Back to resultsCleveland Clinic Families Get Fit (CCFit) : A Family-based Activity-Monitor Intervention in Pediatric Obesity (CCFit)
Primary Purpose
Obesity, Childhood
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Based Activity Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Obesity, Childhood
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)
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Group
Control/Crossover Group
Arm Description
3 in-person visit group
5 in-person visit group
Outcomes
Primary Outcome Measures
Exercise Capacity
6 minute walk distance
Secondary Outcome Measures
Weight
weight measured in kilograms
Fitbit Data
Steps per Day
Height
height measured in centimeters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04312919
Brief Title
Cleveland Clinic Families Get Fit (CCFit) : A Family-based Activity-Monitor Intervention in Pediatric Obesity
Acronym
CCFit
Official Title
Cleveland Clinic Families Get Fit (CCFit) : A Family-based Activity-Monitor Intervention in Pediatric Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
September 27, 2021 (Actual)
Study Completion Date
September 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
3 in-person visit group
Arm Title
Control/Crossover Group
Arm Type
Active Comparator
Arm Description
5 in-person visit group
Intervention Type
Behavioral
Intervention Name(s)
Family Based Activity Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Exercise Capacity
Description
6 minute walk distance
Time Frame
Change from Baseline Six Minute Walk Distance through study completion (up to 33 weeks)
Secondary Outcome Measure Information:
Title
Weight
Description
weight measured in kilograms
Time Frame
Change from Baseline weight through study completion (up to 33 weeks)
Title
Fitbit Data
Description
Steps per Day
Time Frame
Change in steps per day wearing Fitbit and after 1 week Goal Setting Steps
Title
Height
Description
height measured in centimeters
Time Frame
Change from Baseline height through study completion (up to 33 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cleveland Clinic Families Get Fit (CCFit) : A Family-based Activity-Monitor Intervention in Pediatric Obesity
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