AFRI Childhood Obesity Prevention Challenge Area

May 21, 2025 updated by: Arizona State University

The Family Check-Up for Health: A Family-Centered Health Maintenance Approach to Improve Nutrition and Prevent Obesity in Early Childhood

This study is a hybrid type 2 effectiveness-implementation 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 age (2-5 years old) and randomized to receive the intervention, FCU4Health, or services as usual. All families will be assessed annually over three years.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The FCU4Health is an assessment-driven, Motivational Interviewing (MI) based, parent training program. Parents complete a comprehensive assessment, including questionnaire of the family environment, parenting skills, and child adjustment and health behaviors, and additional observation data. The FCU4Health coordinator reviews the assessment results with the parents, using MI strategies to engage families in making change to support child behavioral health, and to create tailored follow-up services which include parent training modules and referrals to additional support services in the community.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
217

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Avondale, Arizona, United States, 852323
        • Avondale School District
      • Avondale, Arizona, United States, 85323
        • Bayless Integrated Healthcare
      • Avondale, Arizona, United States, 85323
        • Care1st Avondale Resource and Housing
      • Tempe, Arizona, United States, 85281
        • Arizona State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participating caregiver who is at least 18 years of age and understands English and/or Spanish well enough to complete study assessment.

Exclusion Criteria:

  • Two exceptions: (1) Children with special needs that preclude engagement in a nutrition-based behavioral intervention (e.g., g-tube dependence) and (2) children who are in state custody.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Behavioral: Family Check-Up 4 Health
Families will receive the FCU4Health program 3 times annually in a health maintenance model. The FCU4Health coordinator reviews the assessment results with the parents, using motivational interviewing 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.
Behavioral: Family Check-Up 4 Health
A parent-training intervention to improve child health, school readiness and manage obesity.
Other Names:
  • FCU4Health
Experimental: Control-Services as Usual

Families will continue with their medical standard of care and referrals for services as appropriate from the healthcare staff in their respective FQHCs or primary healthcare clinics.

