Clinical trial NCT03260140: DVD Lifestyle Intervention
Official title: DVD Lifestyle Intervention (D-ELITE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: weight loss
lifestyle
diet
exercise
randomized controlled trial
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-08-24
Enrollment: 511
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will randomly assign participants to one of two groups.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Recent VA primary care measured BMI between 30.0-44.9 kg/m2 (at facility in pacific or mountain time zone)
* Access to DVD player or internet
* Able to participate fully in all study protocol/procedures including informed consent

Exclusion Criteria:

* Inability to speak, read, or understand English
* 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)
* 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
* Pregnant, lactating, or planning to become pregnant during the study period;
* Participation in other intervention studies

Primary outcomes:
measure: Body Weight
timeFrame: Weight closest to 12 months from baseline between 9-15 months post-baseline
measure: Short Form (SF)-12 PCS
timeFrame: 12 months post baseline
Secondary outcomes:
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: 12 months post baseline
measure: "Starting the Conversation"
timeFrame: 12 months post baseline
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey Change
timeFrame: 12 months post baseline
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Survey Change
timeFrame: 12 months post baseline
measure: Dietary Self-efficacy
timeFrame: 12 months post baseline
measure: Hemoglobin A1c (HbA1c)
timeFrame: HbA1c closest to 12 months from baseline between 9-15 months post-baseline
measure: Short Form (SF)-12 Mental Component Score (MCS)
timeFrame: 12 months post baseline
measure: Diastolic Blood Pressure (DBP)
timeFrame: DBP closest to 12 months from baseline between 9-15 months post-baseline
measure: Systolic Blood Pressure (SBP)
timeFrame: SBP closest to 12 months from baseline between 9-15 months post-baseline
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Katherine D Hoerster, PhD MPH BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoerster KD, Collins MP, Au DH, Lane A, Epler E, McDowell J, Baron AE, Rise P, Plumley R, Nguyen T, Schooler M, Schuttner L, Ma J. Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial. Contemp Clin Trials. 2020 Aug;95:106045. doi: 10.1016/j.cct.2020.106045. Epub 2020 May 28.