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

Sponsor

Arizona State University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03013309

Collaborator

Northwestern University (Other), University of Washington (Other), University of Southern California (Other)

240

Enrollment

Locations

Arms

60.7

Anticipated Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Clinical Trial	Behavioral: Family Check-Up 4 Health Other: Treatment as usual	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 9, 2017

Actual Primary Completion Date :

Sep 6, 2019

Anticipated Study Completion Date :

May 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

BMI [The investigators will examine trajectories based on 4 assessments over one year]
BMI

Secondary Outcome Measures

Body Composition [The investigators will examine trajectories based on 4 assessments over one year]
% Body fat
EuroQol-5D-5Level-Youth (EQ-5D-5L-Y) [The investigators will examine trajectories based on 4 assessments over one year]
Quality of life
PedsQL [The investigators will examine trajectories based on 4 assessments over one year]
Quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

BMI at or above 85% tile for age and gender

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Terros Health	Phoenix	Arizona	United States	85012
2	Valle del Sol	Phoenix	Arizona	United States	85014
3	Phoenix Children's Hospital	Phoenix	Arizona	United States	85016