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Behavioral Intervention
Family Check-Up 4 Health for Pediatric Weight Management (FCU4Health Trial)
N/A
Waitlist Available
Led By Cady Berkel, Ph.D.
Research Sponsored by Arizona State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
BMI at or above 85% tile for age and gender
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the investigators will examine trajectories based on 4 assessments over one year
Awards & highlights
FCU4Health Trial Summary
This trial is testing whether the FCU4Health, an adapted version of the Family Check-Up, is effective 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.
Who is the study for?
This trial is for children with a BMI at or above the 85th percentile for their age and gender, indicating they may be overweight. The study aims to help these kids through primary care settings.Check my eligibility
What is being tested?
The study is testing the Family Check-Up 4 Health (FCU4Health) program against standard care. Kids will be randomly chosen to either get this new health program or continue with their usual treatments.See study design
What are the potential side effects?
Since FCU4Health is a behavioral intervention rather than a medication, it doesn't have typical drug side effects. However, participants might experience changes in behavior or family dynamics.
FCU4Health Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFCU4Health Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the investigators will examine trajectories based on 4 assessments over one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the investigators will examine trajectories based on 4 assessments over one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
BMI
Secondary outcome measures
Body Composition
EuroQol-5D-5Level-Youth (EQ-5D-5L-Y)
PedsQL
FCU4Health Trial Design
2Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Receives the Family Check-Up 4 Health
Group II: ControlExperimental Treatment1 Intervention
Receives Treatment as Usual
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaOTHER
906 Previous Clinical Trials
1,595,809 Total Patients Enrolled
University of WashingtonOTHER
1,744 Previous Clinical Trials
1,848,137 Total Patients Enrolled
1 Trials studying Clinical Trials
843 Patients Enrolled for Clinical Trials
Northwestern UniversityOTHER
1,592 Previous Clinical Trials
917,802 Total Patients Enrolled
1 Trials studying Clinical Trials
200 Patients Enrolled for Clinical Trials
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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