Childhood ObesityNCT02421822
BMI Study for Children Ages 6-9 Years and Parents
A study testing Fitwits office tool and games in people with Childhood Obesity, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to test the Fitwits office tool and games with 6-9 year old children and their parents to: 1) assist parent-child dyad with correct BMI status identification and understanding; 2) address nutrition, portion size, and activity cues; and, 3) track BMI trajectory over 12-month period. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Fitwits office tool and games
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 487 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2015to 30 Jun 2018
- 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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ages 6-9 regardless of BMI status
Who cannot join
- non-English-speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC St.Margaret Bloomfield/Garfield Family Health Center
Pittsburgh, Pennsylvania, 15206
About this study
The purpose of this study is to test the Fitwits office tool and games with 6-9 year old children and their parents to: 1) assist parent-child dyad with correct BMI status identification and understanding; 2) address nutrition, portion size, and activity cues; and, 3) track BMI trajectory over 12-month period.
Read the detailed description
The investigators will study parents' perceptions of their child's BMI before and after the Fitwits intervention with a primary goal of improving parents' ability to identify their child's actual BMI status (underweight, healthy weight, overweight, or obese). Secondary goals are to measure changes in behaviors and BMI trajectories with repetitive use of the Fitwits office tool.
The study design is a longitudinal non-randomized intervention study with four time points (baseline, 3, 6, and 12 months). The investigators will recruit family medicine residents, fellows, and faculty at the investigators' three family health centers and enroll 150 parent/guardians and children aged 6-9 years at well child visits, regardless of initial BMI.
The investigators will use electronic health record-generated BMI percentages, the physician-led Fitwits Office Tool as the intervention, and self-reported surveys for the parent-child dyad. Surveys will record the BMI understanding -pre- and post-Fitwits intervention at each visit.
The investigators will compare the intervention to a control group residency-based family health center with usual care for child/parent dyads presenting at well child care and 12 months later. At this site the investigators will survey for correct parent identification of the child's BMI category.
- Conditions
- Childhood Obesity
- Being tested
- Fitwits office tool and games
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitwits office tool and gamesOther
Physician-led narration of Fitwits office tool during well child and subsequent visits over one year with distribution of Fitwits games during first visit.
| Study group | Role | What they receive |
|---|---|---|
| Fitwits Intervention | Experimental | Fitwits office tool and games Receives: Other: Fitwits office tool and games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved parent correct identification of child BMI category (surveys)
improved correctness of BMI category selection on surveys over one year
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study start14 Jun 2015
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 487 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann McGaffey, University of Pittsburgh
- Investigators
- Ann L McGaffey, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421822
- Sponsor's protocol ID
- PRO14080265
- Status last verified
- Jul 2018
- First submitted
- 26 Mar 2015
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BMI Study for Children Ages 6-9 Years and Parents
- ClinicalTrials.gov ID
- NCT02421822
- Acronym / sponsor ID
- PRO14080265
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 487 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 14 Jun 2015 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 21 Apr 2015 (estimated)
- 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.
The purpose of this study is to test the Fitwits office tool and games with 6-9 year old children and their parents to: 1) assist parent-child dyad with correct BMI status identification and understanding; 2) address nutrition, portion size, and activity cues; and, 3) track BMI trajectory over 12-month period.
Detailed description
The investigators will study parents' perceptions of their child's BMI before and after the Fitwits intervention with a primary goal of improving parents' ability to identify their child's actual BMI status (underweight, healthy weight, overweight, or obese). Secondary goals are to measure changes in behaviors and BMI trajectories with repetitive use of the Fitwits office tool.
The study design is a longitudinal non-randomized intervention study with four time points (baseline, 3, 6, and 12 months). The investigators will recruit family medicine residents, fellows, and faculty at the investigators' three family health centers and enroll 150 parent/guardians and children aged 6-9 years at well child visits, regardless of initial BMI.
The investigators will use electronic health record-generated BMI percentages, the physician-led Fitwits Office Tool as the intervention, and self-reported surveys for the parent-child dyad. Surveys will record the BMI understanding -pre- and post-Fitwits intervention at each visit.
The investigators will compare the intervention to a control group residency-based family health center with usual care for child/parent dyads presenting at well child care and 12 months later. At this site the investigators will survey for correct parent identification of the child's BMI category.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fitwits Intervention | Experimental | Other: Fitwits office tool and gamesFitwits office tool and games |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Ages 6-9 regardless of BMI status
Key exclusion criteria (1 listed)
- non-English-speaking
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 |
|---|---|---|
| Fitwits office tool and gamesPhysician-led narration of Fitwits office tool during well child and subsequent visits over one year with distribution of Fitwits games during first visit. | Other | Fitwits Intervention |
Primary outcome
Improved parent correct identification of child BMI category (surveys)
Time frame: one year
improved correctness of BMI category selection on surveys over one year
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 18 Jul 2018.
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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.
Ann L McGaffey, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitwits office tool and games in people with Childhood Obesity, run by University of Pittsburgh 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 1 inclusion and 1 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 18 Jul 2018. 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?
Improved parent correct identification of child BMI category (surveys) (time frame: one year). 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 18 Jul 2018.