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

NeuroTherapia, Inc.

Status: Completed

Conditions: Obesity, Childhood

Treatments: Behavioral: Family Based Activity Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04312919

19-1339

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 2 patient groups

Intervention Group

Experimental group

Description:

3 in-person visit group

Treatment:

Behavioral: Family Based Activity Intervention

Control/Crossover Group

Active Comparator group

Description:

5 in-person visit group

Treatment:

Behavioral: Family Based Activity Intervention