Weight Loss Intervention for Individuals With Lower Extremity Amputation

Completed · Not applicable

Conditions studied: Lower Extremity Amputation

In brief

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.

Key facts

Study ID

NCT02085785

Run by

VA Office of Research and Development

People needed

15

Starts

2014-02-20

Expected to finish

2018-05-01

Last updated by the study team

2018-06-29

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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