merrill@va.gov 
Analyst 
VA Puget Sound 
Y 
N 
N 
Y 
Jun Ma, MD, PhD 
   maj2015@uic.edu 
Co-Investigator for Implementation oversight 
University of Pittsburgh: IPA 
N 
N 
N 
N 
Elizabeth Mattox, AARNP 
   Elizabeth.mattox@va.gov 
Co-Investigator 
VA Puget Sound 
Y 
N 
N 
N 
Jennifer McDowell, MS  
   jennifer.mcdowell@va.gov 
Coordinator 
VA Puget Sound 
Y 
Y 
Y 
Y 
Brianna Moss, BS  
   Brianna.moss@va.gov 
Coordinator 
VA Puget Sound 
Y 
Y 
Y 
Y 
Tanya Nguyen 
  Tanya.Nguyen@va.gov 
Coordinator 
VA Puget Sound 
Y 
N 
Y 
Y 
Robert Plumley  
   robert.plumley@va.gov 
Programmer 
SIBCR: VA WOC 
Y 
N 
N 
Y 
Peter Rise, MS 
   peter.rise@va.gov 
Biostatistician 
VA Puget Sound 
Y 
N 
N 
Y 
Mary Schooler 
   Mary.Schooler@va.gov 
Coordinator 
VA Puget Sound 
Y 
N 
N 
Y 
Linnaea Schuttner, MD 
   Linnaea.Schuttner@va.gov 
Co-Investigator 
VA Puget Sound 
Y 
N 
N 
Y 
Edwin Wong, PhD 
   Edwin.wong@va.go 
Co-Investigator 
VA Puget Sound 
Y 
N 
N 
Y 
 
 
2.0 
Introduction 
2.1 
Background 
More than a third of Veterans in primary care are obese,1 which was cited in 2004 by the undersecretary as the 
single greatest modifiable “health risk...even surpassing the adverse effects of smoking.”2 Losing even modest 
amounts of weight reduces the risk of multiple chronic conditions.3 In 2006, National Center for Health 
Promotion and Disease Prevention (NCP) developed and disseminated MOVE! Weight Management Program 
for Veterans (MOVE!), which is primarily an in-person group lifestyle intervention that combines evidence-
based diet and physical activity counseling with behavior change strategies.4,5 Despite being in place for nearly 
a decade, the reach of MOVE! has been low, with <5% of Veterans who are eligible for the program 
participating in one or more sessions, and with only modest weight loss on the order of 1.3 and 0.9 pounds 
more than nonparticipants after six and 12 months, respectively.6 As described below, NCP is exploring 
alternative ways of delivering MOVE! and other weight loss interventions in order to improve its reach and 
adoption for population-based weight management among Veterans with obesity. NCP’s overall goal is to 
develop a suite of programs that meet the diverse needs and preferences to optimize reach and adoption 
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among different segments of Veteran populations, as “one size does not fit all.” With input and support from the 
NCP, we propose this PCT that tests whether a low-tech, low-resource, self-directed lifestyle intervention is 
more effective at improving weight and physical function than the standard of care for Veterans with obesity, 
providing an evidence base for adoption by VA if proven successful. 
 
VA’s existing weight loss program is unable to meet the diverse needs of Veterans with obesity:5 The current 
iteration of MOVE! is the result of a decade of implementation, evaluation, and refining. The program structure 
is complex, relatively resource intensive and concentrated within larger medical facilities and selected CBOCs. 
Enrollment relies on provider referral and patient self-referral. Participants meet with their primary care provider 
and/or a MOVE! health team member to set a few specific, short-term, self-directed goals. Veterans are 
encouraged to participate in the 16 in-person weekly group-based sessions that provide education and support 
for goal setting and monitoring. The intensity and dissemination of the intervention limits the number of 
participants at any given time. NCP acknowledges that given the magnitude of the obesity problem among 
Veterans, providing Veterans with choices about how to engage in a suite of obesity treatment approaches, 
including those outside medical facilities, is likely to expand the reach of obesity treatment and possibly 
increase availability of in-person visits for those who may require that format.  
 
Heterogeneity in MOVE! facility level adoption: The initial program was pilot tested at 17 VHA facilities starting 
in 2002. A revised program was launched VA-wide in 2006. By 2010, MOVE! had been implemented at every 
VHA hospital facility and more than 50% of CBOCs, and about 95% of Veterans were screened for obesity.7 
Facility-level MOVE! utilization rates ranged from 0.05% to 16%.6,8 Leadership engagement, program staffing, 
space and equipment, engagement of champions, and communications with multi-disciplinary teams were 
identified as key elements in a facility’s ability to implement and maintain a MOVE! program.7,9 Beyond being 
able to improve access to weight loss interventions, providing Veterans effective weight loss programs that are 
inexpensive and can be managed outside a medical facility has a number of potential benefits to Veterans and 
the healthcare system. Having a program that is independent of facility personnel hiring, administered at a 
VISN, regional or central level, and does not require intensive personnel support may in fact decrease demand 
on local resources, leading to improved wait-times and access for in-person participation. Moreover, being able 
to provide these resources using a low-cost, low technology requiring program may enhance eventual 
implementation at a national-level.  
 
Heterogeneity in participation and patient outcomes associated with MOVE! Using data collected from clinical 
record measurement, Dahn et al.10 and Romanova et al.11 found that MOVE! participants lost on average 1.6-
2.2 kg up to one year after enrolling, compared to an average gain of 1.4-2.0 kg per year pre-enrollment.10,11 
The slope for weight change differed significantly during the pre- and post-enrollment periods among MOVE! 
participants, suggesting a beneficial treatment effect. Others have found that more intensive engagement in 
the program resulted in more weight loss.6,7 Using weight measurements obtained from VHA databases for the 
years 2006-2010, Kahwati et al. found that 18.6% of Veterans who attended two or more MOVE! visits lost at 
least 5% (clinically meaningful) of their body weight after 6 months, compared to 31.6% of those who had more 
intense, sustained involvement, compared to12.5% of those not involved in MOVE!. However, even as late as 
2012, within VISN 20, less than 5% of all patients who were overweight and obese participated in MOVE!.6 
Greater distance to facility and lower number of primary care visits was associated with lower enrollment in 
MOVE!. Because of the geographic distances encountered in the Pacific Northwest, the authors attributed the 
limited reach of the program, in part, to the in-person group component. In addition, patients who have a higher 
body mass index (BMI) or who already experienced obesity-related comorbidities such as diabetes and 
hypertension had higher MOVE! utilization, suggesting that the program may not be used as much for primary 
prevention. As a result, the overall public health impact of MOVE! has been constrained though could 
potentially be expanded by having a diverse suite of interventions available to address facility and patient level 
barriers.  
 
