AFRI Childhood Obesity Prevention Challenge Area

Arizona State University217 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

217

Conditions

Clinical Trial

Interventions

Family Check-Up 4 HealthBEHAVIORAL

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

Services as UsualOTHER

Services/Treatment as usual.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 5 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

Changes in the Family Health Behavior Scale

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

Time frame: 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.

Time frame: 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.

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

Secondary Outcomes

Strengths and Difficulties Questionnaire

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

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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