Effectiveness of a Telehealth-based Physical Activity Intervention

NCT05123235 | Suspended

• 1 other identifier: 21-001684
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Inactivity; Obesity, Childhood

Outcome Measures

Primary Outcomes (3)

• Change in physical activity participation

  minutes spent in physical activity

  weeks 1 and 12

• Change in BMI z-score

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

  weeks 1, 6, and 12

• Change in BMI percentile

  BMI percentile will be calculated from BMI and CDC normative data

  weeks 1, 6, and 12

Secondary Outcomes (3)

• 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 Arms (2)

Physical Activity

EXPERIMENTAL

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.

Behavioral: Physical Activity

Control

NO INTERVENTION

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.

Interventions

Physical Activity 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.

Physical Activity

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27858, United States

Location

MeSH Terms

Conditions

Sedentary Behavior; Pediatric Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Katrina D DuBose, PhD

  East Carolina University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Physical activity group and a control group

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 17, 2021
• Study Start: November 24, 2021
• Primary Completion: February 15, 2022
• Study Completion: December 31, 2025
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)