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Weight Loss Intervention for Individuals With Lower Extremity Amputation (MOVE-LEAP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02085785
First received: January 17, 2014
Last updated: January 10, 2017
Last verified: January 2017
  Purpose

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.

Condition Intervention
Lower Extremity Amputation Behavioral: Coached group Behavioral: Self-directed control group Other: Screened only

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Home-based Weight Loss Intervention for Individuals With Lower Extremity Amputation

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Number of Individuals That Were Randomized of Those Contacted (Feasibility) [ Time Frame: During recruitment (expected duration of 12-15 months) ]
    Specific components include yield by method, recruitment rate, refusal rates and reasons


Secondary Outcome Measures:
  • Feasibility - Retention [ Time Frame: 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 [ Time Frame: 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 Weight [ Time Frame: Baseline and follow-up assessment (20-weeks after randomization) ]
    Changes between baseline and 20-weeks later (end of intervention)

  • Change in 6-minute Walk Distance [ Time Frame: Baseline and at follow-up assessment (20-weeks after randomization) ]
    Change in 6-minute walk distance (ft) from baseline to follow-up


Enrollment: 15
Study Start Date: February 2014
Estimated Study Completion Date: June 2018
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Coached
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
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
Active Comparator: Self-directed
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
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.
Screened
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
Screened only - No intervention -- individuals who are contacted and/or screened for eligibility

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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02085785

Locations
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Alyson J. Littman, PhD MPH VA Puget Sound Health Care System Seattle Division, Seattle, WA
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02085785     History of Changes
Other Study ID Numbers: F6982-Wa
Study First Received: January 17, 2014
Results First Received: November 10, 2016
Last Updated: January 10, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by VA Office of Research and Development:
weight loss
exercise
home-based
lower extremity amputation
pilot study

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 23, 2017