Clinical trial NCT03013309: Raising Healthy Children: A Hybrid Trial of the Family Check-Up 4 Health in Primary Care
Official title: An Individually Tailored, Family-Centered Intervention for Childhood Obesity: Connecting Services in Pediatric Primary Healthcare, the Home and the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Trial
Keywords: Hybrid
Implementation
Effectiveness
Parent training
Fidelity
Cost-Effectiveness
Primary Care
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: University of Washington
name: University of Southern California
First posted: 2017-01-06
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: BMI
timeFrame: The investigators will examine trajectories based on 4 assessments over one year
Secondary outcomes:
measure: Body Composition
timeFrame: The investigators will examine trajectories based on 4 assessments over one year
measure: EuroQol-5D-5Level-Youth (EQ-5D-5L-Y)
timeFrame: The investigators will examine trajectories based on 4 assessments over one year
measure: PedsQL
timeFrame: The investigators will examine trajectories based on 4 assessments over one year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Terros Health
state: Arizona
city: Phoenix
country: United States
facility: Valle del Sol
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
Study officials:
affiliation: Arizona State University
name: Cady Berkel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.