NCT03013309

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

May 9, 2017

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 5, 2024

Status Verified

August 1, 2024

Enrollment Period

6.6 years

First QC Date

January 4, 2017

Last Update Submit

August 2, 2024

Conditions

Clinical Trial

Keywords

HybridImplementationEffectivenessParent trainingFidelityCost-EffectivenessPrimary Care

Outcome Measures

Primary Outcomes (1)

  • BMI

    BMI

    The investigators will examine trajectories based on 4 assessments over one year

Secondary Outcomes (3)

  • Body Composition

    The investigators will examine trajectories based on 4 assessments over one year

  • EuroQol-5D-5Level-Youth (EQ-5D-5L-Y)

    The investigators will examine trajectories based on 4 assessments over one year

  • PedsQL

    The investigators will examine trajectories based on 4 assessments over one year

Study Arms (2)

Intervention

EXPERIMENTAL

Receives the Family Check-Up 4 Health

Behavioral: Family Check-Up 4 Health

Control

EXPERIMENTAL

Receives Treatment as Usual

Other: Treatment as usual

Interventions

Family Check-Up 4 HealthBEHAVIORAL

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

Also known as: FCU4Health
Intervention
Treatment as usualOTHER

Treatment as usual

Control

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Terros Health

Phoenix, Arizona, 85012, United States

Location

Valle del Sol

Phoenix, Arizona, 85014, United States

Location

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Related Publications (5)

  • 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.

    PMID: 37790171DERIVED

  • 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.

    PMID: 37277878DERIVED

  • 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.

    PMID: 34159507DERIVED

  • 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.

    PMID: 33715136DERIVED

  • 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.

    PMID: 29334983DERIVED

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Cady Berkel, Ph.D.

    Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 6, 2017

Study Start

May 9, 2017

Primary Completion

December 30, 2023

Study Completion

June 30, 2024

Last Updated

August 5, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(3)