Weight Loss Intervention for Individuals With Lower Extremity Amputation

Not Applicable

Completed

• Conditions: Lower Extremity Amputation
• Interventions: Behavioral: Coached group; Behavioral: Self-directed control group; Other: Screened only

• Registration Number: NCT02085785
• Lead Sponsor: VA Office of Research and Development

Brief 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.

Detailed Description

Participants randomized to the intervention arm will receive (1) a home visit by an exercise specialist and (2) a 20-week telephone-delivered weight loss program, modeled on the VA's Telephone Lifestyle Coaching Program (MOVE!TLC). All participants (both the coached arm and self-directed arm) will be mailed a MOVE-LEAP packet \[containing eating and physical activity logs, information on how to set weight loss goals, suggestions for physical activity/exercise, dietary guides, etc.), a MOVE-LEAP handout booklet, calories counting book, a pedometer, exercise digital versatile disc (DVD), and a flip-booklet with exercises ("Exercise Guide for Persons with Limb Loss"). A bathroom scale will be provided for participants who do not already own one.

Participants in the coached arm will receive a home visit by an exercise specialist. This visit will occur 1-3 weeks after randomization. The exercise specialist will assess the participant's capabilities and interest regarding physical activity as well as his/her home environment for physical activity. Since each participant may have different physical capabilities and limitations, the type and intensity of physical activity will be tailored to each participant's preferences and their home and neighborhood/community environment and resources. If the participant is interested in performing physical activity outside their home, study staff will provide them with information about community resources for physical activities.

Participants in the coached arm will receive 11 calls by a study health coach. During the phone calls (weekly initially and then every other week), the health coach will review progress and help the participant to set "SMART" goals (Specific, Measurable, Attainable, Relevant and Time-limited) and will use motivational interviewing techniques to help the participant achieve those goals. Motivational interviewing is a style of counseling meant to increase participant engagement through strategic use of open-ended questions, reflective listening and positive affirmations. The study staff will review the participant's progress on his or her goals and help him or her problem solve to resolve challenges and modify goals as needed. During each session, the coach will discuss an educational topic relating to weight loss. Written materials on each topic are included the booklet.

Study Timeline

• Study First Submitted: 2014-01-17
• Study Start: 2014-02-20
• Study First Submitted QC: 2014-03-10
• Study First Posted: 2014-03-13
• Primary Completion: 2015-11-16
• Results First Submitted: 2016-11-10
• Results First Submitted QC: 2017-01-10
• Results First Posted: 2017-03-03
• Status Verified: 2018-05
• Study Completion: 2018-05-01
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coached	Coached group	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.
Self-directed	Self-directed control group	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.
Screened	Screened only	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

Primary Outcome Measures

Name	Time	Method
Number of Individuals That Were Randomized of Those Contacted (Feasibility)	During recruitment (expected duration of 12-15 months)	Specific components include yield by method, recruitment rate, refusal rates and reasons

Secondary Outcome Measures

Name	Time	Method
Feasibility - Retention	Follow-up assessments (all participants) and during intervention (intervention group only) (weekly, for 20 weeks)	Number of randomized individuals who complete baseline and study exit visit
Acceptability	At follow-up assessment (20-weeks follow-up)	Acceptability of intervention will be assessed via a brief satisfaction survey - % who would recommend the program to a friend
Change in 6-minute Walk Distance	Baseline and at follow-up assessment (20-weeks after randomization)	Change in 6-minute walk distance (ft) from baseline to follow-up
Change in Weight	Baseline and follow-up assessment (20-weeks after randomization)	Changes between baseline and 20-weeks later (end of intervention)

Trial Locations

Locations (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA; 🇺🇸 Seattle, Washington, United States