Effectiveness of a Telehealth-based Physical Activity Intervention

Physical Inactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05123235
• Other study ID #: 21-001684
• Status: Suspended
• Phase: N/A
• Start date: November 24, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 24
• Est. completion date: December 31, 2025
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

• Pregnant

• Type 1 or Type 2 Diabetes

• Neuromuscular disease that impacts moving

• Parent or child unable to speak or write in English.

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity
• Physical Inactivity

Intervention

Behavioral:
• Physical Activity
the participants will be encouraged to set their own physical activity goals weekly and using behavioral strategies work towards meeting those goals. The behavioral strategies will be discussed weekly for 30 minutes a telehealth method.

Locations

Country	Name	City	State
United States	East Carolina University	Greenville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
East Carolina University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in physical activity participation	minutes spent in physical activity	weeks 1 and 12
Primary	Change in BMI z-score	BMI z-score will be calculated from BMI and CDC normative data	weeks 1, 6, and 12
Primary	Change in BMI percentile	BMI percentile will be calculated from BMI and CDC normative data	weeks 1, 6, and 12
Secondary	Change in physical activity enjoyment	physical activity enjoyment scale - Likert rating from 1-5 a higher total summary score means more enjoyment	weeks 1 and 12
Secondary	Change in physical activity motivation	motivation to exercise scale, Likert scale 1-5 where 1=not very true for me to 5=very true for me; 5 different subscales are calculated: amotivation, external regulation, introjected regulation, identified regulation, and intrinsic motivation	weeks 1 and 12
Secondary	Change in physical activity strategies	physical activity self management questionnaire, Likert scale 1-5 where 1=not very often to 5=very often. A higher score means that the person uses more posititve self management strategies to engage in physical activity	weeks 1 and 12