Lower Extremity Amputation
Conditions
Keywords
weight loss, exercise, home-based, lower extremity amputation, pilot study
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. 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.
Interventions
BEHAVIORALCoached 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
BEHAVIORALSelf-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.
OTHERScreened only
Screened only - No intervention -- individuals who are contacted and/or screened for eligibility
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Individuals That Were Randomized of Those Contacted (Feasibility) | During recruitment (expected duration of 12-15 months) | Specific components include yield by method, recruitment rate, refusal rates and reasons |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Retention | 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 | 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 | 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 | Baseline and at follow-up assessment (20-weeks after randomization) | Change in 6-minute walk distance (ft) from baseline to follow-up |
Countries
United States
Participant flow
Pre-assignment details
303 participants were contacted to recruit them into the study \[VHA patient (n=237) and UWMC or Harborview patient (n=56)\] and 10 individuals contacted study personnel expressing an interest in participating (n=313) 15 participants were consented and enrolled, but 313 individuals will be assessed for the purpose of assessing feasibility
Participants by arm
| Arm | Count |
|---|---|
| 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.
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 | 7 |
| 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.
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. | 8 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Coached | Self-directed | Total |
|---|---|---|---|
| Age, Continuous | 56.0 years STANDARD_DEVIATION 10.6 | 56.6 years STANDARD_DEVIATION 10.7 | 56.3 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment United States | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 8 |
| serious Total, serious adverse events | 0 / 7 | 0 / 8 |
Outcome results
Primary
Number of Individuals That Were Randomized of Those Contacted (Feasibility)
Specific components include yield by method, recruitment rate, refusal rates and reasons
Time frame: During recruitment (expected duration of 12-15 months)
Population: 313 individuals were assessed for this outcome measure. Note that the number analyzed are those that we contacted via a mailing or who contacted the study after seeing a study flyer.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study Feasibility | Number of Individuals That Were Randomized of Those Contacted (Feasibility) | 15 participants |
Secondary
Acceptability
Acceptability of intervention will be assessed via a brief satisfaction survey - % who would recommend the program to a friend
Time frame: At follow-up assessment (20-weeks follow-up)
Population: Number who reported that they would recommend the program to a friend. Intervention assessment questionnaires were not linked to other study data, so we are unable to report study group information. The number analyzed are those who completed the 20-week follow-up measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Study Feasibility | Acceptability | 8 Participants |
Secondary
Change in 6-minute Walk Distance
Change in 6-minute walk distance (ft) from baseline to follow-up
Time frame: Baseline and at follow-up assessment (20-weeks after randomization)
Population: Baseline carried forward if 20-week follow-up data not collected
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Overall Study Feasibility | Change in 6-minute Walk Distance | 185.4 feet |
| Self-directed | Change in 6-minute Walk Distance | 43.2 feet |
Secondary
Change in Weight
Changes between baseline and 20-weeks later (end of intervention)
Time frame: Baseline and follow-up assessment (20-weeks after randomization)
Population: Those who were not assessed at 20 weeks were assumed to have the same values as at baseline (last observation carried forward)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Overall Study Feasibility | Change in Weight | -7.3 pounds |
| Self-directed | Change in Weight | 1.3 pounds |
Secondary
Feasibility - Retention
Number of randomized individuals who complete baseline and study exit visit
Time frame: Follow-up assessments (all participants) and during intervention (intervention group only) (weekly, for 20 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study Feasibility | Feasibility - Retention | 5 participants |
| Self-directed | Feasibility - Retention | 6 participants |