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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:
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.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Retention | Number of randomized individuals who complete baseline and study exit visit | Follow-up assessments (all participants) and during intervention (intervention group only) (weekly, for 20 weeks) |
| Acceptability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alyson J. Littman, PhD MPH | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30115584 | Derived | 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. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Individuals who completed all baseline procedures including consent are included. Those who consented to participate but did not complete all baseline procedures are not included as baseline participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Individuals That Were Randomized of Those Contacted (Feasibility) | Specific components include yield by method, recruitment rate, refusal rates and reasons | 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. | Posted | Number | participants | During recruitment (expected duration of 12-15 months) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alyson Littman, Research Health Scientist | Department of Veterans Affairs | 206-277-4182 | alyson.littman@va.gov |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 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. |
|
| Screened only | Other | Screened only - No intervention -- individuals who are contacted and/or screened for eligibility |
|
Acceptability of intervention will be assessed via a brief satisfaction survey - % who would recommend the program to a friend
| At follow-up assessment (20-weeks follow-up) |
| Change in Weight | Changes between baseline and 20-weeks later (end of intervention) | Baseline and follow-up assessment (20-weeks after randomization) |
| Change in 6-minute Walk Distance | Change in 6-minute walk distance (ft) from baseline to follow-up | Baseline and at follow-up assessment (20-weeks after randomization) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Participants |
|
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| Secondary | Feasibility - Retention | Number of randomized individuals who complete baseline and study exit visit | Posted | Number | participants | Follow-up assessments (all participants) and during intervention (intervention group only) (weekly, for 20 weeks) |
|
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| Secondary | Acceptability | Acceptability of intervention will be assessed via a brief satisfaction survey - % who would recommend the program to a friend | 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. | Posted | Count of Participants | Participants | At follow-up assessment (20-weeks follow-up) |
|
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| Secondary | Change in Weight | Changes between baseline and 20-weeks later (end of intervention) | Those who were not assessed at 20 weeks were assumed to have the same values as at baseline (last observation carried forward) | Posted | Mean | 95% Confidence Interval | pounds | Baseline and follow-up assessment (20-weeks after randomization) |
|
|
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| Secondary | Change in 6-minute Walk Distance | Change in 6-minute walk distance (ft) from baseline to follow-up | Baseline carried forward if 20-week follow-up data not collected | Posted | Mean | 95% Confidence Interval | feet | Baseline and at follow-up assessment (20-weeks after randomization) |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | 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. | 0 | 8 | 0 | 8 |
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| D001519 | Behavior |