NCP is seeking new methods to reach and engage Veterans, including low-tech approaches. NCP has begun 
to pilot a number of alternative delivery modalities to address barriers to MOVE!’s implementation including 
MOVE! Coach, which provides an iPhone/iPad app that guides Veterans through self-management tools over 
19 weeks; home telephone messaging; interactive voice response for coaching messages via phone; and 
MOVE! Telephone LifeStyle Coaching, which involves regular coach telephone contact. Specialty consultation 
is available for Veterans with more specialized needs. An ongoing pilot comparing a VA-adapted Diabetes 
Prevention Program (DPP) to MOVE!, both delivered in in-person groups, among Veterans with diabetes 
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suggested promising results for the VA-DPP over MOVE!,12 possibly in part because the VA-DPP group 
sessions were of fixed-length, closed-group, and used a single lifestyle coach.  NCP is also piloting the VA-
DPP program for online delivery. However, considering the relatively low uptake of the use of My Health-E Vet, 
relying on smart phone technology and online engagement is likely to engage those who are younger, more 
technology savvy and have higher incomes.13 Given the wide variety of Veterans’ situations and needs, some 
may achieve weight loss with in-person group visits or by internet and mobile technology-intensive programs, 
while the 41% of Veterans who use VA health care who do not have access to internet14 may be better served 
with a self-directed program that uses minimal technology. NCP has identified low-technology, self-directed 
approaches as an important gap in its portfolio of weight loss programs under evaluation. The current study is 
a self-directed, low technology DVD Lifestyle Intervention (DELITE). It modifies the self-directed arm of the E-
LITE intervention that was effective in a community-based, non-VA primary care practice.15  
 
Framework: The DPP-based and the E-LITE interventions were grounded in social cognitive theory and have 
been demonstrated to be effective among patients at high risk of developing type 2 diabetes and in primary 
care clinics of largely privately insured populations. Based on strong evidence from the E-LITE trial, we 
designed the current pragmatic study using the Institute for Healthcare Improvement (IHI) Triple Aim to guide 
our application. The Triple Aim provides a system-level framework to optimize health system performance by 
simultaneously addressing three interdependent dimensions targeting the: (1) patient experience of care; (2) 
population health; and (3) per capita cost of health care (Figure 1). The VA adopted this model and it is 
required reading for all VA healthcare leaders; how DELITE aligns with the three dimensions follows. 
Experience of Care. From the patient experience, the self-directed, remotely delivered approach provides the 
opportunity to bring a potentially effective weight loss program into the homes of Veterans. DELITE increases 
opportunity for participation because its remote delivery eliminates travel distance and time or inconvenience 
such as having to take time off from work. In addition, as described above and further in Sections 2.3.1 and 
5.1, Veterans participating in DELITE will have patient-centered flexible options to access and engage with 
intervention components. Population Health. Patient eligibility targets all 
Veterans who are obese, and patient participation is not dependent on 
the Veteran being seen in the clinical context. DELITE is designed to be 
practical and scalable. The approach lends itself to central 
implementation approach common for a number of telehealth initiatives, 
and exploits the VA data infrastructure for identification and recruitment 
of patients. DELITE reaches Veterans without access to or self-efficacy 
with internet use. For those who prefer, DELITE DVDs are available 
online. Per Capita Cost.  The DVD is ~$10/person. With a single FTE 
lifestyle coach to manage these patients across multiple states/regions, 
this will be a low-resource intervention per capita. This model will also 
shift burden away from local behavioral therapists by expanding their 
availability to others who would benefit from in-person programs. 
 
 
2.2 
Significance 
According to the 2014 VA/DOD Clinical Practice Guideline update on management of overweight and obesity, 
61-83% of Department of Defense (DoD) beneficiaries and 78% of Veterans were overweight or obese, 
resulting in an estimated excess cost of $370 per patient per year in additional medical and non-medical 
costs.16 Translated to the VA primary care population of approximately 5 million Veterans equates to an 
annualized excess cost of nearly $2 billion. In 2013, of the 4,869,451 Veterans who had a height and weight 
available, slightly more than 4 in 10 Veterans were obese. In addition to the commonly associated conditions 
including diabetes, hypertension, and cardiovascular disease (CVD), obesity is likely the primary risk factor for 
non-alcoholic fatty liver disease, estimated to be as high as 40% of the US general population and which has 
surpassed alcohol, and is likely to surpass hepatitis C, as the leading cause of liver transplantation in the next 
decade.17-20 Finally, Dr. Au, the Principal Investigator (PI) and colleagues, have shown that obesity commonly 
leads to dyspnea and misdiagnoses of chronic obstructive pulmonary disease (COPD) leading to unnecessary 
care, such as inhaled corticosteroids that increase risk of pneumonia and yet provide no benefit.21-26  
As noted in the VA/DOD clinical practice guideline update, “comprehensive lifestyle intervention is the 
foundation of treatment for overweight and obesity” as a part of personalized proactive Veteran-driven care. 
 
Figure 1 
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The best practice strategies recommended in this document include the combination of dietary, physical 
activity, and behavioral components that lead to gradual and consistent energy deficits of 500-1000 kcal/day 
for effective weight loss, which are embedded in DELITE. In addition, the guideline acknowledges that 
although effective in primary care settings, clinicians often do not aggressively address excess weight with 
their patients, hypothesizing that the etiology is often complex and due to “limited availability of the multi-
component resources needed for treatment.” 
 
The express purpose of this pragmatic study is to provide the evidence needed for deciding whether a low-
cost, low-technology, self-directed program can be used effectively to expand the treatment of obesity to a 
population-based level, improving access to obesity treatment regardless of Veteran place of residence and 
access to or familiarity with information technology. This study seeks to inform whether expending VA 
resources toward implementation is warranted by assessing the program’s overall potential reach and 
effectiveness. By comparing DELITE to usual care, we address the question “how does the intervention 
compare to what we are doing now?” The usual care in VA includes the MOVE! program although the uptake 
has been relatively low. A head-to-head comparison of DELITE and MOVE! does not address our research 
question and would be of limited utility for the ultimate decision-making about program adoption because these 
interventions are likely suitable for different segments of the population. Even modest expansion of the reach 
of obesity treatments to Veterans through an alternative delivery model, as in DELITE, would have the 
potential to reduce the incidence of diabetes and reduce need for hypertensive or other medications. 
Moreover, our project seeks to address this epidemic using a low cost, low-technology approach that would 
greatly facilitate the ability to expand this intervention if found to be effective. Finally, as we noted previously, if 
effective, this product could be one additional intervention that is incorporated into a suite of interventions 
offered as part of the MOVE! program. These various interventions could be offered based on Veterans’ 
preferences, level of comfort with technology, economic abilities or distance to VA. 
 
2.3 
Preliminary Studies/Gaps in Knowledge 
 
2.3.1 Predecessor to DELITE:  
DELITE was adapted from Dr. Ma’s E-LITE self-directed intervention that translated the original DPP lifestyle 
intervention for obesity management in a non-VA primary care setting.  
Table 1 demonstrates the progression and adaptations from DPP to the current trial. The landmark DPP trial 
established the gold standard in diabetes prevention by demonstrating that an intensive lifestyle intervention 
targeting modest weight loss and increased physical activity markedly lowered type 2 diabetes incidence (by a 
mean of 58% net of control) among high risk adults across all age, sex, and race/ethnicity subgroups,27 and the 
benefit persisted for at least 10 years.28 Weight loss was the dominant predictor of reduced diabetes risk where 
every kilogram of weight loss resulted in a 16% reduction in risk.29 Despite the enormous benefit of DPP on 
diabetes risk, the lifestyle intervention was highly intensive and did not readily lend itself to implementation in 
clinical practice. To promote dissemination and implementation, DPP investigators at the University of 
Pittsburgh (UP) adapted the resource intensive, primarily one-on-one lifestyle intervention to a group program 
with fewer sessions called Group Lifestyle Balance (GLB),30-33 which is a Centers for Disease Control and 
Prevention (CDC)-recognized national DPP translation program.34 The program has shown effectiveness for 
weight and cardiometabolic risk reduction in a number of uncontrolled and controlled translation studies 
implemented using existing staff (e.g., dietitians, lay health educators) in varied community settings (e.g., 
Table 1.  Evolution of weight loss intervention programs that have resulted in D-ELITE 
Study/Program 
Brief Description 
DPP Trial 
Multicenter efficacy trial that demonstrated the superiority of the DPP lifestyle intervention to 
metformin and to placebo.  
GLB program 
Direct adaptation of the DPP lifestyle intervention which is recognized by the CDC National DPP 
initiative and being disseminated through the UP Diabetes Prevention Support Center (DPSC). 
E-LITE trial 
Randomized clinical trial in primary care integrating the GLB core curriculum with Heart360.org. 
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. 
D-ELITE trial  
Pragmatic trial building on E-LITE DVD-based intervention, evaluating effectiveness among 
Veterans.  
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primary care practices, urban medically under-served, rural, senior centers, Hispanic Women Infant and 
Children clinics, and African American churches).30,31,35-41 One of these studies, a randomized controlled trial 
(RCT) in 8 rural communities, found that the GLB program led to comparable weight loss and cardiovascular 
risk factor control regardless of the delivery modality (face-to-face, DVD, internet, or self-selection of any of the 
3 modalities).38 Another study showed an intervention combining the GLB-DVD and telephonic lifestyle 
coaching was effective in a primary care practice.31 The GLB-DVD is available in English with Spanish 
subtitles.  
 
