Weight Loss MaintenanceNCT04490356
Enhancing Physical Function in the Long-term for Older Adults
A study testing Legacy Intervention in people with Weight Loss Maintenance, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Loss Maintenance
- What is being tested?
- Legacy Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2021to 16 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University, School of Medicine
Durham, North Carolina, 27710
About this study
Official title: 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.
- Conditions
- Weight Loss Maintenance
- Being tested
- Legacy Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Legacy InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Legacy Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 week endpoint
Secondary outcomes (16)
Change in Physical Performance as Measured by the Short Physical Performance Battery
Scores range from 0 to 12 with higher score indicating better performance.
Measured: 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
Measured: 0 weeks, 12 weeks
Change in Body Weight as Measured by the Aria Fitbit Scale
Body weight in pounds.
Measured: 0 weeks, 12 weeks
Change in Average Weekly Steps Measured Using Garmin Watch
Average step counts using Garmin watch.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 0 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start26 Apr 2021
- Primary completion16 Sep 2022
- Study completion16 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Weight Loss MaintenanceStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Kathryn Starr, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490356
- Sponsor's protocol ID
- PRO00105630
- Other IDs
- 1P30AG064201-01
- Status last verified
- Mar 2024
- First submitted
- 24 Jul 2020
- Last updated
- 26 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Telehealth Intervention Using Nutrition and Exercise to Extend Intervention Benefits: Enhancing Physical Function in the Long-term for Obese Older Adults
- ClinicalTrials.gov ID
- NCT04490356
- Acronym / sponsor ID
- PRO00105630
- Conditions
- Weight Loss Maintenance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 16 Sep 2022 (actual)
- Study completion
- 16 Sep 2022 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Posted 26 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Legacy Intervention | Experimental | Behavioral: Legacy InterventionOlder 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Legacy InterventionThe 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. | Behavioural | Legacy Intervention |
Primary outcome
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
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
16 secondary outcomes
Change in Physical Performance as Measured by the Short Physical Performance Battery
Time frame: 0 weeks, 12 weeks
Change in Physical Function as Measured Using the 6 Minute Walk Test
Time frame: 0 weeks, 12 weeks
Change in Body Weight as Measured by the Aria Fitbit Scale
Time frame: 0 weeks, 12 weeks
Change in Average Weekly Steps Measured Using Garmin Watch
Time frame: 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
Change in Stress Using the Perceived Stress Scale
Time frame: 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
Change in Mood Using the Profile of Mood States Questionnaire
Time frame: 0 weeks, 12 weeks
Quality of Life Using the SF-36 Questionnaire - SF-36 Physical Functioning Scale
Time frame: 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
Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Emotional Problems Scale
Time frame: 0 weeks, 12 weeks
Quality of Life Using the SF-36 Questionnaire - Energy/Fatigue Scale
Time frame: 0 weeks, 12 weeks
Quality of Life Using the SF-36 Questionnaire - Emotional Well-Being Scale
Time frame: 0 weeks, 12 weeks
Quality of Life Using the SF-36 Questionnaire - Social Functioning Scale
Time frame: 0 weeks, 12 weeks
Quality of Life Using the SF-36 Questionnaire - Pain Scale
Time frame: 0 weeks, 12 weeks
Quality of Life Using the SF-36 Questionnaire - General Health Scale
Time frame: 0 weeks, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Starr, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Legacy Intervention in people with Weight Loss Maintenance, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion Retention (time frame: 12 week endpoint). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.