D-ELITE: DVD Lifestyle Intervention
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: behavioral lifestyle intervention The investigators will provide participants with the the behavioral lifestyle intervention |
Behavioral: behavioral lifestyle intervention
The investigators will provide participants with the behavioral lifestyle intervention
|
| No Intervention: usual care control participant in this arm will continue with usual care |
Outcome Measures
Primary Outcome Measures
- body weight drawn from VA medical record [all weights from 9 to 15 months post baseline]
The investigators will compare weights between intervention and control
- SF-12 PCS [12 months post baseline]
The investigators will compare general health status between intervention and control using the SF-12 PCS.
Secondary Outcome Measures
- International Physical Activity Questionnaire (IPAQ) [12 and 24 months post baseline]
The investigators will compare physical activity between intervention and control using the International Physical Activity Questionnaire (IPAQ).
- "Starting the Conversation" [12 and 24 months post baseline]
The investigators will compare dietary quality between intervention and control using the "Starting the Conversation" questionnaire.
- PROMIS - Sleep Disturbance Survey change [12 and 24 months post baseline]
The investigators will compare sleep-related disturbance between intervention and control using the PROMIS - Sleep Disturbance Survey.
- PROMIS - Sleep Related Impairment Survey change [12 and 24 months post baseline]
The investigators will compare sleep-related impairment between intervention and control using the PROMIS - Sleep Related Impairment Survey.
- modified "PACE+ dietary self-efficacy" change [12 and 24 months post baseline]
The investigators will compare dietary self-efficacy between intervention and control using questions modified from the PACE Adult Psychosocial Questionnaire.
- biometrics drawn from VA medical record [baseline through 27 months post baseline]
The investigators will compare blood pressure and Hb1Ac levels between intervention and control.
- SF-12 [12 and 24 months post baseline]
The investigators will compare general health status (PCS and MCS) between intervention and control using the SF-12.
- body weight drawn from VA medical record [15-27 months post baseline]
The investigators will compare body weight between intervention and control.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Recent VA primary care measured BMI between 30.0-44.9 kg/m2 (at facility in pacific or mountain time zone)
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Access to DVD player or internet
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Able to participate fully in all study protocol/procedures including informed consent
Exclusion Criteria:
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Inability to speak, read, or understand English
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Recent weight loss interventions including use of prescription weight-loss medications, participation in group or individual weight loss programs provided by trained personnel, bariatric surgery (or plans for during the study period)
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Expected weight loss because of alternate explanations such as from illness
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High variability in weight due to fluctuations in volume status (ascites - liver disease, chronic heart failure)
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Safety and/or adherence concerns due to severe physical or mental health issues, or life expectancy <24 months
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Pregnant, lactating, or planning to become pregnant during the study period;
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Participation in other intervention studies
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | United States | 98108 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Katherine D Hoerster, PhD MPH BA, VA Puget Sound Health Care System Seattle Division, Seattle, WA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IIR 15-364
- I01HX002113