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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04312919
Other study ID # 19-1339
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 3, 2020
Est. completion date September 27, 2021

Study information

Verified date January 2024
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date September 27, 2021
Est. primary completion date September 27, 2021
Accepts healthy volunteers No
Gender All
Age group 8 Years to 18 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Exercise Capacity 6 minute walk distance Change from Baseline Six Minute Walk Distance through study completion (up to 33 weeks)
Secondary Weight weight measured in kilograms Change from Baseline weight through study completion (up to 33 weeks)
Secondary Fitbit Data Steps per Day Change in steps per day wearing Fitbit and after 1 week Goal Setting Steps
Secondary Height height measured in centimeters Change from Baseline height through study completion (up to 33 weeks)
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