Briefly, E-LITE was a 3-arm RCT (n=241) that sought to compare the efficacy of a highly portable and 
inexpensive self-directed lifestyle intervention to a more intensive coach-led group intervention and to usual 
care for clinically significant weight loss among adults who were overweight or obese with prediabetes and/or 
metabolic syndrome. The E-LITE study protocol42 and the primary15 
and 5 additional publications43-47 detail the design, methods, and 
outcomes. The E-LITE self-directed intervention adapted the DPP 
to have three core components: following a single group 
orientation, participants received a set of take-home DVDs and 
corresponding handouts containing 12 weekly sessions (~25 min 
ea. Table 2). The content focused on healthy eating, physical 
activity, and behavior change,48 plus online self-monitoring of 
weight and physical activity and online access to a trained 
lifestyle coach. The American Heart Association (AHA) 
Heart360.org online platform provided a free, secure patient portal 
for self-tracking (e.g. physical activity and weight), messaging 
between participant and coach, and text messaging for automated 
reminders. Dr. Ma and others have successfully used this platform 
in research-
based 
interventions.49,50  Ten additional handouts used with 
the original DPP program also were provided as an 
additional resource as desired. 
 
In comparison to usual care, both self-directed lifestyle 
intervention and intensive coach-led group intervention 
produced comparable clinically significant weight loss 
over 2 years among  adults who were overweight or 
obese with prediabetes and/or metabolic syndrome 
(Figure 2). This finding has important implications 
because weight regain is common in weight loss 
interventions, whereas weight loss maintenance for at 
least 2 years is a strong predictor of continued 
maintenance success.51,52 The self-directed 
intervention also led to significantly lower waist 
circumference and fasting plasma glucose, 
compared with usual care.15 A post-hoc analysis of 
E-LITE data found that mean (SD) change in the SF-
12 physical component scores improved by 1.6 (4.7) 
in the self-directed intervention versus a decline of 
0.4 (6.5) in the usual care control group (p = .01) and 
an increase of 0.7 (8.5) in the coach-led intervention 
(p = 0.51). In addition, increasing physical 
component scores were significantly correlated with 
weight loss in both interventions (Figure 3). The 
difference in physical component score change 
between the self-directed intervention and usual care 
(2.0; 95% CI, -0.1 to 4.0) was 4% of baseline 
(baseline M [SD], 50.5 [7.5]); 3% was the minimally 
important difference used in the DPP.53 The SF-12 mental health scores changed slightly in both intervention 
Table 2. DVD session topics 
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 
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groups and did not differ significantly from usual care. These findings are consistent with the DPP and other 
behavioral weight-loss intervention studies.53-55 They further demonstrate the favorable outcomes of the E-LITE 
self-directed intervention. As the first RCT that successfully translated the DPP-GLB lifestyle intervention into 
primary care in the U.S., E-LITE was cited as key evidence in the 2014 USPSTF behavioral counseling 
recommendations for CVD prevention in primary care.56  
 
In sum, compared with usual care, the E-LITE self-directed intervention led to significant reductions in body 
weight and cardiovascular risk factors that were sustained through 2 years, and a clinically meaningful, albeit 
statistically nonsignificant, increase in physical health status despite a normal baseline. Dr. Ma continues to 
extend her work examining the effects of integrating the E-LITE self-directed intervention for adults in primary 
care (R01 HL119453), comorbidities (depression, coronary disease and asthma), populations (Latinos, R01 
HS022702), and diverse care delivery systems (multispecialty group practice, HMO and safety net).  
 
To improve the E-LITE self-directed 
intervention for ease of participation 
among Veterans, DELITE will replace the 
single group-orientation session with a 
telephone-based visit, and will offer 
participants options for how to engage 
with the intervention subsequently: DVD 
or online access to the same 12-session 
videos, self-monitoring using paper 
booklets or MyFitnessPal (MFP), and 
coach access via MFP secure messaging 
or by phone. For weight loss, research 
has shown the method of self-tracking is 
less important than the actual process of 
self-tracking behavior itself.57 Telephone-
based lifestyle coaching is recommended 
in the latest obesity treatment guideline.3 
Adding these options improves flexibility of 
delivery and, potentially, participant 
engagement and outcomes, including for 
Veterans who do not readily engage in 
technology. Table 3 summarizes the key 
modifications incorporated into the 
proposed DELITE intervention.  Building on their strong collaborations including a recently funded NIH clinical 
trial (U01HL128868) examining weight loss for patients who were overweight or obese with COPD, Drs. Au 
and Ma seek to examine in a PCT the broad-scale effectiveness of the self-directed approach among Veterans 
with obesity in the proposed intervention, DELITE.  
 
There is a national call for the provision and coverage of multicomponent lifestyle interventions for obesity in 
primary care settings.58,59 The challenge historically with such interventions is that they are often too intensive 
to implement in the real world. The Centers for Medicare and Medicaid Services reimbursement policy 
promotes brief (15 minutes), lower-intensity (compared with efficacy studies), face-to-face behavioral 
counseling within a limited timeframe (i.e., 6-12 months).59 The DELITE intervention (see Tables 2 and 3 
above) fits this general pragmatic framework with likely better efficiency due to use of a self-directed approach 
with remote delivery and low staffing requirements. The current study will contribute to the evidence base 
needed to inform and guide policy change, in the context of growing interest and evidence in effective and 
pragmatic interventions. 
 
