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Weight Loss Intervention for Individuals With Lower Extremity Amputation

NCT02085785 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-06-29

Study results available
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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.

Conditions

  • Lower Extremity Amputation

Interventions

BEHAVIORAL

Coached group

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

BEHAVIORAL

Self-directed control group

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.

OTHER

Screened only

Screened only - No intervention -- individuals who are contacted and/or screened for eligibility

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Alyson J. Littman, PhD MPH · VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-20
Primary Completion
2015-11-16
Completion
2018-05-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02085785 on ClinicalTrials.gov