Families will receive brochures about the community programs to which families in the FCU4Health arm are referred.
Other: Services as Usual
Services/Treatment as usual.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in the Family Health Behavior Scale
Time Frame: The investigators will examine trajectories of family mealtime routines over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Family Mealtime Routines. Minimum Value: 0. Maximum Value: 20. Where higher scores mean a better outcome.
The investigators will examine trajectories of family mealtime routines over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Changes in the HABITS questionnaire
Time Frame: The investigators will examine trajectories of child food and beverage choices over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Child Food and Beverage Choices. Food Minimum Value: 0. Maximum Value: 24. Where higher food scores mean a better outcome and higher beverage scores mean a worse outcome.
The investigators will examine trajectories of child food and beverage choices over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Changes in the Family Health Behavior Scale
Time Frame: The investigators will examine trajectories of child eating behaviors over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Child Eating Behaviors. Minimum Value: 0. Maximum Value: 20. Where higher scores mean a worse outcome.
The investigators will examine trajectories of child eating behaviors over 3 annual assessments (baseline, 1-year, 2-year follow-up).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Strengths and Difficulties Questionnaire
Time Frame: The investigators will examine trajectories of child conduct problems over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Conduct Problems. Minimum Value: 0. Maximum Value: 2. Where higher scores mean a worse outcome.
The investigators will examine trajectories of child conduct problems over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Children's Behavior Questionnaire
Time Frame: The investigators will examine trajectories of child effortful control over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Effortful Control. Minimum Value: 1. Maximum Value: 5. Where higher scores mean a better outcome.
The investigators will examine trajectories of child effortful control over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Strengths and Difficulties Questionnaire
Time Frame: The investigators will examine trajectories of prosocial behavior over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Prosocial Behavior. Minimum Value: 0. Maximum Value: 2. Where higher scores mean a better outcome.
The investigators will examine trajectories of prosocial behavior over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Strengths and Difficulties Questionnaire
Time Frame: The investigators will examine trajectories of emotional problems over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Emotional Problems. Minimum Value: 0. Maximum Value: 2. Where higher scores mean a worse outcome.
The investigators will examine trajectories of emotional problems over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Brief Infant Sleep Questionnaire
Time Frame: The investigators will examine trajectories of child sleep routines over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Sleep Routines. Minimum Value: 0. Maximum Value: 24. Where higher scores mean a better outcome.
The investigators will examine trajectories of child sleep routines over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Media Parenting Scale
Time Frame: The investigators will examine trajectories of child media routines over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Media Routines. Minimum Value: 0. Maximum Value: 24. Where higher scores mean a better outcome.
The investigators will examine trajectories of child media routines over 3 annual assessments (baseline, 1-year, 2-year follow-up).
The Family Health Behavior Scale
Time Frame: The investigators will examine trajectories of child physical activity habits over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Child Physical Activity Habits. Minimum Value: 0. Maximum Value: 24. Where higher scores mean a better outcome.
The investigators will examine trajectories of child physical activity habits over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Trajectories of Community Action for Successful Youth Measure (See Reference Section for citing of title)
Time Frame: The investigators will examine trajectories of parenting warmth over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Parenting Warmth. Minimum Value: 1. Maximum Value: 25. Where higher scores mean a worse outcome.
The investigators will examine trajectories of parenting warmth over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Trajectories of Community Action for Successful Youth Measure (See Reference Section for citing of title)
Time Frame: The investigators will examine trajectories of family conflict over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Family Conflict. Minimum Value: 0. Maximum Value: 6. Where higher scores mean a worse outcome.
The investigators will examine trajectories of family conflict over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Child-parent relationship scale
Time Frame: The investigators will examine trajectories of parent child conflict over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Parent Child Conflict. Minimum Value: 1. Maximum Value: 25. Where higher scores mean a worse outcome.
The investigators will examine trajectories of parent child conflict over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Center for Epidemiologic Studies Depression Scale
Time Frame: The investigators will examine trajectories of parent depression over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Depression. Minimum Value: 0. Maximum Value: 80. Where higher scores mean a worse outcome.
The investigators will examine trajectories of parent depression over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Trajectories of Parenting Daily Hassles (See Reference Section for citing of title)
Time Frame: The investigators will examine trajectories of parenting stress over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Parenting Stress. Minimum Value: 1. Maximum Value: 4. Where higher scores mean a worse outcome.
The investigators will examine trajectories of parenting stress over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Tool for Substance Use Screening
Time Frame: The investigators will examine trajectories of parent substance use over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Parent Substance Use. Minimum Value: 0. Maximum Value: 1. Where higher scores mean a worse outcome.
The investigators will examine trajectories of parent substance use over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Trajectories of Parenting Young Children (See Reference Section for citing of title)
Time Frame: The investigators will examine trajectories of incentive and encouragement over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Incentive and Encouragement. Minimum Value: 0. Maximum Value: 4. Where higher scores mean a better outcome.
The investigators will examine trajectories of incentive and encouragement over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Trajectories of Parenting Young Children (See Reference Section for citing of title)
Time Frame: The investigators will examine trajectories of proactive parenting over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Proactive Parenting. Minimum Value: 0. Maximum Value: 4. Where higher scores mean a better outcome.
The investigators will examine trajectories of proactive parenting over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Trajectories of Parenting Young Children (See Reference Section for citing of title)
Time Frame: The investigators will examine trajectories of parent limit setting over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Limit Setting. Minimum Value: 0. Maximum Value: 4. Where higher scores mean a better outcome.
The investigators will examine trajectories of parent limit setting over 3 annual assessments (baseline, 1-year, 2-year follow-up).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arizona State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Northwestern University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Justin D. Smith, Ph.D., Northwestern University
  • Principal Investigator: Cady Berkel, Ph.D., Arizona State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FP00008342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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