2.3.2 Experience with using Clinical vs Research Measured Weights: 
Table 3. Original E-LITE self-directed and D-ELITE intervention 
components summary 
 
E-LITE self-directed 
D-ELITE 
 
Patients with prediabetes/Metabolic 
syndrome 
Veterans with obesity 
 
One-time initial group based in-
person orientation 
One time telephone orientation 
 
Take-home DVDs with participant 
handouts for 12 weekly sessions 
(~25 min ea.) (cost: $10 a set)  
Mailed DVD with participant 
handouts for 12 weekly sessions 
(~25 min ea.) (cost: $10 a set) 
 
Recommended daily self-
monitoring of weight and physical 
activity via Heart360; participants 
entered weights and minutes of 
physical activity and pedometer 
steps, if available (cost: free) 
Recommended daily self-
monitoring of weight and physical 
activity via MyFitnessPal or 
paper tracker; participants enter 
weights and minutes of physical 
activity (cost: free) 
 
Access to a trained lifestyle coach 
for questions and counseling, at 
participant request, via online 
secure messaging (cost: minimal 
coach time-average 2 
messages/month/participant) 
Access to a trained lifestyle coach 
for questions and counseling, at 
participant request, via secure 
messaging or telephone (cost: 
minimal coach time- average 2 
messages/month/participant) 
 
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Using a similar approach to what we propose in DELITE, E-LITE compared the differences in slope between 
clinically and research measured weights to examine whether clinically obtained weights would lead to a 
different conclusion.15,42 Table 4 shows both intervention arms had significant weight loss whereas the usual 
care arm did not.  Moreover, slopes obtained from in-clinic and research measured weights were not 
statistically different.  This finding 
was replicated in a separate weight 
loss intervention study, BE WELL,60,61 
which involved a different health 
system and patient population than 
E-LITE.  Collectively, these results 
demonstrate that there would have 
been no difference in interpretation 
of these two interventions using 
either clinic or research weights.   
 
 
3.0 
Objectives 
The overall goal of this trial is to produce evidence on the effectiveness of a proven, pragmatic lifestyle 
intervention targeted at modest, clinically meaningful weight loss and increased physical activity among 
Veterans with obesity. In this simple, pragmatic clinical trial (PCT), and with input from the National Center for 
Health Promotion and Disease Prevention (NCP), we focus on the intervention’s reach and its effectiveness on 
weight loss and generic health-related quality of life (HRQoL). We will examine secondary aims that include 
physical activity, sedentary behavior, dietary intake, blood pressure, sleep quality and self-efficacy. With 
success framed in reach and effectiveness, this VA-based PCT tests a low-cost, low-resource, behavioral 
weight loss intervention previously shown to be effective in non-VA primary care settings. 
 
3.1 
Scope of Problem to be Addressed 
• 
Obesity is common; ~1/3 of Veterans in VA integrated service network (VISN) 20 and beyond are 
obese. 
• 
As a preventable health risk, obesity and sedentary lifestyle surpass the prevalence and adverse 
effects of tobacco smoking. 
• 
The MOVE! Weight Management Program for Veterans (MOVE!), developed by NCP, produces 
modest weight loss among those who participate. However, participation is currently limited to <5% 
of eligible Veterans. NCP is seeking approaches that improve the reach of obesity programs to 
more Veterans. 
• 
The Blueprint for Excellence prioritizes the need to improve timely and efficient access to proven 
effective therapies for all Veterans by overcoming diverse geographic and technology-based 
barriers to care. 
• 
The medical facility-focused care delivery model that requires in-person visits to VA facilities (both 
medical centers and outpatient clinics) limits reach and access to care based on distance and 
staffing availability. 
• 
Multiple medical conditions compete with obesity for recognition and treatment in primary care. 
 
3.2 
Challenge 
• 
Improve access to lifestyle interventions using a patient-centered and population-based approach. 
• 
Provide obesity services to a diverse Veteran population through a broad selection of modalities. 
• 
Overcome barriers to MOVE!’s population health impact for Veterans highlighted by VISN 20 
evaluation:1. 
• 
Low reach: <5% of Veterans eligible for MOVE! have used the program. Reach was likely limited by 
a number of factors, including: Distance with ~50% of Veterans living >30 miles from a local VA 
medical center or community based outpatient clinic (CBOC); Provider or patient self-referral 
enrollment system leading to differential participation based on the frequency of exposure to 
healthcare providers; Selection biases of patients who already experienced complications of obesity 
Table 4. Difference in slope between clinic and research measured weights 
from two separate clinical trials of weight loss   
  
Number  Clinic 
(slope) 
Research 
(slope) 
Slope difference 
(95% CI) 
p-
value 
E-LITE  
  
  
  
  
Self-directed  
81 
-0.05 
-0.11 
0.06 (-0.03, 0.15) 
0.17 
Coach-led  
79 
-0.11 
-0.12 
0.01 (-0.07, 0.08) 
0.85 
Control  
81 
0.0 
0.01 
-0.01 (-0.09, 0.06) 
0.74 
BE WELL  
 
 
 
 
 
Coach-led  
165 
-0.02 
-0.04 
0.02 (-0.01, 0.06) 
0.21 
Control  
165 
0.0 
-0.02 
0.02 (-0.02, 0.06) 
0.43 
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were more likely to participate in MOVE!, which limits its potential for population health 
management. 
• 
Heterogeneous adoption: A 14-fold variation in program use between VA medical centers among 
MOVE! eligible patients due to limitations of available resources and competing demands. 
• 
Modest effectiveness among users: In-person MOVE! sessions at a VA facility constrains program 
effectiveness. Among Veterans who used MOVE!, ~50% had only one program encounter resulting 
in small amounts of weight loss of 1.3 lb (95% CI,−2.6 to −0.02 lb) and 0.9 lb (95% CI, −2.0 to 0.1 
lb) at 6 and 12 months, respectively. Participating in six or more sessions resulted in greater weight 
loss at 12 months (−3.7 lb; 95% CI, −5.1 to −2.3 lb). Additionally, 15% of MOVE! enrollees lost 5% 
or more body weight, while 11% gained more than 5% of body weight.2 
 
3.3 
Opportunity 
• 
The Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care 
(E-LITE) compared two active interventions with each other and usual care.42  Adapted from the 
Diabetes Prevention Program (DPP) lifestyle intervention,27 the two E-LITE interventions were 
designed for primary care delivery through coach-led, in-person groups or self-directed-video with 
the option of remote coach support. 
• 
The self-directed intervention46,62 was effective, simple, pragmatic and comparable to the group-
based intervention and superior to usual care (at 2 years: Mean [s.e.], –4.5 [0.9] kg; 44% with >5% 
weight loss). These results informed and were incorporated into the 2014 United States Preventive 
Services Task Force (USPSTF) guidelines for behavioral counseling for CVD prevention in primary 
care.56 
• 
We will implement the E-LITE self-directed intervention (now called DELITE) in a patient-level 
randomized PCT of 500 Veterans with obesity. Our specific aims are to test whether, compared 
with usual care (UC) controls, intervention participants have better outcomes, including: 
 
1. Primary measures: Greater weight loss and improved physical function through 12 months. 
2. Secondary measures: Improvements in sustained weight loss, physical function and activity, 
sedentary behavior, diet quality, blood pressure, sleep quality, self-efficacy, and reach of the 
program to participants with obesity through 24 months. Budget impact analyses to aide NCP in 
decision making about potential dissemination. 
 
3.4 
Impact  
Effective, pragmatic obesity treatment will address the most common preventable cause of disease in VA, 
having high clinical and public health importance. 
 
 
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 
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DELITE is a simple, two-arm PCT 
in which 500 Veterans with obesity 
will be randomized to usual care 
(UC) or UC plus the DELITE self-
directed lifestyle intervention for 12 
months. We will assess weight 
change from baseline via CDW 
over a 24-month period and self-
report assessment at 12 and 24 
months. We hypothesize that 
intervention participants will have 
more weight loss and greater 
improvements in self-reported physical function at 12 months relative to UC controls. The design is depicted in 
Figure 5 and described below.  
 
