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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
511
The investigators will provide participants with the behavioral lifestyle intervention
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States
Body Weight
Weights were obtained from the VA electronic health record. For the weight variable, baseline is the weight used to identify Veterans for recruitment to participate.
Time frame: Weight closest to 12 months from baseline between 9-15 months post-baseline
Short Form (SF)-12 PCS
The SF-12 is a health-related quality of life measure that assesses general physical (PCS) and mental health (MCS) functioning and well-being, with the PCS score serving as co-primary outcome. The investigators scored the SF-12 using QualityMetric's scoring software. PCS scores range from 0-100 with higher scores indicating better general physical health.
Time frame: 12 months post baseline
International Physical Activity Questionnaire (IPAQ)
7-item short form of the IPAQ, which evaluates weekly walking, vigorous and moderate-intensity activity. The investigators report here the number of participants engaging in at least 150 minutes of activity per week.
Time frame: 12 months post baseline
"Starting the Conversation"
8-item self-report measure of diet quality that assesses intake of various types of food (e.g., fruit and vegetable, sugary beverages). Scores range from 0-16 with higher scores indicating better diet quality.
Time frame: 12 months post baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey Change
4-item self-report scale indicating sleep disturbance. Raw scores are converted into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher scores represent more sleep disturbance.
Time frame: 12 months post baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Survey Change
8-item self-report scale indicating sleep impairment. Raw scores are converted into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher scores represent more sleep impairment.
Time frame: 12 months post baseline
Dietary Self-efficacy
Three items measuring diet self-efficacy from the Patient-centered Assessment and Counseling for Exercise plus Nutrition (PACE+) Adult Psychosocial Questionnaire. Scores range from 1-5 with higher scores representing higher diet self-efficacy.
Time frame: 12 months post baseline
Hemoglobin A1c (HbA1c)
HbA1c values were obtained from the VA electronic health record. HbA1c is a measure of the percentage of glucose in the blood.
Time frame: HbA1c closest to 12 months from baseline between 9-15 months post-baseline
Short Form (SF)-12 Mental Component Score (MCS)
The SF-12 is a health-related quality of life measure that assesses general physical (PCS) and mental health (MCS) functioning and well-being, with the MCS score assessing mental health status. The investigators scored the SF-12 using QualityMetric's scoring software. MCS scores range from 0-100 with higher scores indicating better general menal health.
Time frame: 12 months post baseline
Diastolic Blood Pressure (DBP)
DBP values were obtained from the VA electronic health record. DBP is a measure of artery pressure when the heart rests between beats.
Time frame: DBP closest to 12 months from baseline between 9-15 months post-baseline
Systolic Blood Pressure (SBP)
SBP values were obtained from the VA electronic health record. SBP is a measure of how much pressure blood is exerting against artery walls when the heart beats.
Time frame: SBP closest to 12 months from baseline between 9-15 months post-baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.