Enhancing Physical Function in the Long-term for Older Adults

NCT04490356 | Completed Results

• 2 other identifiers: PRO001056301P30AG064201-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss Maintenance

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (16)

• Change in Physical Performance as Measured by the Short Physical Performance Battery

  0 weeks, 12 weeks

• Change in Physical Function as Measured Using the 6 Minute Walk Test

  0 weeks, 12 weeks

• Change in Body Weight as Measured by the Aria Fitbit Scale

  0 weeks, 12 weeks

• Change in Average Weekly Steps Measured 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)

  0 weeks,12 weeks

Study Arms (1)

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.

Behavioral: Legacy Intervention

Interventions

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.

Legacy Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Duke University, School of Medicine

Durham, North Carolina, 27710, United States

Location

Limitations and Caveats

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.

Results Point of Contact

• Title: Kathryn Starr, Ph.D.
• Organization: Duke University Medical Center

kathryn.starr@duke.edu

919-660-7571

Study Officials

• Kathryn Starr, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: July 29, 2020
• Study Start: April 26, 2021
• Primary Completion: September 16, 2022
• Study Completion: September 16, 2022
• Last Updated: June 26, 2025
• Results First Posted: June 26, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)