5.2 
Recruitment Methods 
 
5.2.1 Enroll Veterans within the Pacific and Mountain Time zones:  
This broad area includes urban, rural and very rural areas, while allowing the lifestyle coach to retain normal 
working hours. 
 
5.2.2 Identify Eligible Participants through CDW:  
Before we begin recruitment, we will refine our algorithms that we will apply to CDW data to identify potentially 
eligible participants within the past year and verify with chart review.  
 
5.2.3 Screening for Index Weight/BMI:  
Using CDW, we will identify Veterans who had a primary care visit with an eligible BMI (index weight), a weight 
measurement in the previous 12 months 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 will oversample: 
• Women – our goal is to enroll approximately 30% of the cohort being women; 
• Minorities, if necessary, to have a balanced proportion of the cohort; 
• At VA Puget Sound HCS/CBOC’s for study staff to obtain in-person weights for approximately 50 
participants should the study team determine it is necessary to validate clinic weight measurements. 
 
5.2.5 Research Invitation:   
Using patients identified through CDW, we will mail invitations to enough Veterans to enroll 500 Veterans with 
obesity. The invitation packet will contain:  
• 
Invitation Letter; 
• 
Information Sheet; 
• 
Opt in/out Post Card; 
• 
Copies of Baseline Surveys with optional postage-paid return envelope. 
We will pursue the option of posting the packet on the HSR&D public website for easy access in the future. 
 
Once we meet our randomization goal, we will inform participants who have opted-in but are not yet 
randomized that enrollment is closed.  
 
 
5.3 
Informed Consent and Randomization 
5.3.1 Telephone Screen, Consent, and Baseline Assessment:  
Figure 5.  Overall study flow 
Identify 
obese patients 
in CDW 
(Baseline 
weight)
Telephone 
Oral consent, 
eligibility 
screen, self-
report baseline 
measures
Email PCP for  
clearance
12-month 
lifestyle 
intervention
Usual care
12 & 24 
months: 
CDW and 
self-
report 
outcomes
Randomize
n=250
n=250
Mail 
invitations 
and opt-out 
postcards
24 Months
(12 months intervention, 12 months follow-up
Nightly 
interrogations
Weekly batch 
mailings
Completed within 
12 weeks of 
baseline weight
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For those potential participants who do not return an opt-out postcard within 2 weeks (or who return the opt/in 
card), 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 paper copies and return via postage-paid mail. 
• Baseline assessment must occur no more than twelve weeks after the date of the index weight. 
 
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 day unless they contact us 
otherwise.  We will inform interested participants if their provider responded that this intervention is not 
appropriate.   
 
5.3.3 Randomization:   
DELITE staff will perform stratified randomization into the usual care or intervention group at a ratio of 
1:1 within strata defined by age (<65 vs. ≥65), BMI (three categories: ≥30 and <35 vs. ≥35.0 and <40 
vs. ≥40.0 and <45), and population density (Rural vs. Urban). Randomization mush occur no more than 
twelve weeks after the date of the index weight. We will notify participants of their randomization group 
via mail.  The mailing will include a weight scale, water bottle with a DELITE logo for all participant and 
the intervention materials (DVDs, binder containing introduction/instructions and the GLB curriculum, 
scale, CalorieKing Fat & Carbohydrate Counter, and paper tracking booklets) for intervention 
participants. 
 
5.3.4 Continuation of Usual Care: 
All participants will continue to receive standard medical care from their usual providers. The study will not 
interfere with ongoing patient care, including provider or patient referral to MOVE! or other available weight 
loss interventions. To account for changes in medical practice and secular trends and to protect external 
validity, no participant will be restricted from seeking or instructed not to seek weight loss treatment once 
enrolled and will be included in the intent-to-treat analyses.  
 
5.3.5 Intervention:  
 
5.3.5.1 Evidence-based intervention goals:  
Weight: The intervention is designed to achieve and maintain a weight loss of 5-10% of baseline body weight 
in a gradual stepwise fashion. This amount of weight loss is safe, feasible and associated with clinically 
significant reductions in the risk of diabetes and cardiovascular disease such as hypertension.27,63-65 To help 
achieve and maintain the weight goal, participants are advised to reduce their calorie intake by 500-1000 
kcal/day, as recommended in adult obesity guidelines, including the recent VA DOD clinical practice 
guideline.66 Participants will gradually achieve the calorie goals through portion control, choices of low-energy 
and nutrient-dense meals and snacks (e.g., whole fruit, vegetables, whole grains, and low-fat, non-sweetened 
dairy products), reduced consumption of refined and/or added 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 (such as brisk walking). This goal is consistent with the 2008 Physical 
Activity Guidelines for Americans,67 and is deemed 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 2). Participants may 
also choose to adopt regular activities of moderate intensity other than brisk walking.68,69 After attaining the 
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minimum goal of 150 minutes per week, participants may choose to be more active; or if participants reach the 
150-minute goal but are not achieving the weight goal, they will be encouraged to further gradually increase to 
60 minutes/day of moderate physical activity61,68,70 while continuing to work on dietary changes. 
 
5.3.5.2 Intervention format, structure, and content.  
Within two weeks of randomizing a participant to the intervention group, a DELITE lifestyle coach will call to 
confirm receipt of the intervention package, review the materials and instructions, confirm understanding, and 
address any questions.  
 
The DELITE core curriculum consists of watching one ~25-minute GLB video session (see Table 2 for list of 
topics) each week for 12 weeks, and using a corresponding GLB handout. The GLB also includes additional 
“Physical Activity Resource” videos with a corresponding handout. Participants may watch the sessions on 
DVD or online through the University of Pittsburg GLB training center. The lifestyle coach will instruct 
participants about how to use the MFP website or paper-tracking booklets, depending on preference, for self-
monitoring which may include weight, food intake, physical activity, GLB materials used, and how to contact 
the lifestyle coaching via MFP secure messaging or phone if they have questions or would like guidance with 
the lifestyle program. A lifestyle coach will send standardized reminders through MFP secure messaging or via 
mail for participants who choose to use paper trackers. As recommended by guidelines, the main objective of 
the core curriculum 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, and use of 
additional GLB handouts. Participants will have access to a lifestyle coach via MFP secure messaging or 
telephone as desired for the 12 months of the intervention. The choice to engage with a lifestyle coach is 
strictly up to the participant and will occur as seldom or often as the participant chooses. Self-monitoring is key 
to success in behavioral weight-loss interventions.71 The lifestyle coach will continue to send standardized 
reminders throughout the 12 months of the interventions.   
 
5.3.5.3 Intervention adherence.  
Other than sending the standardized reminders (Section 5.3.5.2), DELITE will not use special strategies to 
maintain or improve participant adherence to the intervention.  
 
 
5.4 
Inclusion/Exclusion Criteria 
DELITE uses inclusion and exclusion criteria (Table 4) aimed at ensuring each participant's safety and 
maximizing internal validity, including minimizing error associated with the primary outcomes, and preventing 
possible missing data. 
Table 4. Eligibility criteria  
Inclusion 
• Primary care measured BMI ≥30 and <45 kg/m2 and BMI measured in prior week indicating obesity; 
• Able to participate fully in all study protocol/procedures including informed consent; 
• Access to DVD player or internet. 
 
