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Clinical Trials/NCT03013309
NCT03013309CompletedNot Applicable

An Individually Tailored, Family-Centered Intervention for Childhood Obesity: Connecting Services in Pediatric Primary Healthcare, the Home and the Community

Arizona State University6 sites in 1 country240 target enrollmentStarted: May 9, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
240
Locations
6
Primary Endpoint
BMI

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
6 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

BMI

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

BMI

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (6)

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