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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT02085785
First received: January 17, 2014
Last updated: March 25, 2014
Last verified: March 2014
  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. We 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 Department of Veterans Affairs:

Primary Outcome Measures:
  • Feasibility (recruitment) [ Time Frame: During recruitment (expected duration of 12-15 months) ] [ Designated as safety issue: No ]
    Specific components include yield by method, recruitment rate, refusal rates and reasons, eligibility criteria (sufficient or too restrictive), staff time to compile mailings, respond to phone calls, etc.


Secondary Outcome Measures:
  • Feasibility (adherence) [ Time Frame: Baseline and follow-up assessments (all participants) and during intervention (intervention group only) (weekly, for 20 weeks) ] [ Designated as safety issue: No ]
    Specific components include % of randomized individuals who complete baseline and study exit visit (both groups), % of phone calls completed (intervention group), % goals completed (intervention group), completion of eating and activity logs (intervention group), amount of missing data on questionnaires (both groups), pedometer wear time (both groups)

  • Fidelity and acceptability [ Time Frame: During intervention (weekly for 20 weeks, intervention group only) and at follow-up assessment (20-weeks follow-up) ] [ Designated as safety issue: Yes ]
    Fidelity will be assessed during coaching calls via fidelity checklists including key concepts covered, duration of phone sessions, audiotape review of calls. Acceptability of intervention will be assessed via a brief satisfaction survey and qualitative interviews. Acceptability in terms of safety will be assessed by the number of injuries and adverse events compared to expected rates.

  • Secondary measures related to program effectiveness, including weight change, physical functioning, etc. [ Time Frame: Baseline and follow-up assessments (20-weeks, 12-months, and 18-months after randomization) ] [ Designated as safety issue: No ]
    Measures include weight, waist circumference, body composition (as measured by DEXA), diet (via a focused dietary recall), physical activity (via objective physical activity monitors and self-report measures), and physical functioning (e.g., 6-minute walk, get up and go, and self-report measures)

  • Physical functioning [ Time Frame: Baseline and at follow-up assessments (20-weeks, 12-months, and 18-months after randomization) ] [ Designated as safety issue: No ]
    Physical functioning will be measured via a 2- and 6-minute walk, get up and go, and self-report measures

  • Diet and physical activity [ Time Frame: Baseline and follow-up assessments (20-weeks, 12-months, and 18-months after randomization) ] [ Designated as safety issue: No ]
    Diet will be measured via focused 24-hour dietary recalls. Physical activity will be measured via objective physical activity monitors and self-report measures.


Estimated Enrollment: 50
Study Start Date: February 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: May 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 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.

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 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
Genders Eligible for Study:   Both
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

Contacts
Contact: Barbara Majerczyk, MPH BA (206) 277-5127 Barbara.Majerczyk@va.gov
Contact: Alyson J Littman, PhD MPH (206) 277-4162 alyson.littman@va.gov

Locations
United States, Washington
VA Puget Sound Health Care System, Seattle Recruiting
Seattle, Washington, United States, 98108
Contact: Barbara Majerczyk, MPH BA    206-277-5127    Barbara.Majerczyk@va.gov   
Principal Investigator: Alyson J. Littman, PhD MPH         
Sponsors and Collaborators
Investigators
Principal Investigator: Alyson J. Littman, PhD MPH VA Puget Sound Health Care System, Seattle
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT02085785     History of Changes
Other Study ID Numbers: F6982-Wa
Study First Received: January 17, 2014
Last Updated: March 25, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
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 August 21, 2014