Exclusion 
• Inability to speak, read, or understand English; 
• Participating in active weight loss intervention including use of prescription weight-loss medications in 
the past 3 months, current participation in group or individual weight loss programs provided by trained 
personnel, had/have 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 (ascites – liver disease, chronic heart 
failure);  
• Safety and/or adherence concerns due to severe physical or mental health issues or life expectancy <24 
months;  
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5.5 
Study Evaluations 
Table 5 shows the study measures and data collection schedule. We will send self-administered 
questionnaires to participants via mail with the option to complete and return by postage-paid mail.  If the 
participant does not return the questionnaires by mail within two weeks, we may send a reminder letter or a 
study coordinator may attempt to administer them by telephone.   To improve retention and the likelihood that 
participants will complete the follow-up evaluations, we will send a letter reminding them of their participation in 
the study at around the 4th, 8th , 16th , and 20th  month after randomization. 
 
5.5.1 Baseline Variables and Co-variates:  
We will collect baseline variables and co-variates from CDW to the extent possible, and supplement with 
participant self-report surveys, MFP logs, and/or paper trackers. 
 
5.5.2 Outcomes:  
 
• Weight: 
o For all participants, we will extract all outpatient-based weight measurements from CDW starting 
with 12 months prior index date through 27 months of follow up. For participants without a CDW 
weight: 
 
We may include a reminder with the outcomes surveys to visit their primary care clinic to be 
weighed if a clinic visit is safe and feasible. 
 
During times when a clinic visit is not feasible (i.e., currently, during SARS-CoV-2 
pandemic), we will include a self-weight form with the outcomes surveys for those without a 
CDW weight to weigh themselves at home. The self-weight survey and instructions for self-
weighing will be in lieu of a reminder to visit their clinic to avoid encouraging participants 
seeking medical care unnecessarily, given public health guidance to avoid healthcare 
settings for anything other than urgent care requiring in-person contact. All participants 
without a 24-month CDW outcome will be asked to self-weigh using a letter asking the 
participant to weigh themselves using the scales provided by DELITE at baseline. The 
mailing will include instructions about how to make the measurement (e.g., light indoor 
clothing, no shoes or other heavy items), a form to record the weight, and a postage-paid 
return envelope. If we do not receive a mailed response from participants within 2-weeks, a 
study coordinator may call the participant and ask them to weigh themselves and report the 
weight over the telephone.     
 
A participant’s primary outcome weight will be the one measured closest to 12 months  AND 
between nine and 15 months, in a primary care-based clinic, and extracted from CDW.  We 
will consider other weights as secondary outcomes. 
o To validate clinic weights, we asked some VA Puget Sound HCS/CBOC participants to visit the 
Seattle or American Lake campus for an in-person weight collected by study staff. We coordinated 
those visits with an existing clinic visit to have a clinic-based weight for comparison.  If the 
scheduled visit is in a non-primary care clinic, we may ask the participant if we may accompany 
them to primary care for a weight check.  If primary care does not enter the weight into CPRS, Drs. 
Au or Hoerster may do so. We have completed this process as of early 2020 and won’t add it again, 
given the pandemic. 
 
• 
Generic health status: Assessed using the SF-1255 at 12 months as a primary outcome and at 24 months 
as a secondary outcome.  The SF-12 has been extensively tested and shown to be valid, reliable and 
responsive to change.  
• 
Reach: We selected the most relevant measure for the present trial from the well-established RE-AIM 
framework72: “reach,” defined as the “number, proportion, and representativeness of individuals willing to 
participate in a given intervention.” First, we will estimate the proportion of those eligible who agreed to 
participate, with total recruitment letters sent, and total eligibility screenings conducted as denominators. 
• Pregnant, lactating, or planning to become pregnant during the study period; 
• Participation in other intervention studies.  
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Second, we will capture “representativeness” by comparing participants’ demographic characteristics to the 
VA patient population and to those who were eligible for the study. 
• 
Physical activity: 7-item International Physical Activity Questionnaire (short IPAQ) which evaluates weekly 
walking, vigorous and moderate-intensity activity.73  
• 
Dietary quality/self-efficacy: Starting the Conversation74 questionnaire with items pertaining to fat, fruit and 
vegetable intake, and sugar intake, as well as diet self-efficacy measures.75  
• 
Sleep-Related Disturbance and Impairment:  4-item sleep disturbance and 8-item sleep-related impairment 
scales from the NIH PROMIS measures.76 
• 
Blood pressure: diastolic and systolic values from 12 months prior index date to 27 months follow-up will be 
obtained from the CDW.  
• 
Blood sugar levels: HbA1c levels from 12 months prior index date to 27 months follow-up will be obtained 
from CDW 
• 
Other weight loss interventions: We will monitor through CDW data extraction for participation in MOVE! 
and by patient report for participation in programs outside VA, and we will control for such use in secondary 
analysis. 
• 
Engagement of participants to the intervention will be assessed by: Through MFP and/or mailed survey: 
o Number of GLB sessions viewed, modality used (DVD vs. online), and use of handouts; 
o Number and topic of contacts with lifestyle coaches.   
• 
Cost: We will conduct a budget impact analysis and determine implementation costs using VA Managerial 
Cost Account (MCA) System. 
 
 
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Table 5. Measures and timing of data collection. 
Variable 
Potential source of data 
12  
months  
prior 
Baseline 
3 
months 
12 
months 
24 
months 
 
Program reach, baseline characteristics, and covariates 
Height 
CDW 
 
x 
 
 
 
Comorbidities 
CDW/self-report 
x 
x 
 
x 
x 
Medications 
CDW 
x 
x 
 
x 
x 
Healthcare utilization 
CDW 
x 
x 
 
x 
x 
Distance from primary care 
clinic 
CDW 
 
x 
 
 
 
Demographics 
CDW; 
Self-report 
 
x 
 
 
 
Weight loss programs  
CDW/self-report  
 
 
 
x 
x 
Self-monitoring 
Self-report 
 
 
 
x 
x 
 
Outcome assessments 
Primary  
 
 
 
 
 
 
Weight  
CDW (primary care-based 
measurement through 15 
mos) 
 
x 
 
x 
 
SF-12 
Self-report 
 
x 
 
x 
x 
Secondary 
 
 
 
 
 
 
Weight 
CDW (all outpatient 
measurements* through 27 
mos) or participant measured* 
x 
x 
 
*x 
x 
Physical activity 
Self-report 
 
x 
 
x 
x 
Dietary quality/self-efficacy 
Self-report 
 
x 
 
x 
x 
Sleep disturbance / 
impairment 
Self-report 
 
x 
 
x 
x 
Blood pressure 
CDW 
x 
x 
 
x 
x 
HbA1c 
CDW 
x 
x 
 
x 
x 
Other weight loss 
interventions 
CDW/self-report  
x 
x 
 
x 
x 
Engagement 
Self-report 
 
 
x 
x 
 
Percent accepting invitation 
Invitation response 
 
x 
 
 
 
Cost** 
MCA 
 
 
 
 
x 
Reach 
CDW/self-report/study 
tracking 
 
x 
 
 
 
 
Adverse Event Surveillance 
Event form 
CDW/Self-report  
 
 
 
x 
x 
**other potential sources are Health Economics Resource Center (HERC), Non-VA Medical Care Files, VA/CMS Data for 
Research, and VHA Support Services Center (VSSC) via the following tools: Compensation & Pension Record Interchange 
(CAPRI), the Computerized Patient Record System (CPRS), VistAWeb, VINCI. 
 
 
5.5.3 Participant Payment:  
After the 24-month time point, we will compensate participants $20 for completing the 12- or 24-month survey 
packets.  We will pay participants an additional $10 if they complete both packets, for a total possible of $30. 
 
