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OpenTrials
Completed

NCT Number: NCT04312919

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

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.

Completed

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Key information

Conditions

Obesity, Childhood Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Family Based Activity Intervention

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.

Primary outcomes

  1. Exercise Capacity

    Time frame: Change from Baseline Six Minute Walk Distance through study completion (up to 33 weeks)

    6 minute walk distance

Secondary outcomes

  1. Weight

    Time frame: Change from Baseline weight through study completion (up to 33 weeks)

    weight measured in kilograms

  2. Fitbit Data

    Time frame: Change in steps per day wearing Fitbit and after 1 week Goal Setting Steps

    Steps per Day

  3. Height

    Time frame: Change from Baseline height through study completion (up to 33 weeks)

    height measured in centimeters

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Acronym: CCFit

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 18, 2020
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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