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

NCT ID: NCT03013309

Last Updated: 2024-08-05

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

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-09

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

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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Intervention

Receives the Family Check-Up 4 Health

Group Type EXPERIMENTAL

Family Check-Up 4 Health

Intervention Type BEHAVIORAL

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

Control

Receives Treatment as Usual

Group Type EXPERIMENTAL

Treatment as usual

Intervention Type OTHER

Treatment as usual

Interventions

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Family Check-Up 4 Health

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

Intervention Type BEHAVIORAL

Treatment as usual

Treatment as usual

Intervention Type OTHER

Other Intervention Names

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FCU4Health

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role collaborator

Arizona State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cady Berkel, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

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Terros Health

Phoenix, Arizona, United States

Site Status

Valle del Sol

Phoenix, Arizona, United States

Site Status

Phoenix Children's Hospital

Phoenix, Arizona, United States

Site Status

Countries

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United States

References

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Berkel C, Knox DC, Flemotomos N, Martinez VR, Atkins DC, Narayanan SS, Rodriguez LA, Gallo CG, Smith JD. A machine learning approach to improve implementation monitoring of family-based preventive interventions in primary care. Implement Res Pract. 2023 Jul 25;4:26334895231187906. doi: 10.1177/26334895231187906. eCollection 2023 Jan-Dec.

Reference Type DERIVED
PMID: 37790171 (View on PubMed)

Harris A, Jordan N, Carroll AJ, Graham AK, Wilson C, Wilson FA, Berkel C, Smith JD. A budget impact analysis of cost to implement a whole child health focused, family-based intervention in primary care for children with elevated BMI. Implement Sci Commun. 2023 Jun 5;4(1):59. doi: 10.1186/s43058-023-00429-z.

Reference Type DERIVED
PMID: 37277878 (View on PubMed)

Smith JD, Carroll AJ, Fu E, Berkel C. Baseline Targeted Moderation in a Trial of the Family Check-Up 4 Health: Potential Explanations for Finding Few Practical Effects. Prev Sci. 2023 Feb;24(2):226-236. doi: 10.1007/s11121-021-01266-z. Epub 2021 Jun 22.

Reference Type DERIVED
PMID: 34159507 (View on PubMed)

Berkel C, Fu E, Carroll AJ, Wilson C, Tovar-Huffman A, Mauricio A, Rudo-Stern J, Grimm KJ, Dishion TJ, Smith JD. Effects of the Family Check-Up 4 Health on Parenting and Child Behavioral Health: A Randomized Clinical Trial in Primary Care. Prev Sci. 2021 May;22(4):464-474. doi: 10.1007/s11121-021-01213-y. Epub 2021 Mar 14.

Reference Type DERIVED
PMID: 33715136 (View on PubMed)

Smith JD, Berkel C, Jordan N, Atkins DC, Narayanan SS, Gallo C, Grimm KJ, Dishion TJ, Mauricio AM, Rudo-Stern J, Meachum MK, Winslow E, Bruening MM. An individually tailored family-centered intervention for pediatric obesity in primary care: study protocol of a randomized type II hybrid effectiveness-implementation trial (Raising Healthy Children study). Implement Sci. 2018 Jan 15;13(1):11. doi: 10.1186/s13012-017-0697-2.

Reference Type DERIVED
PMID: 29334983 (View on PubMed)

Other Identifiers

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1U18DP006255-01

Identifier Type: NIH

Identifier Source: org_study_id

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