AFRI Childhood Obesity Prevention Challenge Area

Clinical Trial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04469816
• Other study ID #: FP00008342
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 17, 2017
• Est. completion date: April 30, 2022

Study information

• Verified date: August 2021
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: April 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Trial
• Obesity

Intervention

Behavioral:
• Family Check-Up 4 Health
A parent-training intervention to improve child health, school readiness and manage obesity.

Other:
• Services as Usual
Services/Treatment as usual.

Locations

Country	Name	City	State
United States	Avondale School District	Avondale	Arizona
United States	Bayless Integrated Healthcare	Avondale	Arizona
United States	Care1st Avondale Resource and Housing	Avondale	Arizona
United States	Arizona State University	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Crnic KA, Greenberg MT. Minor parenting stresses with young children. Child Dev. 1990 Oct;61(5):1628-37. — View Citation

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. — View Citation

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. 2020 Feb 8. doi: 10.1007/s11121-020-01102-w. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Family Health Behavior Scale	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).
Primary	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.	The investigators will examine trajectories of child food and beverage choices over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Primary	Changes in the Family Health Behavior Scale	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	Strengths and Difficulties Questionnaire	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).
Secondary	Children's Behavior Questionnaire	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).
Secondary	Strengths and Difficulties Questionnaire	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).
Secondary	Strengths and Difficulties Questionnaire	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).
Secondary	Brief Infant Sleep Questionnaire	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).
Secondary	Media Parenting Scale	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).
Secondary	The Family Health Behavior Scale	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).
Secondary	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.	The investigators will examine trajectories of parenting warmth over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Secondary	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.	The investigators will examine trajectories of family conflict over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Secondary	Child-parent relationship scale	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).
Secondary	Center for Epidemiologic Studies Depression Scale	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).
Secondary	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.	The investigators will examine trajectories of parenting stress over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Secondary	Tool for Substance Use Screening	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).
Secondary	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.	The investigators will examine trajectories of incentive and encouragement over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Secondary	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.	The investigators will examine trajectories of proactive parenting over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Secondary	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.	The investigators will examine trajectories of parent limit setting over 3 annual assessments (baseline, 1-year, 2-year follow-up).