DVD Lifestyle Intervention
NCT03260140 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 511
Last updated 2023-07-28
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.
Conditions
Interventions
- BEHAVIORAL
-
behavioral lifestyle intervention
The investigators will provide participants with the behavioral lifestyle intervention
Sponsors & Collaborators
-
VA Office of Research and Development
lead FED
Principal Investigators
-
Katherine D Hoerster, PhD MPH BA · VA Puget Sound Health Care System Seattle Division, Seattle, WA
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-02-15
- Primary Completion
- 2021-04-01
- Completion
- 2021-06-30
Countries
- United States
Study Locations
More Related Trials
-
Coaching Veterans to Healthy Weights and Wellness
NCT00967668 ·Status: COMPLETED ·Phase: NA
-
Teaching Obesity Treatment Options to Adult Learners Intervention Via VA Video Connect
NCT04878289 ·Status: COMPLETED ·Phase: NA
-
A Randomized Trial of Behaviorally Designed Gamification and Social Incentives to Increase Physical Activity Among Overweight and Obese Veterans
NCT05554601 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Behavioral CVD Prevention Using Informatics
NCT02752464 ·Status: COMPLETED ·Phase: NA
-
The PIVOT Trial: Project on EHR-Integrated Lifestyle Interventions for Adults Aged Fifty and Older
NCT05654142 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Prevention of Obesity in Military Communities - Fit4Duty
NCT02679937 ·Status: COMPLETED ·Phase: NA
-
Telerehabilitation Intervention to Promote Exercise for Diabetes
NCT00334113 ·Status: COMPLETED ·Phase: NA
-
Teaching Obesity Treatment Options to Adult Learners Trial
NCT03856320 ·Status: COMPLETED ·Phase: NA
-
Precision Nutrition Impact on Health-Related Behavior Change
NCT04959318 ·Status: COMPLETED ·Phase: NA
-
MOVE OUT: A Partnership With Veterans Groups to Enhance Weight Management in the Veterans Health Administration (VHA)
NCT01339390 ·Status: COMPLETED ·Phase: NA
-
Translating the Diabetes Prevention Program Into a Virtual Lifestyle Management Program
NCT00867425 ·Status: COMPLETED ·Phase: NA
-
Evaluate Health Coaching Support in Technology-based Interventions for Meeting Health Goals
NCT04021472 ·Status: COMPLETED ·Phase: NA
-
Collaborate2Lose: Involving Support Persons in Weight Management
NCT05448313 ·Status: COMPLETED ·Phase: NA
-
Modifying Adiposity Through Behavioral Strategies to Improve COVID-19 Rehabilitation
NCT05880108 ·Status: RECRUITING ·Phase: NA
-
Healthy Lifestyle Program: A Novel Group-based Training
NCT05083962 ·Status: UNKNOWN ·Phase: NA
-
HealthyTogether: RCT of a Dyadic Weight Management Intervention
NCT06619041 ·Status: RECRUITING ·Phase: NA
-
Feedback of Treatment Intensification Data to Reduce Cardiovascular Disease Risk (FIT)
NCT00517686 ·Status: COMPLETED ·Phase: NA
-
A Study of a Values-Based Intervention to Promote Weight Loss
NCT03991676 ·Status: COMPLETED ·Phase: NA
-
TOTAL: A Multisite RCT
NCT05346575 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
An Observational Cohort Study to Obese Patients With Weight Cycling
NCT05311462 ·Status: ACTIVE_NOT_RECRUITING
-
Veterans Walk for Health Study
NCT00123435 ·Status: COMPLETED ·Phase: NA
-
Creating an Optimized Technology-Based Weight Loss Program for Cardiac Rehabilitation Patients
NCT03845283 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Preventing Obesity in Military Communities-Adolescents
NCT02671292 ·Status: UNKNOWN ·Phase: NA
-
Web-based Weight Loss Intervention
NCT03400696 ·Status: COMPLETED ·Phase: NA
-
The Effects of a Mobile Health Intervention and Health Coach Text Messaging on Cardiovascular Risk of Older Adults
NCT03720327 ·Status: COMPLETED ·Phase: NA