BMI Study for Children Ages 6-9 Years and Parents

Childhood Obesity Clinical Trial

Official title:

BMI Study for Children Ages 6-9 Years and Parents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02421822
• Other study ID #: PRO14080265
• Status: Completed
• Phase: N/A
• Start date: June 14, 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 487
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

Inclusion Criteria:

• Ages 6-9 regardless of BMI status

Exclusion Criteria:

• non-English-speaking

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Other:
• Fitwits office tool and games
Physician-led narration of Fitwits office tool during well child and subsequent visits over one year with distribution of Fitwits games during first visit.

Locations

Country	Name	City	State
United States	UPMC St.Margaret Bloomfield/Garfield Family Health Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved parent correct identification of child BMI category (surveys)	improved correctness of BMI category selection on surveys over one year	one year