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

NCT ID: NCT04312919

Last Updated: 2024-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-03

Study Completion Date

2021-09-27

Brief Summary

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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

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Conditions

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Obesity, Childhood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention Group

3 in-person visit group

Group Type EXPERIMENTAL

Family Based Activity Intervention

Intervention Type BEHAVIORAL

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.

Control/Crossover Group

5 in-person visit group

Group Type ACTIVE_COMPARATOR

Family Based Activity Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Andrea Mucci

Associate Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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19-1339

Identifier Type: -

Identifier Source: org_study_id

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