Weight Loss Intervention for Individuals With Lower Extremity Amputation

Lower Extremity Amputation Clinical Trial

— MOVE-LEAP  

Official title:

Home-based Weight Loss Intervention for Individuals With Lower Extremity Amputation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02085785
• Other study ID #: F6982-Wa
• Status: Completed
• Phase: N/A
• Start date: February 20, 2014
• Est. completion date: May 1, 2018

Study information

• Verified date: May 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 1, 2018
• Est. primary completion date: November 16, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Lower Extremity Amputation
• Weight Loss

Intervention

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
• 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

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Individuals That Were Randomized of Those Contacted (Feasibility)	Specific components include yield by method, recruitment rate, refusal rates and reasons	During recruitment (expected duration of 12-15 months)
Secondary	Feasibility - Retention	Number of randomized individuals who complete baseline and study exit visit	Follow-up assessments (all participants) and during intervention (intervention group only) (weekly, for 20 weeks)
Secondary	Acceptability	Acceptability of intervention will be assessed via a brief satisfaction survey - % who would recommend the program to a friend	At follow-up assessment (20-weeks follow-up)
Secondary	Change in Weight	Changes between baseline and 20-weeks later (end of intervention)	Baseline and follow-up assessment (20-weeks after randomization)
Secondary	Change in 6-minute Walk Distance	Change in 6-minute walk distance (ft) from baseline to follow-up	Baseline and at follow-up assessment (20-weeks after randomization)