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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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). 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.
Primary Outcome
Specific components include yield by method, recruitment rate, refusal rates and reasons
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 |
What the finished NCT02085785 record still lists
NCT02085785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Coached group is the first listed.
NCT02085785 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02085785's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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