Following payment submission, we may mail a letter notifying participants that participation is complete and 
payment has been submitted. 
  
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5.6 
Data Analysis 
5.6.1 Power/Sample Size: 
This study is powered on weight and SF-12 PCS outcomes, using ANCOVA for 12-month follow-up weight 
adjusted for baseline weight, and applying a t-test for the 12-month SF-12 77. See Table 6 for a summary. A two-
sided type I error rate of α = 0.025 was chosen based on a multiple comparisons Bonferroni adjustment. In order 
to ensure adequate power for this pragmatic trial, we are enrolling 500 Veterans. 
 
We based expected outcomes in D-ELITE on clinically meaningful outcomes. Regarding weight loss, we based it 
on the weight lost in E-LITE’s self-directed arm among male participants (since we anticipate the majority of our 
Veteran participants will be male): 11 ± 2 lbs 62. This is an amount of weight loss likely to be clinically meaningful 3. 
We expect weight loss in the control condition to be similar to that achieved in the standard MOVE! program: 3.3 
pounds 78. Thus, we expect to be able to detect a 7.7-pound absolute difference in 12-month mean weight 
between treatment arms, which requires 78 patients per treatment arm (156 patients in total), assuming a 12-
month weight standard deviation of 50 lbs 79, correlation of 0.97 between baseline and 12-month weight, 90% 
power, two-sided Type I error rate α = 0.025, and 20% attrition at 12 months 62. This scenario has a Cohen’s d 
effect size of 0.154 80. A more conservative set of assumptions with a 6.7-pound difference (25% reduction in 
Cohen’s d effect size) and a weaker correlation of 0.95 between baseline and 12-month weight measures requires 
225 patients per treatment arm (450 patients in total) with all other assumptions unchanged.  
 
For SF-12 PCS at 12 months, we assume a Minimal Clinically Important Difference (MCID) of a 5.00-point 
absolute mean difference for the SF-12 PCS 81 between treatment arms, with a standard deviation of 8.88 points 
based on unpublished E-LITE data, which corresponds to a Cohen’s d effect size of 0.563 80. Also assuming 90% 
power, two-sided Type I error rate α = 0.025, and 20% attrition at 12 months, this would require 100 patients per 
treatment arm (200 patients in total). A more conservative scenario that assumes a 4.33-point absolute mean 
difference (25%-reduced effect size) requires 176 patients per treatment arm (352 patients in total) with all other 
assumptions unchanged.  
 
5.6.2 Retention: 
As in other studies, we will carefully train and regularly review with staff best practices for retaining participants, 
including fully informed roles and responsibilities of staff and participants, and conveying an appreciation of 
participation and study identification. We will train staff to conduct effective informed consent to assure that 
participants fully understand the demands and nature of the study before they enroll. Coordinators will carefully 
review study requirements with participants, explain the concept of random assignment and what each treatment 
involves, and stress the importance of follow-up assessment even if they are not adhering to their assigned 
Table 6. Sample size requirements for 12-month weight, SF-12 PCS. 
12-Month 
Outcome 
(Testing Method) 
Significance 
Level 
Power 
Scenario Type 
Mean Diff. 
(SD) 
Cohen’s d 
Sample Size 
(w/ 20% Attrition) 
Per-Group 
Total 
Weight 
 
(ANOVA, with 
adjustment for 
baseline weight) 
0.025 
0.90 
Mean Diff. = 7.7 
SD = 50.0 
Corr. b/w Baseline, 
12-Mo. Measures = 
0.97 
7.7 (50.0) 
d = 0.154 
78 
156 
Conservative 
(25% Cohen’s d 
reduction, 
Corr. = 0.95) 
6.7 (57.7) 
d = 0.116 
225 
450 
SF-12 PCS 
 
(t-test) 
0.025 
0.90 
MCID = 5.00 
SD = 8.88 
5.00 (8.88) 
d = 0.563 
100 
200 
Conservative 
(25% Cohen’s d 
reduction) 
4.33 (10.25) 
d = 0.422 
176 
352 
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treatment. We will use a database to systematically track participant activities, prompt the study team when action 
is required, and regularly produce quality control reports, all proven elements for participant retention.  
 
 
5.6.3 Hypothesis Testing and Statistical Analyses:  
We will use intention to treat (ITT) for all primary and secondary analyses. We will evaluate the dropout and 
missing data patterns for informative missingness82. To test for non-zero intervention effects on weight and SF-
12 PCS, we will compare mean outcome between intervention and control groups at 12 month follow-up using 
the repeated-measures mixed-effects linear model:83-85  
 
𝑦𝑦𝑖𝑖𝑖𝑖= 𝛽𝛽0 + 𝛽𝛽1(𝑗𝑗) + 𝛽𝛽2൫InterventionFollowUpij൯+ 𝛽𝛽3(Age65Plus𝑖𝑖) + 𝛽𝛽4(BMICat1𝑖𝑖) + 𝛽𝛽5(BMICat2𝑖𝑖) + 𝛽𝛽6(Urban𝑖𝑖) +
𝛼𝛼𝑖𝑖+ 𝑒𝑒𝑖𝑖𝑖𝑖 
 
𝑦𝑦𝑖𝑖𝑖𝑖 is the outcome (weight or SF-12 PCS) for patient i at baseline (j = 0) or 12-month follow-up (j = 1). 
InterventionFollowUp𝑖𝑖𝑖𝑖 is an indicator variable equal to 1 if patient i was randomized to the intervention arm 
and 𝑦𝑦𝑖𝑖𝑖𝑖 corresponds to a 12-month follow-up outcome (j = 1), and it is equal to 0 otherwise. Age65Plus𝑖𝑖 is an 
indicator variable for whether the patient’s age was at least 65 years at initial CDW pull. BMICat1𝑖𝑖 is an 
indicator variable for whether the patient’s BMI at initial CDW pull was ≥35 and <40, and BMICat2𝑖𝑖 is an 
indicator variable for whether the patient’s BMI at initial CDW pull was ≥40.0 and <45. Urban𝑖𝑖 is an indicator 
variable for whether the patient’s population density at initial CDW pull is urban. The adjustment for 
Age65Plus𝑖𝑖, BMICat1𝑖𝑖, BMICat2𝑖𝑖, and Urban𝑖𝑖 is based on the use of these variables in our stratified 
randomization procedure.86 The 𝛼𝛼𝑖𝑖 are patient-level random effects, independently distributed Normal(0, 𝜎𝜎𝛼𝛼2). 
The 𝑒𝑒𝑖𝑖𝑖𝑖 are measurement-level errors, independently distributed Normal(0, 𝜎𝜎2). Our primary weight and SF-12 
PCS models do not adjust for the main effect of the intervention, and the coefficient estimates for 
InterventionFollowUpij will serve as our treatment effect estimates. Our randomization is expected to promote 
equality across treatment arm with respect to our baseline outcomes and patient characteristics. Under this 
assumption, the coefficient for the main effect of treatment is expected to be zero, and our power is increased 
by excluding its estimation from our models.87 
 
We will adjust the co-primary outcome analyses for multiple testing using a Bonferroni adjustment,88 which will 
allow for individualized assessment of our two primary outcomes at significance level 0.025 while maintaining a 
familywise error rate equal to 0.05. If exactly one hypothesis test leads to a null hypothesis rejection, we will 
infer that the intervention had a significant effect on that primary outcome but not the other. Two null 
hypothesis rejections and two failures to reject are also possibilities, in which case we will infer that the 
intervention had a significant effect on both or neither of our primary outcomes, respectively. 
 
