Cleveland Clinic Families Get Fit (CCFit) : A Family-based Activity-Monitor Intervention in Pediatric Obesity

Obesity, Childhood Clinical Trial

— CCFit  

Official title:

Cleveland Clinic Families Get Fit (CCFit) : A Family-based Activity-Monitor Intervention in Pediatric Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04312919
• Other study ID #: 19-1339
• Status: Completed
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: September 27, 2021

Study information

• Verified date: January 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized prospective study to evaluate the effectiveness of a family-based intervention using activity-monitors (I.e. Fitbits) in children and adolescents aged 8-18 years with a BMI greater than or equal to 95%ile who attend the Cleveland Clinic multidisciplinary "Be Well" pediatric obesity clinic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 27, 2021
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• Be Well patient
• Age 8*-18 years
• BMI > 95%ile
• English speaking

Exclusion Criteria:

• Uncontrolled asthma
• Orthopedic or other medical issue limiting mobility
• Participant has worn an activity-monitor in the past 6 months (ok if parents wear)

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• Family Based Activity Intervention
Providing youth and their families with access to the knowledge and resources to increase their physical activity will allow them to lead more healthy lifestyles will provide them with the foundation for a healthier life, and future ahead.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise Capacity	6 minute walk distance	Change from Baseline Six Minute Walk Distance through study completion (up to 33 weeks)
Secondary	Weight	weight measured in kilograms	Change from Baseline weight through study completion (up to 33 weeks)
Secondary	Fitbit Data	Steps per Day	Change in steps per day wearing Fitbit and after 1 week Goal Setting Steps
Secondary	Height	height measured in centimeters	Change from Baseline height through study completion (up to 33 weeks)