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

The Cleveland Clinic1 site in 1 country63 target enrollmentFebruary 3, 2020

ConditionsObesity, Childhood

Overview

Phase: N/A
Intervention: Not specified
Conditions: Obesity, Childhood
Sponsor: The Cleveland Clinic
Enrollment: 63
Locations: 1
Primary Endpoint: Exercise Capacity
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 3, 2020

End Date

September 27, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The Cleveland Clinic

Responsible Party

Principal Investigator

Andrea Mucci

Associate Staff Physician

The Cleveland Clinic

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Exercise Capacity

Time Frame: Change from Baseline Six Minute Walk Distance through study completion (up to 33 weeks)

6 minute walk distance

Secondary Outcomes

Fitbit Data(Change in steps per day wearing Fitbit and after 1 week Goal Setting Steps)
Height(Change from Baseline height through study completion (up to 33 weeks))
Weight(Change from Baseline weight through study completion (up to 33 weeks))