BMI Study for Children Ages 6-9 Years and Parents

NCT ID: NCT02421822

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 487 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-14
• Study Completion Date: 2018-06-30

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Fitwits Intervention

Fitwits office tool and games

Group Type: EXPERIMENTAL

Fitwits office tool and games

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Ages 6-9 regardless of BMI status

Exclusion Criteria

• non-English-speaking

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Ann McGaffey

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ann L McGaffey, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC St.Margaret Bloomfield/Garfield Family Health Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO14080265

Identifier Type: -

Identifier Source: org_study_id