Enhancing Physical Function in the Long-term for Older Adults

NCT ID: NCT04490356

Last Updated: 2025-06-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-26

Study Completion Date

2022-09-16

Brief Summary

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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

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Conditions

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Weight Loss Maintenance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Legacy Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathryn Starr, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University, School of Medicine

Durham, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1P30AG064201-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO00105630

Identifier Type: -

Identifier Source: org_study_id

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