AFRI Childhood Obesity Prevention Challenge Area

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Clinical Trial

Intervention / Treatment
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* Behavioral: Family Check-Up 4 Health
* Other: Services as Usual


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral: Family Check-Up 4 Health<br>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<br>* A parent-training intervention to improve child health, school readiness and manage obesity.<br>* Other names: FCU4Health;|
| Experimental: Control-Services as Usual<br>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<br>* Services/Treatment as usual.<br>|

What is the study measuring?
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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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hybrid design, Implementation, Effectiveness, Parent Training, Cost-Effectiveness, Primary Care, Integrated Behavioral Health, Family-Based Prevention, Family Check-Up 4 Health, Fidelity