Clinical trial NCT05123235: 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
Overall status: SUSPENDED
Phase: NA
Conditions: Physical Inactivity
Obesity, Childhood
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 24
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Physical activity group and a control group
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in physical activity participation
timeFrame: weeks 1 and 12
measure: Change in BMI z-score
timeFrame: weeks 1, 6, and 12
measure: Change in BMI percentile
timeFrame: weeks 1, 6, and 12
Secondary outcomes:
measure: Change in physical activity enjoyment
timeFrame: weeks 1 and 12
measure: Change in physical activity motivation
timeFrame: weeks 1 and 12
measure: Change in physical activity strategies
timeFrame: weeks 1 and 12
Other outcomes:
Locations:
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
Study officials:
affiliation: East Carolina University
name: Katrina D DuBose, PhD
role: PRINCIPAL_INVESTIGATOR
References: