Clinical TrialNCT04469816

AFRI Childhood Obesity Prevention Challenge Area

A study testing Family Check-Up 4 Health and Services as Usual in people with Clinical Trial, run by Arizona State University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 to 5 yearsHealthy volunteers can take part
Conditions the study is for: Clinical Trial
What is being tested?: Family Check-Up 4 Health and Services as Usual
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 217 participants
Where: 4 sitesUnited States
Study dates: 17 May 2017to 31 Jan 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 5 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Clinical Trial
Being tested: Family Check-Up 4 Health, Services as Usual
Keywords: Hybrid design, Implementation, Effectiveness, Parent Training, Cost-Effectiveness, Primary Care, Integrated Behavioral Health, Family-Based Prevention, Family Check-Up 4 Health, Fidelity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Family Check-Up 4 HealthBehavioural
Also called FCU4Health
A parent-training intervention to improve child health, school readiness and manage obesity.
Services as UsualOther
Services/Treatment as usual.

Study groups in NCT04469816
Study group	Role	What they receive
Behavioral: Family Check-Up 4 Health	Experimental	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. Receives: Behavioral: Family Check-Up 4 Health
Control-Services as Usual	Experimental	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. Receives: Other: Services as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in the Family Health Behavior Scale
Family Mealtime Routines. Minimum Value: 0. Maximum Value: 20. Where higher scores mean a better outcome.
Measured: 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
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.
Measured: 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
Child Eating Behaviors. Minimum Value: 0. Maximum Value: 20. Where higher scores mean a worse outcome.
Measured: The investigators will examine trajectories of child eating behaviors over 3 annual assessments (baseline, 1-year, 2-year follow-up).

Secondary outcomes (16)

Strengths and Difficulties Questionnaire
Conduct Problems. Minimum Value: 0. Maximum Value: 2. Where higher scores mean a worse outcome.
Measured: The investigators will examine trajectories of child conduct problems over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Children's Behavior Questionnaire
Effortful Control. Minimum Value: 1. Maximum Value: 5. Where higher scores mean a better outcome.
Measured: The investigators will examine trajectories of child effortful control over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Strengths and Difficulties Questionnaire
Prosocial Behavior. Minimum Value: 0. Maximum Value: 2. Where higher scores mean a better outcome.
Measured: The investigators will examine trajectories of prosocial behavior over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Strengths and Difficulties Questionnaire
Emotional Problems. Minimum Value: 0. Maximum Value: 2. Where higher scores mean a worse outcome.
Measured: The investigators will examine trajectories of emotional problems over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Brief Infant Sleep Questionnaire
Sleep Routines. Minimum Value: 0. Maximum Value: 24. Where higher scores mean a better outcome.
Measured: The investigators will examine trajectories of child sleep routines over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Media Parenting Scale
Media Routines. Minimum Value: 0. Maximum Value: 24. Where higher scores mean a better outcome.
Measured: 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
Child Physical Activity Habits. Minimum Value: 0. Maximum Value: 24. Where higher scores mean a better outcome.
Measured: 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)
Parenting Warmth. Minimum Value: 1. Maximum Value: 25. Where higher scores mean a worse outcome.
Measured: 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)
Family Conflict. Minimum Value: 0. Maximum Value: 6. Where higher scores mean a worse outcome.
Measured: The investigators will examine trajectories of family conflict over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Child-parent relationship scale
Parent Child Conflict. Minimum Value: 1. Maximum Value: 25. Where higher scores mean a worse outcome.
Measured: 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
Depression. Minimum Value: 0. Maximum Value: 80. Where higher scores mean a worse outcome.
Measured: 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)
Parenting Stress. Minimum Value: 1. Maximum Value: 4. Where higher scores mean a worse outcome.
Measured: The investigators will examine trajectories of parenting stress over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Tool for Substance Use Screening
Parent Substance Use. Minimum Value: 0. Maximum Value: 1. Where higher scores mean a worse outcome.
Measured: 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)
Incentive and Encouragement. Minimum Value: 0. Maximum Value: 4. Where higher scores mean a better outcome.
Measured: 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)
Proactive Parenting. Minimum Value: 0. Maximum Value: 4. Where higher scores mean a better outcome.
Measured: 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)
Limit Setting. Minimum Value: 0. Maximum Value: 4. Where higher scores mean a better outcome.
Measured: The investigators will examine trajectories of parent limit setting over 3 annual assessments (baseline, 1-year, 2-year follow-up).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 May 201731 Jan 2024

