AFRI Childhood Obesity Prevention Challenge Area

Not Applicable

Completed

• Conditions: Clinical Trial

• Registration Number: NCT04469816
• Lead Sponsor: Arizona State University

Brief Summary

This study is a hybrid type 2 effectiveness-implementation 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 age (2-5 years old) and randomized to receive the intervention, FCU4Health, or services as usual. All families will be assessed annually over three years.

Detailed Description

The FCU4Health is an assessment-driven, Motivational Interviewing (MI) based, parent training program. Parents complete a comprehensive assessment, including questionnaire of the family environment, parenting skills, and child adjustment and health behaviors, and additional observation data. The FCU4Health coordinator reviews the assessment results with the parents, using MI strategies to engage families in making change to support child behavioral health, and to create tailored follow-up services which include parent training modules and referrals to additional support services in the community.

Study Timeline

• Study Start: 2017-05-17
• Study First Submitted: 2020-06-26
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-14
• Primary Completion: 2024-01-29
• Study Completion: 2024-01-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

Inclusion Criteria

• Participating caregiver who is at least 18 years of age and understands English and/or Spanish well enough to complete study assessment.

Exclusion Criteria

• Two exceptions: (1) Children with special needs that preclude engagement in a nutrition-based behavioral intervention (e.g., g-tube dependence) and (2) children who are in state custody.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in the Family Health Behavior Scale	The investigators will examine trajectories of child eating behaviors over 3 annual assessments (baseline, 1-year, 2-year follow-up).	Child Eating Behaviors. Minimum Value: 0. Maximum Value: 20. Where higher scores mean a worse outcome.
Changes in the HABITS questionnaire	The investigators will examine trajectories of child food and beverage choices over 3 annual assessments (baseline, 1-year, 2-year follow-up).	Child Food and Beverage Choices. Food Minimum Value: 0. Maximum Value: 24. Where higher food scores mean a better outcome and higher beverage scores mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Children's Behavior Questionnaire	The investigators will examine trajectories of child effortful control over 3 annual assessments (baseline, 1-year, 2-year follow-up).	Effortful Control. Minimum Value: 1. Maximum Value: 5. Where higher scores mean a better outcome.
Center for Epidemiologic Studies Depression Scale	The investigators will examine trajectories of parent depression over 3 annual assessments (baseline, 1-year, 2-year follow-up).	Depression. Minimum Value: 0. Maximum Value: 80. Where higher scores mean a worse outcome.
Trajectories of Parenting Young Children (See Reference Section for citing of title)	The investigators will examine trajectories of parent limit setting over 3 annual assessments (baseline, 1-year, 2-year follow-up).	Limit Setting. Minimum Value: 0. Maximum Value: 4. Where higher scores mean a better outcome.
Tool for Substance Use Screening	The investigators will examine trajectories of parent substance use over 3 annual assessments (baseline, 1-year, 2-year follow-up).	Parent Substance Use. Minimum Value: 0. Maximum Value: 1. Where higher scores mean a worse outcome.
Strengths and Difficulties Questionnaire	The investigators will examine trajectories of emotional problems over 3 annual assessments (baseline, 1-year, 2-year follow-up).	Emotional Problems. Minimum Value: 0. Maximum Value: 2. Where higher scores mean a worse outcome.
The Family Health Behavior Scale	The investigators will examine trajectories of child physical activity habits over 3 annual assessments (baseline, 1-year, 2-year follow-up).	Child Physical Activity Habits. Minimum Value: 0. Maximum Value: 24. Where higher scores mean a better outcome.
Child-parent relationship scale	The investigators will examine trajectories of parent child conflict over 3 annual assessments (baseline, 1-year, 2-year follow-up).	Parent Child Conflict. Minimum Value: 1. Maximum Value: 25. Where higher scores mean a worse outcome.
Media Parenting Scale	The investigators will examine trajectories of child media routines over 3 annual assessments (baseline, 1-year, 2-year follow-up).	Media Routines. Minimum Value: 0. Maximum Value: 24. Where higher scores mean a better outcome.
Trajectories of Community Action for Successful Youth Measure (See Reference Section for citing of title)	The investigators will examine trajectories of family conflict over 3 annual assessments (baseline, 1-year, 2-year follow-up).	Family Conflict. Minimum Value: 0. Maximum Value: 6. Where higher scores mean a worse outcome.
Trajectories of Parenting Daily Hassles (See Reference Section for citing of title)	The investigators will examine trajectories of parenting stress over 3 annual assessments (baseline, 1-year, 2-year follow-up).	Parenting Stress. Minimum Value: 1. Maximum Value: 4. Where higher scores mean a worse outcome.
Brief Infant Sleep Questionnaire	The investigators will examine trajectories of child sleep routines over 3 annual assessments (baseline, 1-year, 2-year follow-up).	Sleep Routines. Minimum Value: 0. Maximum Value: 24. Where higher scores mean a better outcome.

Trial Locations

Locations (4)

Avondale School District; 🇺🇸 Avondale, Arizona, United States

Bayless Integrated Healthcare; 🇺🇸 Avondale, Arizona, United States

Care1st Avondale Resource and Housing; 🇺🇸 Avondale, Arizona, United States

Arizona State University; 🇺🇸 Tempe, Arizona, United States