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AFRI Childhood Obesity Prevention Challenge Area

NCT04469816 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2025-05-25

No results posted yet for this study

Summary

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.

Conditions

  • Clinical Trial

Interventions

BEHAVIORAL

Family Check-Up 4 Health

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

OTHER

Services as Usual

Services/Treatment as usual.

Sponsors & Collaborators

Principal Investigators

  • Cady Berkel, Ph.D. · Arizona State University

  • Justin D. Smith, Ph.D. · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-17
Primary Completion
2024-01-29
Completion
2024-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04469816 on ClinicalTrials.gov