DVD Lifestyle Intervention

NCT03260140 | Completed Results DMC

• 2 other identifiers: IIR 15-364I01HX002113
• Study Type: interventional
• Target: 511
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 months post baseline

Secondary Outcomes (9)

• International Physical Activity Questionnaire (IPAQ)

  12 months post baseline

• "Starting the Conversation"

  12 months post baseline

• Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey Change

  12 months post baseline

• Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Survey Change

  12 months post baseline

• Dietary Self-efficacy

  12 months post baseline

Study Arms (2)

behavioral lifestyle intervention

EXPERIMENTAL

The investigators will provide participants with the the behavioral lifestyle intervention

Behavioral: behavioral lifestyle intervention

usual care control

NO INTERVENTION

participant in this arm will continue with usual care

Interventions

behavioral lifestyle intervention BEHAVIORAL

The investigators will provide participants with the behavioral lifestyle intervention

behavioral lifestyle intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

Location

Related Publications (2)

• 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.

  PMID: 32473403 RESULT

• Hoerster KD, Hunter-Merrill R, Nguyen T, Rise P, Baron AE, McDowell J, Donovan LM, Gleason E, Lane A, Plumley R, Schooler M, Schuttner L, Collins M, Au DH, Ma J. Effect of a Remotely Delivered Self-directed Behavioral Intervention on Body Weight and Physical Health Status Among Adults With Obesity: The D-ELITE Randomized Clinical Trial. JAMA. 2022 Dec 13;328(22):2230-2241. doi: 10.1001/jama.2022.21177.

  PMID: 36511927 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Results Point of Contact

• Title: Margaret P. Collins
• Organization: VA Puget Sound Health Care Sysem

margaret.collins@va.gov

206.764.2085

Study Officials

• Katherine D Hoerster, PhD MPH BA

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The investigators will randomly assign participants to one of two groups.

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: August 24, 2017
• Study Start: February 15, 2018
• Primary Completion: April 1, 2021
• Study Completion: June 30, 2021
• Last Updated: July 28, 2023
• Results First Posted: November 7, 2022

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)