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| ID | Type | Description | Link |
|---|---|---|---|
| 1P30AG064201-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The intervention being studied is a 12-week nutrition and physical activity intervention, delivered using videoconference technology by registered dietitian clinicians to maintain weight loss and functional gains in older adults who successfully completed a weight loss intervention. The "Legacy Intervention" will include cognitive behavioral strategies (e.g., goal setting, self-monitoring, and social support), and draw upon a toolbox of e-approaches, including daily and weekly text reminders, virtual exercise classes, virtual individual and group nutrition classes, and step tracking device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Legacy Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Legacy Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion Retention | Proportion retention will be computed by dividing the number of retained subjects at the end of the intervention by the total number of participants | 12 week endpoint |
| Acceptability as Measured by Participant Satisfaction | 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 | 12 week endpoint |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Performance as Measured by the Short Physical Performance Battery | Scores range from 0 to 12 with higher score indicating better performance. | 0 weeks, 12 weeks |
| Change in Physical Function as Measured Using the 6 Minute Walk Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Starr, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University, School of Medicine | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Proportion Retention | Proportion retention will be computed by dividing the number of retained subjects at the end of the intervention by the total number of participants | Participants who completed the study | Posted | Number | percent of participants | 12 week endpoint |
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12 weeks
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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 | 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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Due to COVID restrictions, the research team had to minimize the number of in-person visits. Consequently, outcome measures data was only collected for baseline (0 weeks) and at 12 weeks.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Starr, Ph.D. | Duke University Medical Center | 919-660-7571 | kathryn.starr@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2020 | Oct 11, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 25, 2022 | Sep 6, 2022 | ICF_000.pdf |
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Change in distance walked in six minutes from baseline
| 0 weeks, 12 weeks |
| Change in Body Weight as Measured by the Aria Fitbit Scale | Body weight in pounds. | 0 weeks, 12 weeks |
| Change in Average Weekly Steps Measured Using Garmin Watch | Average step counts using Garmin watch. | 0 weeks, 12 weeks |
| Change in Total Calories Using 3-day Food Record (Participants Record Everything They Eat and Drink for Three Days) | Average total calories consumed. | 0 weeks,12 weeks |
| Change in Stress Using the Perceived Stress Scale | 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. | 0 weeks, 12 weeks |
| Change in Self-reported Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D) | Score ranges from 0-60 with higher scores indicating greater depression symptoms. | 0 weeks, 12 weeks |
| Change in Mood Using the Profile of Mood States Questionnaire | 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". | 0 weeks, 12 weeks |
| Quality of Life Using the SF-36 Questionnaire - SF-36 Physical Functioning Scale | 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. | 0 weeks, 12 weeks |
| Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Physical Health Scale | 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 | 0 weeks, 12 weeks |
| Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Emotional Problems Scale | 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 | 0 weeks, 12 weeks |
| Quality of Life Using the SF-36 Questionnaire - Energy/Fatigue Scale | 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 | 0 weeks, 12 weeks |
| Quality of Life Using the SF-36 Questionnaire - Emotional Well-Being Scale | 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 | 0 weeks, 12 weeks |
| Quality of Life Using the SF-36 Questionnaire - Social Functioning Scale | 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. | 0 weeks, 12 weeks |
| Quality of Life Using the SF-36 Questionnaire - Pain Scale | 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. | 0 weeks, 12 weeks |
| Quality of Life Using the SF-36 Questionnaire - General Health Scale | 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 | 0 weeks, 12 weeks |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Acceptability as Measured by Participant Satisfaction | 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 | Participants who completed the study; data were not collected for one participant who completed. | Posted | Mean | Standard Deviation | score on a scale | 12 week endpoint |
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| Secondary | Change in Physical Performance as Measured by the Short Physical Performance Battery | Scores range from 0 to 12 with higher score indicating better performance. | Participants who completed the study; data were not collected for one participant who completed. | Posted | Mean | Standard Deviation | score on a scale | 0 weeks, 12 weeks |
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| Secondary | Change in Physical Function as Measured Using the 6 Minute Walk Test | Change in distance walked in six minutes from baseline | 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. | Posted | 0 weeks, 12 weeks |
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| Secondary | Change in Body Weight as Measured by the Aria Fitbit Scale | Body weight in pounds. | Participants who completed the study; data were not collected for one participant who completed. | Posted | Mean | Standard Deviation | pounds | 0 weeks, 12 weeks |
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| Secondary | Change in Average Weekly Steps Measured Using Garmin Watch | Average step counts using Garmin watch. | Participants who completed the study; data were not collected for one participant who completed. | Posted | Mean | Standard Deviation | steps per week | 0 weeks, 12 weeks |
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| Secondary | Change in Total Calories Using 3-day Food Record (Participants Record Everything They Eat and Drink for Three Days) | Average total calories consumed. | Posted | Mean | Standard Deviation | calories | 0 weeks,12 weeks |
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| Secondary | Change in Stress Using the Perceived Stress Scale | 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. | Participants who completed the study | Posted | Mean | Standard Deviation | score on a scale | 0 weeks, 12 weeks |
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| Secondary | Change in Self-reported Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D) | Score ranges from 0-60 with higher scores indicating greater depression symptoms. | Participants who completed the study | Posted | Mean | Standard Deviation | score on a scale | 0 weeks, 12 weeks |
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| Secondary | Change in Mood Using the Profile of Mood States Questionnaire | 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". | 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. | Posted | 0 weeks, 12 weeks |
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| Secondary | Quality of Life Using the SF-36 Questionnaire - SF-36 Physical Functioning Scale | 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. | Participants who completed the study | Posted | Mean | Standard Deviation | scores on a scale | 0 weeks, 12 weeks |
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| Secondary | Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Physical Health Scale | 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 | Participants who completed the study | Posted | Mean | Standard Deviation | scores on a scale | 0 weeks, 12 weeks |
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| Secondary | Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Emotional Problems Scale | 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 | Participants who completed the study | Posted | Mean | Standard Deviation | scores on a scale | 0 weeks, 12 weeks |
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| Secondary | Quality of Life Using the SF-36 Questionnaire - Energy/Fatigue Scale | 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 | Participants who completed the study | Posted | Mean | Standard Deviation | scores on a scale | 0 weeks, 12 weeks |
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| Secondary | Quality of Life Using the SF-36 Questionnaire - Emotional Well-Being Scale | 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 | Participants who completed the study | Posted | Mean | Standard Deviation | scores on a scale | 0 weeks, 12 weeks |
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| Secondary | Quality of Life Using the SF-36 Questionnaire - Social Functioning Scale | 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. | Participants who completed the study | Posted | Mean | Standard Deviation | scores on a scale | 0 weeks, 12 weeks |
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| Secondary | Quality of Life Using the SF-36 Questionnaire - Pain Scale | 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. | Participants who completed the study | Posted | Mean | Standard Deviation | scores on a scale | 0 weeks, 12 weeks |
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| Secondary | Quality of Life Using the SF-36 Questionnaire - General Health Scale | 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 | Participants who completed the study | Posted | Mean | Standard Deviation | scores on a scale | 0 weeks, 12 weeks |
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| 0 |
| 14 |
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