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Clinical Trials/NCT04469816
NCT04469816CompletedNot Applicable

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

Arizona State University8 sites in 1 country217 target enrollmentStarted: May 17, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
217
Locations
8
Primary Endpoint
Changes in the Family Health Behavior Scale

Study Overview

Brief 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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
2 Years to 5 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Children's Behavior Questionnaire(The investigators will examine trajectories of child effortful control over 3 annual assessments (baseline, 1-year, 2-year follow-up).)
  • Center for Epidemiologic Studies Depression Scale(The investigators will examine trajectories of parent depression over 3 annual assessments (baseline, 1-year, 2-year follow-up).)
  • Trajectories of Parenting Young Children (See Reference Section for citing of title)(The investigators will examine trajectories of parent limit setting over 3 annual assessments (baseline, 1-year, 2-year follow-up).)
  • Brief Infant Sleep Questionnaire(The investigators will examine trajectories of child sleep routines over 3 annual assessments (baseline, 1-year, 2-year follow-up).)
  • Tool for Substance Use Screening(The investigators will examine trajectories of parent substance use over 3 annual assessments (baseline, 1-year, 2-year follow-up).)
  • Strengths and Difficulties Questionnaire(The investigators will examine trajectories of emotional problems over 3 annual assessments (baseline, 1-year, 2-year follow-up).)
  • The Family Health Behavior Scale(The investigators will examine trajectories of child physical activity habits over 3 annual assessments (baseline, 1-year, 2-year follow-up).)
  • Child-parent relationship scale(The investigators will examine trajectories of parent child conflict over 3 annual assessments (baseline, 1-year, 2-year follow-up).)
  • Media Parenting Scale(The investigators will examine trajectories of child media routines 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)(The investigators will examine trajectories of family conflict over 3 annual assessments (baseline, 1-year, 2-year follow-up).)
  • Trajectories of Parenting Daily Hassles (See Reference Section for citing of title)(The investigators will examine trajectories of parenting stress over 3 annual assessments (baseline, 1-year, 2-year follow-up).)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (8)

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