Cleveland Clinic Families Get Fit (CCFit) : A Family-based Activity-Monitor Intervention in Pediatric Obesity
Not Applicable
Completed
- Conditions
- Obesity, Childhood
- Interventions
- Behavioral: Family Based Activity Intervention
- Registration Number
- NCT04312919
- Lead Sponsor
- The Cleveland Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Family Based Activity Intervention 3 in-person visit group Control/Crossover Group Family Based Activity Intervention 5 in-person visit group
- Primary Outcome Measures
Name Time Method Exercise Capacity Change from Baseline Six Minute Walk Distance through study completion (up to 33 weeks) 6 minute walk distance
- Secondary Outcome Measures
Name Time Method Fitbit Data Change in steps per day wearing Fitbit and after 1 week Goal Setting Steps Steps per Day
Height Change from Baseline height through study completion (up to 33 weeks) height measured in centimeters
Weight Change from Baseline weight through study completion (up to 33 weeks) weight measured in kilograms
Trial Locations
- Locations (1)
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States