Enhancing Physical Function in the Long-term for Older Adults

A Novel Telehealth Intervention Using Nutrition and Exercise to Extend Intervention Benefits: Enhancing Physical Function in the Long-term for Obese Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss Maintenance
• Intervention / Treatment: Behavioral: Legacy Intervention

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Kathryn Starr, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2021
• Primary Completion (Actual): September 16, 2022
• Study Completion (Actual): September 16, 2022

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 9, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: PRO00105630; 1P30AG064201-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No