DVD Lifestyle Intervention (D-ELITE)

• ClinicalTrials.gov Identifier: NCT03260140
• Recruitment Status: Completed
• First Posted: August 24, 2017
• Results First Posted: November 7, 2022
• Last Update Posted: November 7, 2022
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

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
Obesity	Behavioral: behavioral lifestyle intervention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 511 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The investigators will randomly assign participants to one of two groups.
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: DVD Lifestyle Intervention (D-ELITE)
• Actual Study Start Date: February 15, 2018
• Actual Primary Completion Date: April 1, 2021
• Actual Study Completion Date: June 30, 2021

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 :

1. Body Weight [ Time Frame: Weight closest to 12 months from baseline between 9-15 months post-baseline ]
   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.
2. Short Form (SF)-12 PCS [ Time Frame: 12 months post baseline ]
   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.

Secondary Outcome Measures :

1. International Physical Activity Questionnaire (IPAQ) [ Time Frame: 12 months post baseline ]
   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.
2. "Starting the Conversation" [ Time Frame: 12 months post baseline ]
   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.
3. Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey Change [ Time Frame: 12 months post baseline ]
   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.
4. Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Survey Change [ Time Frame: 12 months post baseline ]
   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.
5. Dietary Self-efficacy [ Time Frame: 12 months post baseline ]
   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.
6. Hemoglobin A1c (HbA1c) [ Time Frame: HbA1c closest to 12 months from baseline between 9-15 months post-baseline ]
   HbA1c values were obtained from the VA electronic health record. HbA1c is a measure of the percentage of glucose in the blood.
7. Short Form (SF)-12 Mental Component Score (MCS) [ Time Frame: 12 months post baseline ]
   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.
8. Diastolic Blood Pressure (DBP) [ Time Frame: DBP closest to 12 months from baseline between 9-15 months post-baseline ]
   DBP values were obtained from the VA electronic health record. DBP is a measure of artery pressure when the heart rests between beats.
9. Systolic Blood Pressure (SBP) [ Time Frame: SBP closest to 12 months from baseline between 9-15 months post-baseline ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Washington

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)

Documents provided by VA Office of Research and Development:

Study Protocol and Statistical Analysis Plan  [PDF] April 8, 2021

More Information

Publications of Results:

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.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT03260140
• Other Study ID Numbers: IIR 15-364; I01HX002113 ( U.S. NIH Grant/Contract )
• First Posted: August 24, 2017
• Results First Posted: November 7, 2022
• Last Update Posted: November 7, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

weight loss; lifestyle; diet; exercise; randomized controlled trial