AFRI Childhood Obesity Prevention Challenge Area

Sponsor
Arizona State University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04469816
Collaborator
Northwestern University (Other)
200
4
2
59.4
50
0.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Family Check-Up 4 Health
  • Other: Services as Usual
N/A

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
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Family Check-Up for Health: A Family-Centered Health Maintenance Approach to Improve Nutrition and Prevent Obesity in Early Childhood
Actual Study Start Date :
May 17, 2017
Anticipated Primary Completion Date :
Mar 30, 2022
Anticipated Study Completion Date :
Apr 30, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

    Outcome Measures

    Primary Outcome Measures

    1. Changes in the Family Health Behavior Scale [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.

    2. Changes in the HABITS questionnaire [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.

    3. Changes in the Family Health Behavior Scale [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.

    Secondary Outcome Measures

    1. Strengths and Difficulties Questionnaire [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.

    2. Children's Behavior Questionnaire [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.

    3. Strengths and Difficulties Questionnaire [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.

    4. Strengths and Difficulties Questionnaire [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.

    5. Brief Infant Sleep Questionnaire [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.

    6. Media Parenting Scale [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.

    7. 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 Physical Activity Habits. Minimum Value: 0. Maximum Value: 24. Where higher scores mean a better outcome.

    8. Trajectories of Community Action for Successful Youth Measure (See Reference Section for citing of title) [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.

    9. 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).]

      Family Conflict. Minimum Value: 0. Maximum Value: 6. Where higher scores mean a worse outcome.

    10. Child-parent relationship scale [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.

    11. 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).]

      Depression. Minimum Value: 0. Maximum Value: 80. Where higher scores mean a worse outcome.

    12. 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).]

      Parenting Stress. Minimum Value: 1. Maximum Value: 4. Where higher scores mean a worse outcome.

    13. 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).]

      Parent Substance Use. Minimum Value: 0. Maximum Value: 1. Where higher scores mean a worse outcome.

    14. Trajectories of Parenting Young Children (See Reference Section for citing of title) [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.

    15. Trajectories of Parenting Young Children (See Reference Section for citing of title) [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.

    16. 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).]

      Limit Setting. Minimum Value: 0. Maximum Value: 4. Where higher scores mean a better outcome.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 5 Years
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Avondale School District Avondale Arizona United States 852323
    2 Bayless Integrated Healthcare Avondale Arizona United States 85323
    3 Care1st Avondale Resource and Housing Avondale Arizona United States 85323
    4 Arizona State University Tempe Arizona United States 85281

    Sponsors and Collaborators

    • Arizona State University
    • Northwestern University

    Investigators

    • Principal Investigator: Cady Berkel, Ph.D., Arizona State University
    • Principal Investigator: Justin D. Smith, Ph.D., Northwestern University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Arizona State University
    ClinicalTrials.gov Identifier:
    NCT04469816
    Other Study ID Numbers:
    • FP00008342
    First Posted:
    Jul 14, 2020
    Last Update Posted:
    Aug 4, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Arizona State University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 4, 2021