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NCT03260140 · ClinicalTrials.gov registry record · NA
DVD Lifestyle Intervention
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 511
- Enrollment target
NCT03260140: Completed NA study, sponsored by VA Office of Research and Development.
NCT03260140 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 511 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03260140, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 511 participants
- Enrollment target
Study 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-u
Interventions
- BEHAVIORAL behavioral lifestyle intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 511 participants |
| Start Date | 2018-02-15 |
| Est. Completion | 2021-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03260140
The ClinicalTrials.gov registry entry for NCT03260140 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 511 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which behavioral lifestyle intervention is the first listed.
NCT03260140 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03260140 about?
NCT03260140 is a clinical study titled "DVD Lifestyle Intervention". 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 Cent...
What is the current status of trial NCT03260140?
This trial is currently completed. It is a NA study. The enrollment target is 511 participants. The study started on 2018-02-15. Estimated completion is 2021-06-30.
What interventions are being tested in trial NCT03260140?
The interventions under investigation include: behavioral lifestyle intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03260140?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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