Back to resultsEnhancing Physical Function in the Long-term for Older Adults
Primary Purpose
Weight Loss Maintenance
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Legacy Intervention
Sponsored by
About this trial
This is an interventional other trial for Weight Loss Maintenance
Eligibility Criteria
Inclusion Criteria:
- Participated in a weight loss intervention in the last 9 months and lost ≥ 3% body weight and improved SPPB score by ≥ 1 point or 6MWT by ≥ 50 meters
- Age ≥ 60
- Able to speak and understand spoken and written English.
- Able to record dietary intake and weight
Exclusion Criteria:
- Presence of unstable or symptomatic life-threatening illness
- Neurological conditions causing functional impairment, including Parkinson's disease, multiple sclerosis, and permanent disability due to stroke
- Inability to complete physical function assessment
- No access to internet connection to participate in the tele-intervention
- Unable or unwilling to use provided tablet to participant in tele-intervention
- History of cognitive impairment
Sites / Locations
- Duke University, School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Legacy Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
Retention
Completion of at least 85% of tele-nutrition and tele-exercise intervention
Acceptability as measured by Participant Satisfaction
Participants will asked to rate their satisfaction using a five point likert scale (very dissatisfied; dissatisfied; neutral; satisfied; very satisfied) on a) satisfaction with the delivery of the tele-nutrition intervention, b) satisfaction with the delivery of the tele-exercise intervention c) satisfaction with their ability to maintain their physical function d) satisfaction with their ability to maintain their weight loss e) satisfaction with interactions with the registered dietitian.
Secondary Outcome Measures
Change in physical performance as measured by the Short Physical Performance Battery
Change score of Short Physical Performance Battery score from baseline, 6 and 12 weeks
Change in physical function as measured using the 6 minute walk test
Change score for distance walked in six minutes from baseline
Change in body weight as measured by the Aria Fitbit Scale
Change score for body weight from baseline, 6 and 12 weeks
Change in Body mass as measured by the Aria Fitbit Scale (%)
Change score for percent body mass from baseline, 6 and 12 weeks
Change in average weekly steps measured using Garmin watch
Using Garmin watch to determine average weekly step count over 12 weeks study and compare change in weekly step count over time.
Change in total calories using 3-day food record (participants record everything they eat and drink for three days
Change score for total calories will be measured using 3-day food records from baseline, 6 and 12 weeks
Change in macronutrients using 3-day food record (participants record everything they eat and drink for three days
Macronutrient intake will be measured using 3-day food records from baseline, 6 and 12 weeks
Change in Stress using the Perceived Stress Scale
Change score for stress from baseline, 6 and 12 weeks. Perceived Stress Scale is a a 12-item stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Change in Self-reported Depression using the Center for Epidemiologic Studies Depression Scale (CES-D)
Change score for self-reported depression from baseline, 6 and 12 weeks.
Change in Mood using the Profile of Mood States questionnaire
Change score for 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".
Change in quality of life using the SF-36 questionnaire
Change score for the Physical and Mental composite scores from baseline 0, 6, and 12 weeks.
Full Information
NCT ID
NCT04490356
First Posted
July 24, 2020
Last Updated
September 15, 2023
Sponsor
Duke University
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04490356
Brief Title
Enhancing Physical Function in the Long-term for Older Adults
Official Title
Extending Legacy Benefits of Obesity Reduction in Older Adults: A Novel Telehealth Intervention Using Nutrition and Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Suspended
Why Stopped
Awaiting additional funding to enroll additional participants
Study Start Date
April 26, 2021 (Actual)
Primary Completion Date
September 16, 2022 (Actual)
Study Completion Date
November 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss Maintenance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Legacy Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Legacy Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Retention
Description
Completion of at least 85% of tele-nutrition and tele-exercise intervention
Time Frame
12 week endpoint
Title
Acceptability as measured by Participant Satisfaction
Description
Participants will asked to rate their satisfaction using a five point likert scale (very dissatisfied; dissatisfied; neutral; satisfied; very satisfied) on a) satisfaction with the delivery of the tele-nutrition intervention, b) satisfaction with the delivery of the tele-exercise intervention c) satisfaction with their ability to maintain their physical function d) satisfaction with their ability to maintain their weight loss e) satisfaction with interactions with the registered dietitian.
Time Frame
12 week endpoint
Secondary Outcome Measure Information:
Title
Change in physical performance as measured by the Short Physical Performance Battery
Description
Change score of Short Physical Performance Battery score from baseline, 6 and 12 weeks
Time Frame
0, 6, 12 weeks
Title
Change in physical function as measured using the 6 minute walk test
Description
Change score for distance walked in six minutes from baseline
Time Frame
0, 6, 12 weeks
Title
Change in body weight as measured by the Aria Fitbit Scale
Description
Change score for body weight from baseline, 6 and 12 weeks
Time Frame
0, 6, 12 weeks
Title
Change in Body mass as measured by the Aria Fitbit Scale (%)
Description
Change score for percent body mass from baseline, 6 and 12 weeks
Time Frame
0, 6, 12 weeks
Title
Change in average weekly steps measured using Garmin watch
Description
Using Garmin watch to determine average weekly step count over 12 weeks study and compare change in weekly step count over time.
Time Frame
Every week for 12 weeks
Title
Change in total calories using 3-day food record (participants record everything they eat and drink for three days
Description
Change score for total calories will be measured using 3-day food records from baseline, 6 and 12 weeks
Time Frame
0, 6, 12 weeks
Title
Change in macronutrients using 3-day food record (participants record everything they eat and drink for three days
Description
Macronutrient intake will be measured using 3-day food records from baseline, 6 and 12 weeks
Time Frame
0, 6, 12 weeks
Title
Change in Stress using the Perceived Stress Scale
Description
Change score for stress from baseline, 6 and 12 weeks. Perceived Stress Scale is a a 12-item stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Time Frame
0, 6, 12 weeks
Title
Change in Self-reported Depression using the Center for Epidemiologic Studies Depression Scale (CES-D)
Description
Change score for self-reported depression from baseline, 6 and 12 weeks.
Time Frame
0, 6, 12 weeks
Title
Change in Mood using the Profile of Mood States questionnaire
Description
Change score for 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".
Time Frame
0, 6, 12 weeks
Title
Change in quality of life using the SF-36 questionnaire
Description
Change score for the Physical and Mental composite scores from baseline 0, 6, and 12 weeks.
Time Frame
0, 6, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participated in a weight loss intervention in the last 9 months and lost ≥ 3% body weight and improved SPPB score by ≥ 1 point or 6MWT by ≥ 50 meters
Age ≥ 60
Able to speak and understand spoken and written English.
Able to record dietary intake and weight
Exclusion Criteria:
Presence of unstable or symptomatic life-threatening illness
Neurological conditions causing functional impairment, including Parkinson's disease, multiple sclerosis, and permanent disability due to stroke
Inability to complete physical function assessment
No access to internet connection to participate in the tele-intervention
Unable or unwilling to use provided tablet to participant in tele-intervention
History of cognitive impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Starr, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University, School of Medicine
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Enhancing Physical Function in the Long-term for Older Adults
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