N/A N=15 Randomized Single-blind Treatment

Weight Loss Intervention for Individuals With Lower Extremity Amputation

Lower Extremity Amputation

Bottom Line

View on ClinicalTrials.gov: NCT02085785 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcome: Primary: Number of Individuals That Were Randomized of Those Contacted (Feasibility) — 15 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Coached group (Behavioral); Self-directed control group (Behavioral); Screened only (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Nov 2015

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	—

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.

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

View full record on ClinicalTrials.gov →

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.