Obesity, ChildhoodCCFitNCT04312919
Cleveland Clinic Families Get Fit (CCFit) : A Family-based Activity-Monitor Intervention in Pediatric Obesity
A study testing Family Based Activity Intervention in people with Obesity, Childhood, run by The Cleveland Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Family Based Activity Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2020to 27 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Be Well patient
- Age 8*-18 years
- BMI > 95%ile
- English speaking
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Obesity, Childhood
- Being tested
- Family Based Activity Intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Based Activity InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 3 in-person visit group Receives: Behavioral: Family Based Activity Intervention |
| Control/Crossover Group | Active comparator | 5 in-person visit group Receives: Behavioral: Family Based Activity Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity
6 minute walk distance
Measured: Change from Baseline Six Minute Walk Distance through study completion (up to 33 weeks)
Secondary outcomes (3)
Weight
weight measured in kilograms
Measured: Change from Baseline weight through study completion (up to 33 weeks)
Fitbit Data
Steps per Day
Measured: Change in steps per day wearing Fitbit and after 1 week Goal Setting Steps
Height
height measured in centimeters
Measured: Change from Baseline height through study completion (up to 33 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start3 Feb 2020
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Mucci, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312919
- Sponsor's protocol ID
- 19-1339
- Acronym
- CCFit
- Status last verified
- Jan 2024
- First submitted
- 13 Mar 2020
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cleveland Clinic Families Get Fit (CCFit) : A Family-based Activity-Monitor Intervention in Pediatric Obesity
- ClinicalTrials.gov ID
- NCT04312919
- Acronym / sponsor ID
- CCFit / 19-1339
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Family Based Activity Intervention3 in-person visit group |
| Control/Crossover Group | Active comparator | Behavioral: Family Based Activity Intervention5 in-person visit group |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Be Well patient
- Age 8*-18 years
- BMI > 95%ile
- English speaking
Key exclusion criteria (3 listed)
- Uncontrolled asthma
- Orthopedic or other medical issue limiting mobility
- Participant has worn an activity-monitor in the past 6 months (ok if parents wear)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Based Activity InterventionProviding 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. | Behavioural | Control/Crossover Group, Intervention Group |
Primary outcome
Exercise Capacity
Time frame: Change from Baseline Six Minute Walk Distance through study completion (up to 33 weeks)
6 minute walk distance
3 secondary outcomes
Weight
Time frame: Change from Baseline weight through study completion (up to 33 weeks)
Fitbit Data
Time frame: Change in steps per day wearing Fitbit and after 1 week Goal Setting Steps
Height
Time frame: Change from Baseline height through study completion (up to 33 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Based Activity Intervention in people with Obesity, Childhood, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Capacity (time frame: Change from Baseline Six Minute Walk Distance through study completion (up to 33 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.