Obesity, Childhood
Conditions
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.
Interventions
BEHAVIORALFamily 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.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Capacity | Change from Baseline Six Minute Walk Distance through study completion (up to 33 weeks) | 6 minute walk distance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight | Change from Baseline weight through study completion (up to 33 weeks) | weight measured in kilograms |
| 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 |
Countries
United States
Outcome results
None listed