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

Clinical Trial Clinical Trial

— FCU4Health  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03013309
• Other study ID #: 1U18DP006255-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 9, 2017
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2023
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: June 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Clinical Trial

Intervention

Behavioral:
• Family Check-Up 4 Health
A parent-training intervention to improve child health and prevent/manage obesity

Other:
• Treatment as usual
Treatment as usual

Locations

Country	Name	City	State
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Terros Health	Phoenix	Arizona
United States	Valle del Sol	Phoenix	Arizona

Sponsors (4)

Lead Sponsor	Collaborator
Arizona State University	Northwestern University, University of Southern California, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI	BMI	The investigators will examine trajectories based on 4 assessments over one year
Secondary	Body Composition	% Body fat	The investigators will examine trajectories based on 4 assessments over one year
Secondary	EuroQol-5D-5Level-Youth (EQ-5D-5L-Y)	Quality of life	The investigators will examine trajectories based on 4 assessments over one year
Secondary	PedsQL	Quality of life	The investigators will examine trajectories based on 4 assessments over one year