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Completed

NCT Number: NCT04469816

AFRI Childhood Obesity Prevention Challenge Area

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.

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Key information

Conditions

Clinical Trial

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Avondale School District, Avondale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Family Check-Up 4 Health

Behavioral

A parent-training intervention to improve child health, school readiness and manage obesity.

Other names: FCU4Health

Services as Usual

Other

Services/Treatment as usual.

Primary outcomes

  1. Changes in the Family Health Behavior Scale

    Time frame: The investigators will examine trajectories of family mealtime routines over 3 annual assessments (baseline, 1-year, 2-year follow-up).

    Family Mealtime Routines. Minimum Value: 0. Maximum Value: 20. Where higher scores mean a better outcome.

  2. Changes in the HABITS questionnaire

    Time frame: 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.

  3. Changes in the Family Health Behavior Scale

    Time frame: 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.

Secondary outcomes

  1. Strengths and Difficulties Questionnaire

    Time frame: The investigators will examine trajectories of child conduct problems over 3 annual assessments (baseline, 1-year, 2-year follow-up).

    Conduct Problems. Minimum Value: 0. Maximum Value: 2. Where higher scores mean a worse outcome.

  2. Children's Behavior Questionnaire

    Time frame: 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.

  3. Strengths and Difficulties Questionnaire

    Time frame: The investigators will examine trajectories of prosocial behavior over 3 annual assessments (baseline, 1-year, 2-year follow-up).

    Prosocial Behavior. Minimum Value: 0. Maximum Value: 2. Where higher scores mean a better outcome.

  4. Strengths and Difficulties Questionnaire

    Time frame: 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.

  5. Brief Infant Sleep Questionnaire

    Time frame: 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.

  6. Media Parenting Scale

    Time frame: 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.

  7. The Family Health Behavior Scale

    Time frame: 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.

  8. Trajectories of Community Action for Successful Youth Measure (See Reference Section for citing of title)

    Time frame: The investigators will examine trajectories of parenting warmth over 3 annual assessments (baseline, 1-year, 2-year follow-up).

    Parenting Warmth. Minimum Value: 1. Maximum Value: 25. Where higher scores mean a worse outcome.

  9. Trajectories of Community Action for Successful Youth Measure (See Reference Section for citing of title)

    Time frame: 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.

  10. Child-parent relationship scale

    Time frame: 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.

  11. Center for Epidemiologic Studies Depression Scale

    Time frame: 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.

  12. Trajectories of Parenting Daily Hassles (See Reference Section for citing of title)

    Time frame: 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.

  13. Tool for Substance Use Screening

    Time frame: 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.

  14. Trajectories of Parenting Young Children (See Reference Section for citing of title)

    Time frame: The investigators will examine trajectories of incentive and encouragement over 3 annual assessments (baseline, 1-year, 2-year follow-up).

    Incentive and Encouragement. Minimum Value: 0. Maximum Value: 4. Where higher scores mean a better outcome.

  15. Trajectories of Parenting Young Children (See Reference Section for citing of title)

    Time frame: The investigators will examine trajectories of proactive parenting over 3 annual assessments (baseline, 1-year, 2-year follow-up).

    Proactive Parenting. Minimum Value: 0. Maximum Value: 4. Where higher scores mean a better outcome.

  16. Trajectories of Parenting Young Children (See Reference Section for citing of title)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • Northwestern University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jul 14, 2020
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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