AFRI Childhood Obesity Prevention Challenge Area

The Family Check-Up for Health: A Family-Centered Health Maintenance Approach to Improve Nutrition and Prevent Obesity in Early Childhood

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.

Study Overview

• Status: Completed
• Conditions: Clinical Trial
• Intervention / Treatment: Behavioral: Family Check-Up 4 Health; Other: Services as Usual

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 Type: Interventional
• Enrollment (Actual): 217
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Avondale, Arizona, United States, 852323
      • Avondale School District
    • Avondale, Arizona, United States, 85323
      • Bayless Integrated Healthcare
    • Avondale, Arizona, United States, 85323
      • Care1st Avondale Resource and Housing
    • Tempe, Arizona, United States, 85281
      • Arizona State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral: Family Check-Up 4 Health; Families will receive the FCU4Health program 3 times annually in a health maintenance model. The FCU4Health coordinator reviews the assessment results with the parents, using motivational interviewing 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.	Behavioral: Family Check-Up 4 Health; A parent-training intervention to improve child health, school readiness and manage obesity.; Other Names: FCU4Health
Experimental: Control-Services as Usual; Families will continue with their medical standard of care and referrals for services as appropriate from the healthcare staff in their respective FQHCs or primary healthcare clinics. Families will receive brochures about the community programs to which families in the FCU4Health arm are referred.	Other: Services as Usual; Services/Treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Family Health Behavior Scale	Family Mealtime Routines. Minimum Value: 0. Maximum Value: 20. Where higher scores mean a better outcome.	The investigators will examine trajectories of family mealtime routines over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Changes in the HABITS questionnaire	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.	The investigators will examine trajectories of child food and beverage choices over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Changes in the Family Health Behavior Scale	Child Eating Behaviors. Minimum Value: 0. Maximum Value: 20. Where higher scores mean a worse outcome.	The investigators will examine trajectories of child eating behaviors over 3 annual assessments (baseline, 1-year, 2-year follow-up).

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: Northwestern University
• Investigators: Principal Investigator: Justin D. Smith, Ph.D., Northwestern University; Principal Investigator: Cady Berkel, Ph.D., Arizona State University

Publications and helpful links

General Publications

• McEachern AD, Dishion TJ, Weaver CM, Shaw DS, Wilson MN, Gardner F. Parenting Young Children (PARYC): Validation of a Self-Report Parenting Measure. J Child Fam Stud. 2012 Jun;21(3):498-511. doi: 10.1007/s10826-011-9503-y.
• Crnic KA, Greenberg MT. Minor parenting stresses with young children. Child Dev. 1990 Oct;61(5):1628-37. doi: 10.1111/j.1467-8624.1990.tb02889.x.
• Stormshak EA, DeGarmo D, Garbacz SA, McIntyre LL, Caruthers A. Using Motivational Interviewing to Improve Parenting Skills and Prevent Problem Behavior During the Transition to Kindergarten. Prev Sci. 2021 Aug;22(6):747-757. doi: 10.1007/s11121-020-01102-w.
• Berkel C, Smith JD, Bruening MM, Jordan N, Fu E, Mauricio AM, Grimm KJ, Winslow E, Ray K, Bourne A, Dishion TJ. The Family Check-Up 4 Health: Study protocol of a randomized type II hybrid effectiveness-implementation trial in integrated primary care (the healthy communities 4 healthy students study). Contemp Clin Trials. 2020 Sep;96:106088. doi: 10.1016/j.cct.2020.106088. Epub 2020 Jul 22.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2017
• Primary Completion (Actual): January 29, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Implementation; Primary Care; Effectiveness; Parent Training; Fidelity; Cost-Effectiveness; Integrated Behavioral Health; Hybrid design; Family-Based Prevention; Family Check-Up 4 Health
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: FP00008342

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