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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03013309
Acronym
FCU4Health
Enrollment
240
Registered
2017-01-06
Start date
2017-05-09
Completion date
2024-06-30
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Trial

Keywords

Hybrid, Implementation, Effectiveness, Parent training, Fidelity, Cost-Effectiveness, Primary Care

Brief summary

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

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.

Interventions

A parent-training intervention to improve child health and prevent/manage obesity

OTHERTreatment as usual

Treatment as usual

Sponsors

Northwestern University
CollaboratorOTHER
University of Washington
CollaboratorOTHER
University of Southern California
CollaboratorOTHER
Arizona State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* BMI at or above 85% tile for age and gender

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
BMIThe investigators will examine trajectories based on 4 assessments over one yearBMI

Secondary

MeasureTime frameDescription
Body CompositionThe investigators will examine trajectories based on 4 assessments over one year% Body fat
EuroQol-5D-5Level-Youth (EQ-5D-5L-Y)The investigators will examine trajectories based on 4 assessments over one yearQuality of life
PedsQLThe investigators will examine trajectories based on 4 assessments over one yearQuality of life

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026