Raising Healthy Children: A Hybrid Trial of the Family Check-Up 4 Health in Primary Care

Study Overview
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Brief Summary
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This study is a hybrid implementation-effectiveness 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 BMI as documented in the Electronic Health Record (EHR) and randomized to receive the FCU4Health or Treatment as Usual.

Detailed Description
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The FCU4Health is an assessment-driven, Motivational Interviewing (MI) based, parent training program. Parents and children complete a comprehensive assessment, including questionnaire and observation data. The FCU4Health coordinator reviews the assessment results with the parents, using MI 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.

Official Title
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An Individually Tailored, Family-Centered Intervention for Childhood Obesity: Connecting Services in Pediatric Primary Healthcare, the Home and the Community

Conditions
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Clinical Trial

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI at or above 85% tile for age and gender Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Intervention<br>Receives the Family Check-Up 4 Health | Behavioral: Family Check-Up 4 Health<br>* A parent-training intervention to improve child health and prevent/manage obesity<br>* Other names: FCU4Health;|
| Experimental: Control<br>Receives Treatment as Usual | Other: Treatment as usual<br>* Treatment as usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | BMI | The investigators will examine trajectories based on 4 assessments over one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition | % Body fat | The investigators will examine trajectories based on 4 assessments over one year | 
| EuroQol-5D-5Level-Youth (EQ-5D-5L-Y) | Quality of life | The investigators will examine trajectories based on 4 assessments over one year | 
| PedsQL | Quality of life | The investigators will examine trajectories based on 4 assessments over one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implementation, Hybrid, Effectiveness, Parent training, Fidelity, Cost-Effectiveness, Primary Care