Trial Outcomes & Findings for Enhancing Physical Function in the Long-term for Older Adults (NCT NCT04490356)
NCT ID: NCT04490356
Last Updated: 2025-06-26
Results Overview
Proportion retention will be computed by dividing the number of retained subjects at the end of the intervention by the total number of participants
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
12 week endpoint
Results posted on
2025-06-26
Participant Flow
Participant milestones
| Measure |
Legacy Intervention
Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.
Legacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
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|---|---|
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Overall Study
STARTED
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14
|
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Overall Study
COMPLETED
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13
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Legacy Intervention
Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.
Legacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
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|---|---|
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
Enhancing Physical Function in the Long-term for Older Adults
Baseline characteristics by cohort
| Measure |
Legacy Intervention
n=14 Participants
Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.
Legacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
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Age, Categorical
Between 18 and 65 years
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2 Participants
n=99 Participants
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Age, Categorical
>=65 years
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12 Participants
n=99 Participants
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Sex: Female, Male
Female
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9 Participants
n=99 Participants
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Sex: Female, Male
Male
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5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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|
Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
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6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
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8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
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Region of Enrollment
United States
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14 participants
n=99 Participants
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PRIMARY outcome
Timeframe: 12 week endpointPopulation: Participants who completed the study
Proportion retention will be computed by dividing the number of retained subjects at the end of the intervention by the total number of participants
Outcome measures
| Measure |
Legacy Intervention
n=13 Participants
Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.
Legacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
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|---|---|
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Proportion Retention
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93 percent of participants
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PRIMARY outcome
Timeframe: 12 week endpointPopulation: Participants who completed the study; data were not collected for one participant who completed.
Participants will asked to rate their satisfaction by answering the question "Overall, I'm glad I participated in this weight maintenance program" with the following possible responses: 1- strongly disagree , 2- disagree, 3 - neither agree nor disagree, 4- agree, and and 5 -strongly agree. Score ranges from 1- 5 with higher score indicating greater satisfaction
Outcome measures
| Measure |
Legacy Intervention
n=12 Participants
Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.
Legacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
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|---|---|
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Acceptability as Measured by Participant Satisfaction
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4.8 score on a scale
Standard Deviation 0.4
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SECONDARY outcome
Timeframe: 0 weeks, 12 weeksPopulation: Participants who completed the study; data were not collected for one participant who completed.
Scores range from 0 to 12 with higher score indicating better performance.
Outcome measures
| Measure |
Legacy Intervention
n=12 Participants
Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.
Legacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
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|---|---|
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Change in Physical Performance as Measured by the Short Physical Performance Battery
0 weeks (baseline)
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10.6 score on a scale
Standard Deviation 1.2
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Change in Physical Performance as Measured by the Short Physical Performance Battery
12 weeks
|
11.1 score on a scale
Standard Deviation 0.9
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SECONDARY outcome
Timeframe: 0 weeks, 12 weeksPopulation: Due to safety concerns during the COVID pandemic, the 6 Minute Walk Test was not administered to participants at all, so data from the 6 Minute Walk Test were not collected.
Change in distance walked in six minutes from baseline
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 weeks, 12 weeksPopulation: Participants who completed the study; data were not collected for one participant who completed.
Body weight in pounds.
Outcome measures
| Measure |
Legacy Intervention
n=12 Participants
Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.
Legacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
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|---|---|
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Change in Body Weight as Measured by the Aria Fitbit Scale
0 weeks (baseline)
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216.1 pounds
Standard Deviation 29.1
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Change in Body Weight as Measured by the Aria Fitbit Scale
12 weeks
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215.4 pounds
Standard Deviation 27.3
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SECONDARY outcome
Timeframe: 0 weeks, 12 weeksPopulation: Participants who completed the study; data were not collected for one participant who completed.
Average step counts using Garmin watch.
Outcome measures
| Measure |
Legacy Intervention
n=12 Participants
Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.
Legacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
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|---|---|
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Change in Average Weekly Steps Measured Using Garmin Watch
0 weeks (baseline)
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6204.8 steps per week
Standard Deviation 3802.1
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Change in Average Weekly Steps Measured Using Garmin Watch
12 weeks
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6365.0 steps per week
Standard Deviation 4109.8
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SECONDARY outcome
Timeframe: 0 weeks,12 weeksAverage total calories consumed.
Outcome measures
| Measure |
Legacy Intervention
n=11 Participants
Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.
Legacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
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|---|---|
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Change in Total Calories Using 3-day Food Record (Participants Record Everything They Eat and Drink for Three Days)
Baseline
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1418.4 calories
Standard Deviation 364.7
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Change in Total Calories Using 3-day Food Record (Participants Record Everything They Eat and Drink for Three Days)
12 weeks
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1525.8 calories
Standard Deviation 525.3
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SECONDARY outcome
Timeframe: 0 weeks, 12 weeksPopulation: Participants who completed the study
Perceived Stress Scale is a 10-item stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Outcome measures
| Measure |
Legacy Intervention
n=13 Participants
Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.
Legacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
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|---|---|
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Change in Stress Using the Perceived Stress Scale
0 weeks (baseline)
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10.8 score on a scale
Standard Deviation 5.2
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Change in Stress Using the Perceived Stress Scale
12 weeks
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9.0 score on a scale
Standard Deviation 4.3
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SECONDARY outcome
Timeframe: 0 weeks, 12 weeksPopulation: Participants who completed the study
Score ranges from 0-60 with higher scores indicating greater depression symptoms.
Outcome measures
| Measure |
Legacy Intervention
n=13 Participants
Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.
Legacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
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|---|---|
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Change in Self-reported Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D)
week 0 (baseline)
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11.3 score on a scale
Standard Deviation 6.8
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Change in Self-reported Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D)
week 12
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8.8 score on a scale
Standard Deviation 7.0
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SECONDARY outcome
Timeframe: 0 weeks, 12 weeksPopulation: To reduce participant burden during the COVID pandemic, this questionnaire was not administered to participants at all, so data from the Profile of Mood States (POMS) Questionnaire were not collected.
Change in mood from baseline, 6 and 12 weeks. Profile of Mood States is a psychological rating scale used to assess transient, distinct mood states that uses a five-point scale ranging from "not at all" to "extremely".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 weeks, 12 weeksPopulation: Participants who completed the study
Physical functioning scale of the SF-36 is a 10-items scale with a scores ranging from 0-100% where the higher score indicates greater physical functioning.
Outcome measures
| Measure |
Legacy Intervention
n=13 Participants
Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.
Legacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
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|---|---|
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Quality of Life Using the SF-36 Questionnaire - SF-36 Physical Functioning Scale
0 weeks (baseline)
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75.0 scores on a scale
Standard Deviation 18.7
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Quality of Life Using the SF-36 Questionnaire - SF-36 Physical Functioning Scale
12 weeks
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79.2 scores on a scale
Standard Deviation 20.6
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SECONDARY outcome
Timeframe: 0 weeks, 12 weeksPopulation: Participants who completed the study
Role limitations due to physical health scale of the SF-36 is a 4-items scale with a scores ranging from 0-100% where the higher score indicates less limitations due to physical health
Outcome measures
| Measure |
Legacy Intervention
n=13 Participants
Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.
Legacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
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|---|---|
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Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Physical Health Scale
0 weeks (baseline)
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59.6 scores on a scale
Standard Deviation 43.9
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Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Physical Health Scale
12 weeks
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75.0 scores on a scale
Standard Deviation 39.5
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SECONDARY outcome
Timeframe: 0 weeks, 12 weeksPopulation: Participants who completed the study
Role limitations due to emotional problems scale of the SF-36 is a 3-items scale with a scores ranging from 0-100% where the higher score indicates less limitations due to emotional health
Outcome measures
| Measure |
Legacy Intervention
n=13 Participants
Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.
Legacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
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|---|---|
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Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Emotional Problems Scale
0 weeks (baseline)
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66.7 scores on a scale
Standard Deviation 43.0
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Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Emotional Problems Scale
12 weeks
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64.1 scores on a scale
Standard Deviation 46.1
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SECONDARY outcome
Timeframe: 0 weeks, 12 weeksPopulation: Participants who completed the study
Energy/fatigue scale of the SF-36 is a 4-items scale with a scores ranging from 0-100% where the higher score indicates less energy/fatigue
Outcome measures
| Measure |
Legacy Intervention
n=13 Participants
Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.
Legacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
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|---|---|
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Quality of Life Using the SF-36 Questionnaire - Energy/Fatigue Scale
0 weeks (baseline)
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55.4 scores on a scale
Standard Deviation 21.6
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Quality of Life Using the SF-36 Questionnaire - Energy/Fatigue Scale
12 weeks
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58.1 scores on a scale
Standard Deviation 20.5
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SECONDARY outcome
Timeframe: 0 weeks, 12 weeksPopulation: Participants who completed the study
Emotional Well-Being scale of the SF-36 is a 5-items scale with a scores ranging from 0-100% where the higher score indicates greater emotional well-being
Outcome measures
| Measure |
Legacy Intervention
n=13 Participants
Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.
Legacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
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|---|---|
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Quality of Life Using the SF-36 Questionnaire - Emotional Well-Being Scale
0 weeks (baseline)
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78.1 scores on a scale
Standard Deviation 13.6
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Quality of Life Using the SF-36 Questionnaire - Emotional Well-Being Scale
12 weeks
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80.9 scores on a scale
Standard Deviation 10.6
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SECONDARY outcome
Timeframe: 0 weeks, 12 weeksPopulation: Participants who completed the study
Social Functioning scale of the SF-36 is a 2-items scale with a scores ranging from 0-100% where the higher score indicates greater social functioning.
Outcome measures
| Measure |
Legacy Intervention
n=13 Participants
Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.
Legacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
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|---|---|
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Quality of Life Using the SF-36 Questionnaire - Social Functioning Scale
12 weeks
|
83.7 scores on a scale
Standard Deviation 28.1
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Quality of Life Using the SF-36 Questionnaire - Social Functioning Scale
0 weeks (baseline)
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82.7 scores on a scale
Standard Deviation 25.3
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SECONDARY outcome
Timeframe: 0 weeks, 12 weeksPopulation: Participants who completed the study
Pain scale of the SF-36 is a 2-items scale with a scores ranging from 0-100% where the higher score indicates less pain.
Outcome measures
| Measure |
Legacy Intervention
n=13 Participants
Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.
Legacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
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|---|---|
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Quality of Life Using the SF-36 Questionnaire - Pain Scale
0 weeks (baseline)
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68.5 scores on a scale
Standard Deviation 22.9
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Quality of Life Using the SF-36 Questionnaire - Pain Scale
12 weeks
|
75.2 scores on a scale
Standard Deviation 22.4
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SECONDARY outcome
Timeframe: 0 weeks, 12 weeksPopulation: Participants who completed the study
General Health scale of the SF-36 is a 5-items scale with a scores ranging from 0-100% where the higher score indicates greater general health
Outcome measures
| Measure |
Legacy Intervention
n=13 Participants
Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.
Legacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
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|---|---|
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Quality of Life Using the SF-36 Questionnaire - General Health Scale
0 weeks (baseline)
|
64.6 scores on a scale
Standard Deviation 15.5
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Quality of Life Using the SF-36 Questionnaire - General Health Scale
12 weeks
|
63.5 scores on a scale
Standard Deviation 18.0
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Adverse Events
Legacy Intervention
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place