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CompletedNCT04312919CCFitUpdated Feb 1, 2024

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

An interventional study of Family Based Activity Intervention in Obesity, Childhood, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-02-01.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
8 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity, Childhood
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 63 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Be Well patient
  • Age 8*-18 years
  • BMI > 95%ile
  • English speaking

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    Intervention Group

    3 in-person visit group

    Behavioral: Family Based Activity Intervention

  • Active comparator
    Control/Crossover Group

    5 in-person visit group

    Behavioral: Family Based Activity Intervention

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.

06

What researchers measure

Primary outcomes

  1. Exercise Capacity

    6 minute walk distance

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

Secondary outcomes

  1. Weight

    weight measured in kilograms

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

  2. Fitbit Data

    Steps per Day

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

  3. Height

    height measured in centimeters

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

07

Study locations

1 site
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04312919
Lead sponsor
The Cleveland Clinic
Responsible party
Andrea Mucci (Associate Staff Physician, The Cleveland Clinic) — Principal investigator
First posted
Mar 18, 2020
Start date
Feb 3, 2020
Primary completion
Sep 27, 2021
Completion
Sep 27, 2021
Last update
Feb 1, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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