Raising Healthy Children: A Hybrid Trial of the Family Check-Up 4 Health in Primary Care (FCU4Health)

August 2, 2024 updated by: Arizona State University

An Individually Tailored, Family-Centered Intervention for Childhood Obesity: Connecting Services in Pediatric Primary Healthcare, the Home and the Community

This study is a hybrid implementation-effectiveness trial of the Family Check-Up 4 Health (FCU4Health), an adapted version of the Family Check-Up, in pediatric primary care. Patients will be recruited based on their BMI as documented in the Electronic Health Record (EHR) and randomized to receive the FCU4Health or Treatment as Usual.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The FCU4Health is an assessment-driven, Motivational Interviewing (MI) based, parent training program. Parents and children complete a comprehensive assessment, including questionnaire and observation data. The FCU4Health coordinator reviews the assessment results with the parents, using MI strategies to create a tailored plan to address family needs. This plan may include referrals to community resources or parenting modules that focus on family management.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital
      • Phoenix, Arizona, United States, 85012
        • Terros Health
      • Phoenix, Arizona, United States, 85014
        • Valle del Sol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • BMI at or above 85% tile for age and gender

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Receives the Family Check-Up 4 Health
Behavioral: Family Check-Up 4 Health
A parent-training intervention to improve child health and prevent/manage obesity
Other Names:
  • FCU4Health
Experimental: Control
Receives Treatment as Usual
Other: Treatment as usual
Treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: The investigators will examine trajectories based on 4 assessments over one year
BMI
The investigators will examine trajectories based on 4 assessments over one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Composition
Time Frame: The investigators will examine trajectories based on 4 assessments over one year
% Body fat
The investigators will examine trajectories based on 4 assessments over one year
EuroQol-5D-5Level-Youth (EQ-5D-5L-Y)
Time Frame: The investigators will examine trajectories based on 4 assessments over one year
Quality of life
The investigators will examine trajectories based on 4 assessments over one year
PedsQL
Time Frame: The investigators will examine trajectories based on 4 assessments over one year
Quality of life
The investigators will examine trajectories based on 4 assessments over one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arizona State University

Collaborators

Northwestern University
University of Southern California
University of Washington

Investigators

  • Principal Investigator: Cady Berkel, Ph.D., Arizona State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2017

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

January 4, 2017

First Submitted That Met QC Criteria

January 5, 2017

First Posted (Estimated)

January 6, 2017

Study Record Updates

Last Update Posted (Actual)

August 5, 2024

Last Update Submitted That Met QC Criteria

August 2, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1U18DP006255-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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