Raising Healthy Children: A Hybrid Trial of the Family Check-Up 4 Health in Primary Care (FCU4Health)

Arizona State University (ASU)

Status: Completed

Conditions: Clinical Trial

Treatments: Behavioral: Family Check-Up 4 Health; Other: Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT03013309

1U18DP006255-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Intervention

Experimental group

Description:

Receives the Family Check-Up 4 Health

Treatment:

Behavioral: Family Check-Up 4 Health

Control

Experimental group

Description:

Receives Treatment as Usual

Treatment:

Other: Treatment as usual