Weight Loss Intervention for Individuals With Lower Extremity Amputation
Condition: Lower Extremity Amputation
MeSH terms: Weight Loss
Study type: Interventional

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.
    

Intervention name(s): Coached group; Self-directed control group; Screened only
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): 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; 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 only - No intervention -- individuals who are contacted and/or screened for eligibility
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: weight loss; exercise; home-based; lower extremity amputation; pilot study