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NCT02085785 · ClinicalTrials.gov registry record · NA
Weight Loss Intervention for Individuals With Lower Extremity Amputation
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT02085785: Completed NA study, sponsored by VA Office of Research and Development.
NCT02085785 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02085785, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
The purpose of this study is to pilot test a program to help overweight and obese individuals with a lower extremity amputation (LEA) lose weight and become more physically active. The investigators will randomize approximately 30 individuals to either a self-directed weight loss program (n=15) or a coached weight loss program (n=15). The primary purpose of this pilot study is to determine if a home-based weight loss/physical activity (PA) intervention is feasible in individuals with a LEA. MOVE-LEAP is a 20-week program that involves 11 phone calls from a health coach and a single home visit by a physical therapist. This pilot study aims to: 1. test the feasibility of recruiting overweight/obese individuals with LEA into a randomized trial; 2. assess whether the intervention can be delivered with high fidelity, and 3. evaluate whether the intervention is acceptable to and safe as determined by participant feedback, participation and retention for outcome measures.
Interventions
- BEHAVIORAL Coached group
- BEHAVIORAL Self-directed control group
- OTHER Screened only
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-02-20 |
| Est. Completion | 2018-05-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02085785
The ClinicalTrials.gov registry entry for NCT02085785 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 15 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 3 interventions - of which Coached group is the first listed.
NCT02085785 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02085785 about?
NCT02085785 is a clinical study titled "Weight Loss Intervention for Individuals With Lower Extremity Amputation". The purpose of this study is to pilot test a program to help overweight and obese individuals with a lower extremity amputation (LEA) lose weight and become more physically active. The investigators will randomize approximately 30 individuals to either a self-directed weight loss program (n=15) or a...
What is the current status of trial NCT02085785?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2014-02-20. Estimated completion is 2018-05-01.
What interventions are being tested in trial NCT02085785?
The interventions under investigation include: Coached group (BEHAVIORAL), Self-directed control group (BEHAVIORAL), Screened only (OTHER).
Who is sponsoring clinical trial NCT02085785?
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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