Effectiveness of a Telehealth-based Physical Activity Intervention

NCT ID: NCT05123235

Last Updated: 2023-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-24

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Physical Inactivity Obesity, Childhood

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Physical activity group and a control group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Physical Activity

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.

Group Type EXPERIMENTAL

Physical Activity

Intervention Type BEHAVIORAL

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.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

East Carolina University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Katrina D DuBose, PhD

Role: PRINCIPAL_INVESTIGATOR

East Carolina University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

East Carolina University

Greenville, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

21-001684

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Remote Exercise Program for Rural Men
NCT07224217 RECRUITING NA
Goal Setting and Lifestyle
NCT01110213 COMPLETED NA