NCT02421822

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
487

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 14, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

3 years

First QC Date

March 26, 2015

Last Update Submit

July 16, 2018

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (1)

  • Improved parent correct identification of child BMI category (surveys)

    improved correctness of BMI category selection on surveys over one year

    one year

Study Arms (1)

Fitwits Intervention

EXPERIMENTAL

Fitwits office tool and games

Other: Fitwits office tool and games

Interventions

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.

Fitwits Intervention

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Ages 6-9 regardless of BMI status

You may not qualify if:

  • non-English-speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC St.Margaret Bloomfield/Garfield Family Health Center

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ann L McGaffey, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 26, 2015

First Posted

April 21, 2015

Study Start

June 14, 2015

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations

US(1)