N/A
Completed N=15
Weight Loss Intervention for Individuals With Lower Extremity Amputation
Lower Extremity Amputation
Source: ClinicalTrials.gov NCT02085785 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Number of Individuals That Were Randomized of Those Contacted (Feasibility) — 15 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Individuals That Were Randomized of Those Contacted (Feasibility) |
15 | — |
| SECONDARY Feasibility - Retention |
5; 6 | — |
| SECONDARY Acceptability |
8 | — |
| SECONDARY Change in Weight |
-7.3; 1.3 | — |
| SECONDARY Change in 6-minute Walk Distance |
185.4; 43.2 | — |
Eligibility Criteria
Inclusion Criteria
- Lower extremity amputation (including toes) for at least 1 year
- overweight or obese
- <60 minutes drive-time to VA Puget Sound Health Care System - Seattle campus, willing to be randomized
- provides written, informed consent
- able to perform some form of aerobic exercise (e.g., walking, bicycling, swimming)
- has telephone
- able to complete study assessments
Exclusion Criteria
- Co-morbidities which may be contraindicated or indicate no potential benefit from weight loss or increasing physical activity
- unlikely to be able to adhere to study protocol and complete questionnaires and measurements reliably
- recent or current (last 6 months) participation in a weight loss program, including taking weight loss medications
- only uses motorized (non-manual) wheelchair
Data sourced from ClinicalTrials.gov (NCT02085785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.