Exploratory analyses of Aim 2’s biometric, psychological, and behavioral outcomes will be examined using 
tests of mean difference between groups after adjusting for baseline measures and randomization covariates 
in linear or logistic models, drawing on models used for primary analyses. We also will examine effects among 
women, and have estimated—with the assumptions of 80% power, ICC of 0.9, and 150 women participants—
that we will have power to detect a similarly-sized effect among women as in the prior E-LITE trial.62 Given 
these outcomes are exploratory and are not focused on hypothesis testing, adjustment for multiple 
comparisons will not be performed.89 Rather, these analyses will report effect sizes and 95% confidence 
intervals, along with p-values, to aid with interpretation of clinical significance.  
 
5.6.4 Budget Impact Analysis: 
To assess the economic impact of the intervention, we will focus on budget impact analyses to establish a 
business case for future implementation if the intervention is successful.  We will perform a budget impact 
analysis from the VA perspective using a 12-month intervention period.  First, we will compare costs of care 
potentially associated with weight loss therapies between the intervention and control groups: VA nutrition and 
behavioral weight management healthcare visits and weight loss medication from the VA Managerial Cost 
Account (MCA) System and Health Economic Resource System (HERC).90,91. Second, we will estimate 
potential future D-ELITE implementation costs, combining estimated potential patients based on trial reach 
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findings with costs of identifying and recruiting patients; training lifestyle coaches; and activities performed by 
the lifestyle coach using detailed project logs, incorporating data on staff salaries.92    
 
5.6.5 Misclassification and Missing Data: 
We anticipate that any misclassification of outcome measurement will be non-differential with respect to 
randomization and effectively biasing our results toward the null. We will attempt to minimize misclassification 
by using approaches to decrease measurement error within the CDW data as well as by collecting patient-
measured data when necessary. We will use data collected from primary care clinics preferentially. We will not 
collect weight data that was part of hospital admissions because of potential of changes in weight due to 
management. We will ask participants to use the scales provided only when not available in the CDW. If we 
find no evidence of informative missingness we will be able to rely on our use of well-specified mixed models to 
test effects of the intervention as these are known to lead to valid conclusions even when data are missing at 
random (MAR).87,93 If we detect informative missing data patterns, we will apply sensitivity analyses using 
pattern mixture models.82 Complete case analysis will only be performed as a sensitivity analysis, to provide 
useful inference if the data are mostly complete and the bias introduced by dropping the small proportion of 
incomplete cases is negligible. 
 
5.6.6 Interim Analyses: 
We plan no formal interim analysis of efficacy or futility. We will provide interim safety reports semi-annually to 
the Data Monitoring Committee (DMC). 
 
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. 
 
 
6.0 
Reporting 
 
6.1 
Safety Assessment  
Physical, psychological, social, legal or other risk will be low in association with participation in the proposed 
research. We base this assertion on the original diabetes prevention program where serious adverse event 
rates were similar in the intervention and placebo groups (NEJM, 2002,346:393-403). Moreover, Dr. Ma’s 
ELITE trial showed no study-related serious adverse events in the self-directed DVD group upon which the 
DELITE intervention is based.  
 
To ensure unbiased determination across treatment arms, at each 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. A study investigator with appropriate clinical 
training and will assess (using participant self-report and chart review) each AE for duration (start and stop 
dates and times), expectedness in the study population, severity, outcome, treatment and relation to study 
activity.  
 
The following are expected adverse events in the DELITE population of participants who have 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;  
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• 
Development of weight associated disorders including diabetes, hypertension, liver disease, cardiovascular 
disease, asthma, COPD, clotting problems, and other lung related conditions;  
• 
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.  
 
  
6.2 
Quality Monitoring   
The investigators will closely monitor and prepare semiannual 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.   
 
6.3 
Data Monitoring Committee (DMC)  
This is a single-site study with minimal risks; therefore, we will form a Data Monitoring Committee (DMC) 
consisting of Charles Maynard, PhD, and Ashok Reddy, MD.  The committee will convene at least 
semiannually. 
 
Upon discovering an unexpected and related SAE, study staff will provide the IRB and DMC 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 DMC may request additional information if it deems additional 
deliberation is warranted.  
 
For all other events, staff will summarize and report to the DMC on a semi-annual basis the numbers and types 
of all AEs by unidentified treatment arms. At their discretion, the DMC may request unblinded results in order 
to determine the nature and extent of effect of the intervention.  Should the DMC 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 DMC. 
 
For semiannual reporting, staff also will provide the quality monitoring report to the DMC.  
 
At the semiannual meeting, the DMC 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.  We will not disclose the PHI outside the the VA.   
 
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. 
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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 or a paper tracker.    
 
 
8.0 
Communication Plan 
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. 
 
 
9.0 
Information Security and Data Storage/Movement 
DELITE 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, 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 information is not 
disclosed to any third party except as required by law.   
 
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.   All of 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.  
 
 
 
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10.0 References 
 
1. 
Johnelle Sparks P, Bollinger M. A Demographic Profile of Obesity in the Adult and Veteran US 
Populations in 2008. Population Research and Policy Review 2011;30:211-33. 
2. 
The Managing Overweight and/or Obesity For Veterans Everywhere (MOVE!) Program. Under Secretary 
for Health's Information Letter, IL 10-2004-014, October 7, 2004. at 
http://www.move.va.gov/docs/Resources/MoveInfoLetter.pdf.) 
3. 
Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS guideline for the management of 
overweight and obesity in adults: a report of the American College of Cardiology/American Heart 
Association Task Force on Practice Guidelines and The Obesity Society. Circulation 2014;129:S102-38. 
4. 
Kinsinger LS, Jones KR, Kahwati L, et al. Design and dissemination of the MOVE! Weight-Management 
Program for Veterans. Prev Chronic Dis 2009;6:A98. 
5. 
Kahwati LC, Lewis MA, Kane H, et al. Best practices in the Veterans Health Administration's MOVE! 
Weight management program. Am J Prev Med 2011;41:457-64. 
6. 
Littman AJ, Boyko EJ, McDonell MB, Fihn SD. Evaluation of a weight management program for veterans. 
Prev Chronic Dis 2012;9:E99. 
7. 
Kahwati LC, Lance TX, Jones KR, Kinsinger LS. RE-AIM evaluation of the Veterans Health 
Administration's MOVE! Weight Management Program. Transl Behav Med 2011;1:551-60. 
8. 
Del Re AC, Maciejewski ML, Harris AH. MOVE: weight management program across the Veterans Health 
Administration: patient- and facility-level predictors of utilization. BMC Health Serv Res 2013;13:511. 
9. 
Damschroder LJ, Goodrich DE, Robinson CH, Fletcher CE, Lowery JC. A systematic exploration of 
differences in contextual factors related to implementing the MOVE! weight management program in VA: a 
mixed methods study. BMC Health Serv Res 2011;11:248. 
10. Dahn JR, Fitzpatrick SL, Llabre MM, et al. Weight management for veterans: examining change in weight 
before and after MOVE! Obesity (Silver Spring) 2011;19:977-81. 
11. Romanova M, Liang LJ, Deng ML, Li Z, Heber D. Effectiveness of the MOVE! Multidisciplinary weight loss 
program for veterans in Los Angeles. Prev Chronic Dis 2013;10:E112. 
12. Kinsinger LS, Kim J. email communication; 2015. 
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