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Clinical Trials/NCT03013309
NCT03013309
Completed
N/A

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

Arizona State University3 sites in 1 country240 target enrollmentMay 9, 2017
ConditionsClinical Trial

Overview

Phase
N/A
Intervention
Not specified
Conditions
Clinical Trial
Sponsor
Arizona State University
Enrollment
240
Locations
3
Primary Endpoint
BMI
Status
Completed
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
May 9, 2017
End Date
June 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Study Sites (3)

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