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临床试验/NCT04552678
NCT04552678已完成不适用

Healthy Bodies Project: Modifying Family and Preschool Environments to Prevent Obesity

Penn State University0 个研究点目标入组 2,480 人开始时间: 2015年8月1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
2,480
主要终点
Food Choices

研究概览

简要总结

The goal of this study is to evaluate components of a preschool-based intervention designed to (1) increase children's nutrition knowledge, (2) increase physical activity in childcare settings, (3) increase emotional, behavioral and eating-related regulation, and (4) provide guidance to parents/caregivers about appropriate parenting and child-feeding strategies that promote healthy eating behaviors, dietary patterns and physical activity in preschool-aged children. The long-term goal is to help children develop healthy habits that reduce risk for obesity.

详细描述

Findings from intervention studies designed to prevent obesity among preschool children are mixed. One approach to stemming the development of obesity in childhood is to alter children's choices and environments in ways that promote food literacy, acceptance of healthy foods, physical activity and self-regulation. Research on factors that influence the development of obesity in children has identified factors in children's environments that are potential targets for prevention programs. The goal of this study is to evaluate the efficacy of components designed for a preschool-based approach to preventing obesity in children. Using an innovative approach to optimizing behavioral interventions, the multiphase optimization strategy (MOST), we will examine the effects of a 28-week, randomized set of experiments designed to (1) increase children's nutrition knowledge, (2) increase physical activity in childcare settings, (3) increase emotional, behavioral and eating-related regulation, and (4) provide guidance to parents/caregivers about appropriate parenting and child-feeding strategies that promote healthy eating behaviors, dietary patterns and physical activity in preschool-aged children. Participants will include over 1300 predominantly low-income preschool children ages 3 to 5 years attending center-based childcare settings in Pennsylvania (~100 classrooms). The proposed study will provide information on the most efficacious components that produce measurable changes in children's nutrition knowledge and obesity-related behaviors. The results of this study will be used to inform the design of a randomized controlled trial to prevent obesity in children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Assessors who collect data from children are blind to study condition.

入排标准

年龄范围
3 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Children ages 3 to 5 years enrolled in full-day, center-based childcare programs
  • •Caregiver ≥ 18 years of age
  • •Caregiver responsible for providing meals for child at least half of the time
  • •Fluent in English (caregiver and child)

排除标准

  • •Developmental delays or disorders that affect learning, mobility and eating

研究组 & 干预措施

Healthy Eating, Active Play, Self-Regulation, Parent Education

Experimental

Classrooms receive all curricula (Food Literacy, Healthy Eating, Active Play, Self-Regulation Curriculum) and Parent Education

干预措施: Healthy Eating, Active Play, Self-Regulation, Parent Education (Behavioral)

Healthy Eating, Active Play, Self-Regulation

Experimental

Classrooms receive all curricula (Food Literacy, Healthy Eating, Active Play, Self-Regulation Curriculum), but no Parent Education

干预措施: Healthy Eating, Active Play, Self-Regulation (Behavioral)

Healthy Eating, Active Play, Parent Education

Experimental

Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Active Play Curriculum, and Parent Education

干预措施: Healthy Eating, Active Play, Parent Education (Behavioral)

Healthy Eating + Active Play

Experimental

Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Active Play Curriculum, but no Parent Education

干预措施: Healthy Eating + Active Play (Behavioral)

Healthy Eating, Self-Regulation, Parent Education

Experimental

Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Self-Regulation Curriculum, and Parent Education

干预措施: Healthy Eating, Self-Regulation, Parent Education (Behavioral)

Healthy Eating + Self-Regulation

Experimental

Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Self-Regulation Curriculum, but no Parent Education

干预措施: Healthy Eating + Self-Regulation (Behavioral)

Healthy Eating + Parent Education

Experimental

Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, and Parent Education

干预措施: Healthy Eating + Parent Education (Behavioral)

Healthy Eating Only

Experimental

Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, but no Parent Education

干预措施: Healthy Eating Only (Behavioral)

Active Play, Self-Regulation, Parent Education

Experimental

Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, the Self-Regulation Curriculum, and Parent Education

干预措施: Active Play, Self-Regulation, Parent Education (Behavioral)

Active Play + Self-Regulation

Experimental

Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, the Self-Regulation Curriculum, but no Parent Education

干预措施: Active Play + Self-Regulation (Behavioral)

Active Play + Parent Education

Experimental

Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, and Parent Education

干预措施: Active Play + Parent Education (Behavioral)

Active Play Only

Experimental

Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, but no Parent Education

干预措施: Active Play Only (Behavioral)

Self-Regulation + Parent Education

Experimental

Classrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, and Parent Education

干预措施: Self-Regulation + Parent Education (Behavioral)

Self-Regulation Only

Experimental

Classrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, but no Parent Education

干预措施: Self-Regulation Only (Behavioral)

Food Literacy + Parent Education

Experimental

Classrooms receive the core Food Literacy Curriculum, and parents are invited to complete web-based education modules.

干预措施: Food Literacy + Parent Education (Behavioral)

Food Literacy Only

Experimental

Classrooms only receive the core Food Literacy Curriculum, and no other intervention materials or parent education.

干预措施: Food Literacy Only (Behavioral)

结局指标

主要结局

Food Choices

时间窗: Change from baseline to post-assessment (5-6months) and follow-up (~9 months)

Children's choices between energy- vs. nutrient-dense foods for a hypothetical lunch using the Snack Selection Procedure

Child Body Mass Index (BMI)

时间窗: Change from baseline to post-assessment (5-6months) and follow-up (~9 months)

Absolute BMI, BMI z-score (BMIz), BMI percentile (BMIp) calculated from measured height and weight

Children's Behavioral Regulation - Observed

时间窗: Change from baseline to post-assessment (5-6months) and follow-up (~9 months)

Behavioral tasks that measure child inhibitory control: Walk a Line Slowly, Peg/Pencil Tapping Procedure and Choosing Dinky Toys. Assessor reports of children's emotions, attention, and behavior: Preschool Self-Regulation Assessor Report

Nutrition Knowledge

时间窗: Change from baseline to post-assessment (5-6months) and follow-up (~9 months)

Ability to identify energy- vs. nutrient-dense foods using the Food Knowledge Procedure

Physical and Sedentary Activity

时间窗: Change from Baseline to Mid-Intervention (~3 months), Post-Intervention (5-6 months) and follow-up (~9 months)

Children's engagement in sedentary and moderate-vigorous physical activity during the school day objectively measured via accelerometry.

Children's Behavioral Regulation - Parent- and Teacher-Report

时间窗: Change from baseline to post-assessment (5-6months)

Teacher reports of children's attentional focusing, impulsivity and inhibitory control: Child Behavior Questionnaire Parent reports of children's impulsivity and inhibitory control: Child Behavior Questionnaire

Children's Emotion Regulation - Parent- and Teacher-Report

时间窗: Change from baseline to post-assessment (5-6months)

Parent and Teacher reports of children's anger/frustration: Child Behavior Questionnaire

Children's Eating in the Absence of Hunger

时间窗: Change from baseline to post-assessment (5-6months)

Parent reported measure of children's eating in the absence of hunger due to negative emotions, fatigue/boredom, or external food cues.

次要结局

  • Children's Food Requests(Baseline, Post-Intervention (5-6 months))
  • Children's Appetitive Behaviors(Baseline, Post-Intervention (5-6 months))
  • Parental reports of children's requests for fruits, vegetables, whole grains and dairy(Baseline, Post-Intervention (5-6 months))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lori Francis

Associate Professor of Biobehavioral Health

Penn State University

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