Trial Outcomes & Findings for Weight Loss Intervention for Individuals With Lower Extremity Amputation (NCT NCT02085785)
NCT ID: NCT02085785
Last Updated: 2018-06-29
Results Overview
Specific components include yield by method, recruitment rate, refusal rates and reasons
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
During recruitment (expected duration of 12-15 months)
Results posted on
2018-06-29
Participant Flow
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
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Weight Loss Intervention for Individuals With Lower Extremity Amputation
Baseline characteristics by cohort
| Measure |
Coached
n=7 Participants
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
|
Self-directed
n=8 Participants
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.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.0 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
56.6 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
56.3 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Specific components include yield by method, recruitment rate, refusal rates and reasons
Outcome measures
| Measure |
Overall Study Feasibility
n=313 Participants
Reporting of recruitment and eligibility for the targeted population
|
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.
|
|---|---|---|
|
Number of Individuals That Were Randomized of Those Contacted (Feasibility)
|
15 participants
|
—
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Overall Study Feasibility
n=7 Participants
Reporting of recruitment and eligibility for the targeted population
|
Self-directed
n=8 Participants
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.
|
|---|---|---|
|
Feasibility - Retention
|
5 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 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.
Acceptability of intervention will be assessed via a brief satisfaction survey - % who would recommend the program to a friend
Outcome measures
| Measure |
Overall Study Feasibility
n=9 Participants
Reporting of recruitment and eligibility for the targeted population
|
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.
|
|---|---|---|
|
Acceptability
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: 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)
Changes between baseline and 20-weeks later (end of intervention)
Outcome measures
| Measure |
Overall Study Feasibility
n=7 Participants
Reporting of recruitment and eligibility for the targeted population
|
Self-directed
n=8 Participants
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.
|
|---|---|---|
|
Change in Weight
|
-7.3 pounds
Interval -16.0 to 1.5
|
1.3 pounds
Interval -2.8 to 5.3
|
SECONDARY outcome
Timeframe: Baseline and at follow-up assessment (20-weeks after randomization)Population: Baseline carried forward if 20-week follow-up data not collected
Change in 6-minute walk distance (ft) from baseline to follow-up
Outcome measures
| Measure |
Overall Study Feasibility
n=7 Participants
Reporting of recruitment and eligibility for the targeted population
|
Self-directed
n=8 Participants
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.
|
|---|---|---|
|
Change in 6-minute Walk Distance
|
185.4 feet
Interval -31.9 to 402.8
|
43.2 feet
Interval -69.1 to 155.4
|
Adverse Events
Coached
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Self-directed
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Alyson Littman, Research Health Scientist
Department of Veterans Affairs
Phone: 206-277-4182
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place