search
Back to results

Effectiveness of a Telehealth-based Physical Activity Intervention

Primary Purpose

Physical Inactivity, Obesity, Childhood

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity
Sponsored by
East Carolina University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physical Inactivity

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • East Carolina University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physical Activity

Control

Arm Description

The intervention will last 11 weeks, and participants in the intervention group will have individual weekly web-meeting using a video conferencing platform. 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 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.

During the 11 weeks the participants in the control group will have a weekly check in meeting using a video conferencing platform. The weekly meeting is expected to last approximately 5 minutes. During this meeting, participants will report on the past week's physical activity levels.

Outcomes

Primary Outcome Measures

Change in physical activity participation
minutes spent in physical activity
Change in BMI z-score
BMI z-score will be calculated from BMI and CDC normative data
Change in BMI percentile
BMI percentile will be calculated from BMI and CDC normative data

Secondary Outcome Measures

Change in physical activity enjoyment
physical activity enjoyment scale - Likert rating from 1-5 a higher total summary score means more enjoyment
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
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

Full Information

First Posted
October 26, 2021
Last Updated
June 6, 2023
Sponsor
East Carolina University
search

1. Study Identification

Unique Protocol Identification Number
NCT05123235
Brief Title
Effectiveness of a Telehealth-based Physical Activity Intervention
Official Title
The Effectiveness of a Telehealth-Based Physical Activity Intervention in Adolescents Receiving Treatment for Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Suspended
Why Stopped
After starting to recruit it became apparent that the participants did not want to participate in a telehealth intervention.
Study Start Date
November 24, 2021 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
East Carolina University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Inactivity, Obesity, Childhood

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Physical activity group and a control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical Activity
Arm Type
Experimental
Arm Description
The intervention will last 11 weeks, and participants in the intervention group will have individual weekly web-meeting using a video conferencing platform. 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 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
During the 11 weeks the participants in the control group will have a weekly check in meeting using a video conferencing platform. The weekly meeting is expected to last approximately 5 minutes. During this meeting, participants will report on the past week's physical activity levels.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in physical activity participation
Description
minutes spent in physical activity
Time Frame
weeks 1 and 12
Title
Change in BMI z-score
Description
BMI z-score will be calculated from BMI and CDC normative data
Time Frame
weeks 1, 6, and 12
Title
Change in BMI percentile
Description
BMI percentile will be calculated from BMI and CDC normative data
Time Frame
weeks 1, 6, and 12
Secondary Outcome Measure Information:
Title
Change in physical activity enjoyment
Description
physical activity enjoyment scale - Likert rating from 1-5 a higher total summary score means more enjoyment
Time Frame
weeks 1 and 12
Title
Change in physical activity motivation
Description
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
Time Frame
weeks 1 and 12
Title
Change in physical activity strategies
Description
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
Time Frame
weeks 1 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 Pregnant Type 1 or Type 2 Diabetes Neuromuscular disease that impacts moving Parent or child unable to speak or write in English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrina D DuBose, PhD
Organizational Affiliation
East Carolina University
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of a Telehealth-based Physical Activity Intervention

We'll reach out to this number within 24 hrs