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Completed

NCT Number: NCT03013309

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

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.

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Key information

Conditions

Clinical Trial

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phoenix Children's Hospital, Phoenix, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Family Check-Up 4 Health

Behavioral

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

Other names: FCU4Health

Treatment as Usual

Other

Treatment as usual

Primary outcomes

  1. BMI

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

    BMI

Secondary outcomes

  1. Body Composition

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

    % Body fat

  2. EuroQol-5D-5Level-Youth (EQ-5D-5L-Y)

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

    Quality of life

  3. PedsQL

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

    Quality of life

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • Northwestern University
  • University of Southern California
  • University of Washington

Registry information

Official study title

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

Acronym: FCU4Health

Important dates

Study start
2017
Primary completion
2023
Study completion
2024
First posted
Jan 6, 2017
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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