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Behavioral Intervention

FCU4Health for Reducing Heart Disease Risk in Children (PREVAIL 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 percentile for age and gender

Must not have

N/A

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6, month 16, month 24

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a program called Family Check-Up 4 Health (FCU4Health) can help reduce the risk of heart disease in children. They are using a mix of different methods

Who is the study for?

This trial is for children at risk of cardiovascular disease. It's being conducted in primary care settings and aims to help improve health behaviors, parenting skills, and potentially reduce child BMI.

What is being tested?

The study tests the FCU4Health intervention combined with tech strategies like a fidelity monitoring system (Lyssn) and text messages (CAMPI), all integrated with Electronic Health Records to see if they can lower heart disease risks in kids.

What are the potential side effects?

Since this trial involves behavioral interventions and technology use rather than medication, traditional side effects are not expected. However, there may be privacy concerns or stress related to participation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My BMI is in the top 15% for my age and gender.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

Not applicable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6, month 16, month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6, month 16, month 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6, month 16, month 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Budget impact of implementation

Child Health Behaviors: Dietary Screener Questionnaire

Cost-effectiveness of FCU4Health

+2 more

Secondary study objectives

COACH Fidelity Rating System

Child BMI - Percentage of the 95th percentile (BMIp95)

Engagement (participation) in FCU4Health services

+15 more

Other study objectives

Satisfaction with FCU4Health Parent Service

Satisfaction with FCU4Health Parent-Coordinator

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: SMS/Text (CAMPI) and Fidelity Monitoring System (Lyssn)Experimental Treatment3 Interventions

Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform. Receives automated fidelity monitoring and interactive feedback reports. Receives Family Check-Up 4 Health (FCU4Health) parenting intervention.

Group II: SMS/Text (CAMPI)Experimental Treatment2 Interventions

Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform. Receives Family Check-Up 4 Health (FCU4Health) parenting intervention.

Group III: No CAMPI or LyssnExperimental Treatment1 Intervention

Receives neither SMS/Text (CAMPI) or Fidelity Monitoring System (Lyssn). Receives Family Check-Up 4 Health (FCU4Health) parenting intervention.

Group IV: Fidelity Monitoring System (Lyssn)Experimental Treatment2 Interventions

Receives automated fidelity monitoring and interactive feedback reports. Receives Family Check-Up 4 Health (FCU4Health) parenting intervention.

0 / 2Eligibility criteria met