Weight Loss Intervention for Individuals With Lower Extremity Amputation

NCT02085785 | Completed Results

• 1 other identifier: F6982-Wa
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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. 1.test the feasibility of recruiting overweight/obese individuals with LEA into a randomized trial;
2. 2.assess whether the intervention can be delivered with high fidelity, and
3. 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

Keywords

weight loss; exercise; home-based; lower extremity amputation; pilot study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Feasibility - Retention

  Follow-up assessments (all participants) and during intervention (intervention group only) (weekly, for 20 weeks)

• Acceptability

  At follow-up assessment (20-weeks follow-up)

• Change in Weight

  Baseline and follow-up assessment (20-weeks after randomization)

• Change in 6-minute Walk Distance

  Baseline and at follow-up assessment (20-weeks after randomization)

Study Arms (3)

Coached

EXPERIMENTAL

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.

Behavioral: Coached group

Self-directed

ACTIVE COMPARATOR

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.

Behavioral: Self-directed control group

Screened

OTHER

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

Other: Screened only

Interventions

Coached group BEHAVIORAL

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

Coached

Self-directed control group BEHAVIORAL

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.

Self-directed

Screened only OTHER

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

Screened

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

Related Publications (1)

• Littman AJ, Haselkorn JK, Arterburn DE, Boyko EJ. Pilot randomized trial of a telephone-delivered physical activity and weight management intervention for individuals with lower extremity amputation. Disabil Health J. 2019 Jan;12(1):43-50. doi: 10.1016/j.dhjo.2018.08.002. Epub 2018 Aug 10.

  PMID: 30115584 DERIVED

MeSH Terms

Conditions

Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Dr. Alyson Littman, Research Health Scientist
• Organization: Department of Veterans Affairs

alyson.littman@va.gov

206-277-4182

Study Officials

• Alyson J. Littman, PhD MPH

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: March 13, 2014
• Study Start: February 20, 2014
• Primary Completion: November 16, 2015
• Study Completion: May 1, 2018
• Last Updated: June 29, 2018
• Results First Posted: March 3, 2017

Record last verified: 2018-05

Locations

US (1)