At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Home-based Weight Loss Intervention for Individuals With Lower Extremity Amputation
In Brief
A clinical study evaluating Coached group, Self-directed control group, and 1 other intervention for Lower Extremity Amputation. Completed, enrolled 15 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Participants randomized to the coached arm will receive 1) education and self-monitoring materials \[e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)\], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur
Participants randomized to the self-directed control arm will receive the same educational and self-monitoring materials as the coached group \[e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)\], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.
Screened only - No intervention -- individuals who are contacted and/or screened for eligibility