Enhancing Physical Function in the Long-term for Older Adults

June 9, 2025 updated by: Duke University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion Retention
Time Frame: 12 week endpoint
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
Time Frame: 12 week endpoint
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Physical Performance as Measured by the Short Physical Performance Battery
Time Frame: 0 weeks, 12 weeks
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
Time Frame: 0 weeks, 12 weeks
Change in distance walked in six minutes from baseline
0 weeks, 12 weeks
Change in Body Weight as Measured by the Aria Fitbit Scale
Time Frame: 0 weeks, 12 weeks
Body weight in pounds.
0 weeks, 12 weeks
Change in Average Weekly Steps Measured Using Garmin Watch
Time Frame: 0 weeks, 12 weeks
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)
Time Frame: 0 weeks,12 weeks
Average total calories consumed.
0 weeks,12 weeks
Change in Stress Using the Perceived Stress Scale
Time Frame: 0 weeks, 12 weeks
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)
Time Frame: 0 weeks, 12 weeks
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
Time Frame: 0 weeks, 12 weeks
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
Time Frame: 0 weeks, 12 weeks
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
Time Frame: 0 weeks, 12 weeks
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
Time Frame: 0 weeks, 12 weeks
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
Time Frame: 0 weeks, 12 weeks
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
Time Frame: 0 weeks, 12 weeks
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
Time Frame: 0 weeks, 12 weeks
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
Time Frame: 0 weeks, 12 weeks
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
Time Frame: 0 weeks, 12 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kathryn Starr, PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 26, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 16, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 16, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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