First posted14 Jul 2020
Study start17 May 2017
Primary completion29 Jan 2024
Study completion31 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Clinical TrialStudies of the same condition, open and under way.
More trials run by Arizona State UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 217 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04469816
Sponsor's protocol ID: FP00008342
Status last verified: May 2025
First submitted: 26 Jun 2020
Last updated: 25 May 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Crnic KA, Greenberg MT. Minor parenting stresses with young children. Child Dev. 1990 Oct;61(5):1628-37. doi: 10.1111/j.1467-8624.1990.tb02889.x.
PubMed 2245752
McEachern AD, Dishion TJ, Weaver CM, Shaw DS, Wilson MN, Gardner F. Parenting Young Children (PARYC): Validation of a Self-Report Parenting Measure. J Child Fam Stud. 2012 Jun;21(3):498-511. doi: 10.1007/s10826-011-9503-y.
PubMed 22876108
Stormshak EA, DeGarmo D, Garbacz SA, McIntyre LL, Caruthers A. Using Motivational Interviewing to Improve Parenting Skills and Prevent Problem Behavior During the Transition to Kindergarten. Prev Sci. 2021 Aug;22(6):747-757. doi: 10.1007/s11121-020-01102-w.
PubMed 32036553
Berkel C, Smith JD, Bruening MM, Jordan N, Fu E, Mauricio AM, Grimm KJ, Winslow E, Ray K, Bourne A, Dishion TJ. The Family Check-Up 4 Health: Study protocol of a randomized type II hybrid effectiveness-implementation trial in integrated primary care (the healthy communities 4 healthy students study). Contemp Clin Trials. 2020 Sep;96:106088. doi: 10.1016/j.cct.2020.106088. Epub 2020 Jul 22.
PubMed 32707101

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Family Check-Up for Health: A Family-Centered Health Maintenance Approach to Improve Nutrition and Prevent Obesity in Early Childhood
ClinicalTrials.gov ID: NCT04469816
Acronym / sponsor ID: FP00008342
Conditions: Clinical Trial
Keywords: Hybrid design, Implementation, Effectiveness, Parent Training, Cost-Effectiveness, Primary Care, Integrated Behavioral Health, Family-Based Prevention
Study type: Interventional
Recruitment status: Completed
Enrolment: 217 participants (actual)
Lead sponsor: Arizona State UniversityUniversity, hospital or other
Collaborators: Northwestern University
Study start: 17 May 2017 (actual)
Primary completion: 29 Jan 2024 (actual)
Study completion: 31 Jan 2024 (actual)
First posted: 14 Jul 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Behavioral: Family Check-Up 4 Health	Experimental	Behavioral: Family Check-Up 4 HealthFamilies 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.
Control-Services as Usual	Experimental	Other: Services as UsualFamilies 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.

Who may qualify

Ages: 2 to 5 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Family Check-Up 4 HealthAlso: FCU4HealthA parent-training intervention to improve child health, school readiness and manage obesity.	Behavioural	Behavioral: Family Check-Up 4 Health
Services as UsualServices/Treatment as usual.	Other	Control-Services as Usual

Primary outcome

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.
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.
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.

16 secondary outcomes

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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
Background: PubMed 2245752Crnic KA, Greenberg MT. Minor parenting stresses with young children. Child Dev. 1990 Oct;61(5):1628-37. doi: 10.1111/j.1467-8624.1990.tb02889.x.
Background: PubMed 22876108McEachern AD, Dishion TJ, Weaver CM, Shaw DS, Wilson MN, Gardner F. Parenting Young Children (PARYC): Validation of a Self-Report Parenting Measure. J Child Fam Stud. 2012 Jun;21(3):498-511. doi: 10.1007/s10826-011-9503-y.
Background: PubMed 32036553Stormshak EA, DeGarmo D, Garbacz SA, McIntyre LL, Caruthers A. Using Motivational Interviewing to Improve Parenting Skills and Prevent Problem Behavior During the Transition to Kindergarten. Prev Sci. 2021 Aug;22(6):747-757. doi: 10.1007/s11121-020-01102-w.
Derived from this study: PubMed 32707101Berkel C, Smith JD, Bruening MM, Jordan N, Fu E, Mauricio AM, Grimm KJ, Winslow E, Ray K, Bourne A, Dishion TJ. The Family Check-Up 4 Health: Study protocol of a randomized type II hybrid effectiveness-implementation trial in integrated primary care (the healthy communities 4 healthy students study). Contemp Clin Trials. 2020 Sep;96:106088. doi: 10.1016/j.cct.2020.106088. Epub 2020 Jul 22.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cady Berkel, Ph.D. principal investigator

Arizona State University

Justin D. Smith, Ph.D. principal investigator

Northwestern University

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Family Check-Up 4 Health and Services as Usual in people with Clinical Trial, run by Arizona State University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04469816, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.