Weight Loss Intervention for Individuals With Lower Extremity Amputation (MOVE-LEAP)
Lower Extremity Amputation
About this trial
This is an interventional treatment trial for Lower Extremity Amputation focused on measuring weight loss, exercise, home-based, lower extremity amputation, pilot study
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
Sites / Locations
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Other
Coached
Self-directed
Screened
Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.
Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.
Individuals who were contacted to inform them about the study or who contacted study personnel to express an interest in participating. This group is presented in order to present statistics on feasibility regarding recruitment