Enhancing Physical Function in the Long-term for Older Adults

Not Applicable

Suspended

• Conditions: Weight Loss Maintenance
• Interventions: Behavioral: Legacy Intervention

• Registration Number: NCT04490356
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-29
• Study Start: 2021-04-26
• Disposition First Submitted: 2023-09-15
• Disposition First Posted: 2023-10-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-29
• Last Update Posted: 2024-04-02
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Legacy Intervention	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.

Primary Outcome Measures

Name	Time	Method
Retention	12 week endpoint	Completion of at least 85% of tele-nutrition and tele-exercise intervention
Acceptability as measured by Participant Satisfaction	12 week endpoint	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

Name	Time	Method
Change in body weight as measured by the Aria Fitbit Scale	0, 6, 12 weeks	Change score for body weight from baseline, 6 and 12 weeks
Change in physical function as measured using the 6 minute walk test	0, 6, 12 weeks	Change score for distance walked in six minutes from baseline
Change in average weekly steps measured using Garmin watch	Every week for 12 weeks	Using Garmin watch to determine average weekly step count over 12 weeks study and compare change in weekly step count over time.
Change in Self-reported Depression using the Center for Epidemiologic Studies Depression Scale (CES-D)	0, 6, 12 weeks	Change score for self-reported depression from baseline, 6 and 12 weeks.
Change in quality of life using the SF-36 questionnaire	0, 6, 12 weeks	Change score for the Physical and Mental composite scores from baseline 0, 6, and 12 weeks.
Change in total calories using 3-day food record (participants record everything they eat and drink for three days	0, 6, 12 weeks	Change score for total calories will be measured using 3-day food records from baseline, 6 and 12 weeks
Change in Body mass as measured by the Aria Fitbit Scale (%)	0, 6, 12 weeks	Change score for percent body mass from baseline, 6 and 12 weeks
Change in physical performance as measured by the Short Physical Performance Battery	0, 6, 12 weeks	Change score of Short Physical Performance Battery score from baseline, 6 and 12 weeks
Change in macronutrients using 3-day food record (participants record everything they eat and drink for three days	0, 6, 12 weeks	Macronutrient intake will be measured using 3-day food records from baseline, 6 and 12 weeks
Change in Stress using the Perceived Stress Scale	0, 6, 12 weeks	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 Mood using the Profile of Mood States questionnaire	0, 6, 12 weeks	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".

Trial Locations

Locations (1)

Duke University, School of Medicine; 🇺🇸 Durham, North Carolina, United States