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

January 31, 2024 updated by: Andrea Mucci, The Cleveland Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
3 in-person visit group
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.
Active Comparator: Control/Crossover Group
5 in-person visit group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Capacity
Time Frame: Change from Baseline Six Minute Walk Distance through study completion (up to 33 weeks)
6 minute walk distance
Change from Baseline Six Minute Walk Distance through study completion (up to 33 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Change from Baseline weight through study completion (up to 33 weeks)
weight measured in kilograms
Change from Baseline weight through study completion (up to 33 weeks)
Fitbit Data
Time Frame: Change in steps per day wearing Fitbit and after 1 week Goal Setting Steps
Steps per Day
Change in steps per day wearing Fitbit and after 1 week Goal Setting Steps
Height
Time Frame: Change from Baseline height through study completion (up to 33 weeks)
height measured in centimeters
Change from Baseline height through study completion (up to 33 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2020

Primary Completion (Actual)

September 27, 2021

Study Completion (Actual)

September 27, 2021

Study Registration Dates

First Submitted

March 13, 2020

First Submitted That Met QC Criteria

March 16, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-1339

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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