AFRI Childhood Obesity Prevention Challenge Area

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-17

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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The FCU4Health is an assessment-driven, Motivational Interviewing (MI) based, parent training program. Parents complete a comprehensive assessment, including questionnaire of the family environment, parenting skills, and child adjustment and health behaviors, and additional observation data. The FCU4Health coordinator reviews the assessment results with the parents, using MI strategies to engage families in making change to support child behavioral health, and to create tailored follow-up services which include parent training modules and referrals to additional support services in the community.

Conditions

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Clinical Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Behavioral: Family Check-Up 4 Health

Families will receive the FCU4Health program 3 times annually in a health maintenance model. The FCU4Health coordinator reviews the assessment results with the parents, using motivational interviewing 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.

Group Type EXPERIMENTAL

Family Check-Up 4 Health

Intervention Type BEHAVIORAL

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

Control-Services as Usual

Families will continue with their medical standard of care and referrals for services as appropriate from the healthcare staff in their respective FQHCs or primary healthcare clinics.

Families will receive brochures about the community programs to which families in the FCU4Health arm are referred.

Group Type EXPERIMENTAL

Services as Usual

Intervention Type OTHER

Services/Treatment as usual.

Interventions

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Family Check-Up 4 Health

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

Intervention Type BEHAVIORAL

Services as Usual

Services/Treatment as usual.

Intervention Type OTHER

Other Intervention Names

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FCU4Health

Eligibility Criteria

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Inclusion Criteria

* Participating caregiver who is at least 18 years of age and understands English and/or Spanish well enough to complete study assessment.

Exclusion Criteria

* Two exceptions: (1) Children with special needs that preclude engagement in a nutrition-based behavioral intervention (e.g., g-tube dependence) and (2) children who are in state custody.

Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes