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Clinical Trials/NCT04490356
NCT04490356
Completed
Not Applicable

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

Duke University1 site in 1 country14 target enrollmentApril 26, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Weight Loss Maintenance
Sponsor
Duke University
Enrollment
14
Locations
1
Primary Endpoint
Acceptability as Measured by Participant Satisfaction
Status
Completed
Last Updated
10 months ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
April 26, 2021
End Date
September 16, 2022
Last Updated
10 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • 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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Change in Physical Performance as Measured by the Short Physical Performance Battery(0 weeks, 12 weeks)
  • Change in Physical Function as Measured Using the 6 Minute Walk Test(0 weeks, 12 weeks)
  • Change in Body Weight as Measured by the Aria Fitbit Scale(0 weeks, 12 weeks)
  • Change in Average Weekly Steps Measured 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)(0 weeks,12 weeks)
  • Change in Stress Using the Perceived Stress Scale(0 weeks, 12 weeks)
  • Change in Self-reported Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D)(0 weeks, 12 weeks)
  • Change in Mood Using the Profile of Mood States Questionnaire(0 weeks, 12 weeks)
  • Quality of Life Using the SF-36 Questionnaire - SF-36 Physical Functioning Scale(0 weeks, 12 weeks)
  • Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Physical Health Scale(0 weeks, 12 weeks)
  • Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Emotional Problems Scale(0 weeks, 12 weeks)
  • Quality of Life Using the SF-36 Questionnaire - Energy/Fatigue Scale(0 weeks, 12 weeks)
  • Quality of Life Using the SF-36 Questionnaire - Emotional Well-Being Scale(0 weeks, 12 weeks)
  • Quality of Life Using the SF-36 Questionnaire - Social Functioning Scale(0 weeks, 12 weeks)
  • Quality of Life Using the SF-36 Questionnaire - Pain Scale(0 weeks, 12 weeks)
  • Quality of Life Using the SF-36 Questionnaire - General Health Scale(0 weeks, 12 weeks)

Study Sites (1)

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