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Clinical Trials/NCT05123235
NCT05123235
Suspended
Not Applicable

The Effectiveness of a Telehealth-Based Physical Activity Intervention in Adolescents Receiving Treatment for Obesity

East Carolina University1 site in 1 country24 target enrollmentNovember 24, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physical Inactivity
Sponsor
East Carolina University
Enrollment
24
Locations
1
Primary Endpoint
Change in BMI percentile
Status
Suspended
Last Updated
2 years ago

Overview

Brief Summary

This study is a 11 week telehealth intervention focusing on increasing physical activity in adolescents who are receiving medical care for obesity. The participants will be randomized into two groups: control and intervention. During the 11 weeks both groups will be contacted once a week for a video call. The control group will report their past week physical activity levels and the intervention group will review the material in weekly newsletters on behavior changes related to physical activity. Physical activity levels will be measures before and after the intervention.

Detailed Description

The purpose of this study is to determine if a physical activity telehealth intervention will increase the amount of moderate-to-vigorous physical activity among 14-17 year olds who are receiving obesity treatment. A secondary purpose is to determine if a telehealth physical activity intervention will impact the adolescents' body mass index (BMI) z-score who are receiving treatment for obesity. The participants will complete questionnaires to measure current physical activity levels, physical activity enjoyment, motivation, and strategies to be active. The study investigators will also review the participants medical records to get BMI. Participants will be randomized into either an intervention or standard care control group at a 1:1 ratio (intervention-control). A computer-generated randomization list will be created by an individual not associated with the study. The intervention will last 11 weeks, and participants in the intervention group receive standard medical care and will have individual weekly web-meeting using a video conferencing platform, Microsoft Teams. The weekly meeting is expected to last approximately 30 minutes. During this meeting, participants will report on the past week's physical activity goals, failures and successes, set goals for the next week, discuss that week's behavioral strategy to promote physical activity for that week, and engage around 5 minutes of physical activity. The topics that will be discussed in the newsletters and weekly meetings will include behavioral strategies for physical activity changes. Those in the control group will also receive standard medical care and be contacted weekly for 11 weeks and will be asked about their physical activity levels for the past week. These meetings will also occur using video conferencing and last 5 minutes. After a regular visit to the medical clinic (6 weeks from the 1st study visit) the study investigators will review medical records from all participants for height, weight, and BMI. About 12 weeks after the 1st study visit, during a regular clinic visit all participants will complete questionnaires to measure current physical activity levels, physical activity enjoyment, motivation, and strategies to be active. The study investigators will also review the participants medical records to get height, weight and BMI.

Registry
clinicaltrials.gov
Start Date
November 24, 2021
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 14-17 years of age
  • receiving treatment for obesity
  • have a smart device for video conferencing

Exclusion Criteria

  • under 14 years of age
  • Type 1 or Type 2 Diabetes
  • Neuromuscular disease that impacts moving
  • Parent or child unable to speak or write in English.

Outcomes

Primary Outcomes

Change in BMI percentile

Time Frame: weeks 1, 6, and 12

BMI percentile will be calculated from BMI and CDC normative data

Change in physical activity participation

Time Frame: weeks 1 and 12

minutes spent in physical activity

Change in BMI z-score

Time Frame: weeks 1, 6, and 12

BMI z-score will be calculated from BMI and CDC normative data

Secondary Outcomes

  • Change in physical activity enjoyment(weeks 1 and 12)
  • Change in physical activity motivation(weeks 1 and 12)
  • Change in physical activity strategies(weeks 1 and 12)

Study Sites (1)

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