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Completed

NCT Number: NCT04490356

Enhancing Physical Function in the Long-term for 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.

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Key information

Conditions

Weight Loss Maintenance

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University, School of Medicine

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Legacy Intervention

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. 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

  3. Change in Body Weight as Measured by the Aria Fitbit Scale

    Time frame: 0 weeks, 12 weeks

    Body weight in pounds.

  4. Change in Average Weekly Steps Measured Using Garmin Watch

    Time frame: 0 weeks, 12 weeks

    Average step counts using Garmin watch.

  5. 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.

  6. 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.

  7. 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.

  8. 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".

  9. 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.

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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.

  15. 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.

  16. 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 29, 2020
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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