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临床试验/NCT04469816
NCT04469816已完成不适用

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

Arizona State University4 个研究点 分布在 1 个国家目标入组 217 人开始时间: 2017年5月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
217
试验地点
4
主要终点
Changes in the Family Health Behavior Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Family Check-Up 4 Health (Behavioral)

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.

干预措施: Services as Usual (Other)

结局指标

主要结局

Changes in the Family Health Behavior Scale

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Media Parenting Scale(The investigators will examine trajectories of child media routines 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).)
  • 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).)
  • Children's Behavior Questionnaire(The investigators will examine trajectories of child effortful control 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).)
  • Strengths and Difficulties Questionnaire(The investigators will examine trajectories of child conduct problems over 3 annual assessments (baseline, 1-year, 2-year follow-up).)
  • Strengths and Difficulties Questionnaire(The investigators will examine trajectories of prosocial behavior 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 parenting warmth 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 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)(The investigators will examine trajectories of proactive parenting over 3 annual assessments (baseline, 1-year, 2-year follow-up).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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