Enhancing Physical Function in the Long-term for Older Adults

Extending Legacy Benefits of Obesity Reduction in Older Adults: A Novel Telehealth Intervention Using Nutrition and Exercise

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: Suspended
• Conditions: Weight Loss Maintenance
• Intervention / Treatment: Behavioral: Legacy Intervention

• Study Type: Interventional
• Enrollment (Estimated): 24
• 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
Retention	Completion of at least 85% of tele-nutrition and tele-exercise intervention	12 week endpoint
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.	12 week endpoint

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	0, 6, 12 weeks
Change in physical function as measured using the 6 minute walk test	Change score for distance walked in six minutes from baseline	0, 6, 12 weeks
Change in body weight as measured by the Aria Fitbit Scale	Change score for body weight from baseline, 6 and 12 weeks	0, 6, 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	0, 6, 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.	Every week for 12 weeks
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	0, 6, 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	0, 6, 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.	0, 6, 12 weeks
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.	0, 6, 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".	0, 6, 12 weeks
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.	0, 6, 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 (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

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): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• 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