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

Not Applicable

Completed

• Conditions: Clinical Trial
• Interventions: Behavioral: Family Check-Up 4 Health; Other: Treatment as usual

• Registration Number: NCT03013309
• Lead Sponsor: Arizona State University

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.

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 Timeline

• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-06
• Study Start: 2017-05-09
• Primary Completion: 2023-12-30
• Study Completion: 2024-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Family Check-Up 4 Health	Receives the Family Check-Up 4 Health
Control	Treatment as usual	Receives Treatment as Usual

Primary Outcome Measures

Name	Time	Method
BMI	The investigators will examine trajectories based on 4 assessments over one year	BMI

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Valle del Sol; 🇺🇸 Phoenix, Arizona, United States

Terros Health; 🇺🇸 Phoenix, Arizona, United States

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States