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临床试验/NCT02077387
NCT02077387已完成不适用

Promoting Child Inhibitory Control Skills Around Food

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
2
主要终点
Caloric intake in the Eating in the Absence of Hunger (EAH) paradigm

研究概览

简要总结

Today's environment provides many hedonic stimuli that promote consumption of unhealthy energy-dense snack foods. It is widely recognized that a systems approach is required to deal with this complex problem. However, individuals, particularly children, also need to develop the personal capacity to deal with tempting stimuli and inhibit responses to these energy-dense foods. Therefore in this proposal, we will focus on enhancing higher level executive functions, particularly inhibitory control, which is needed to counterbalance impulsive behavior and is crucial for growth and development. We have chosen to focus on developing inhibitory control in preschool-age children because executive functioning/inhibitory control and eating habits are developing at this time. Among preschool-age children, inhibitory control is fostered through social play-based curriculums and has been found to be related to greater school readiness and academic skills. Therefore, the goal of this proposal is to adapt a play-based curriculum, the Tools of the Mind program, to promote greater inhibitory control skills in preschool children and decrease consumption of energy-dense snack foods. In Phase I, we will develop and pilot a Child Inhibitory Control Play-based Program (CHIC Play) among children age 4- to 6-years old. We will adapt the learning tools used in the Tools of the Mind curriculum and employ naturalistic play scenarios, drawings (visual support), and games to teach children to inhibit their responses to energy-dense snack foods. Once developed, we will test the efficacy of CHIC Play in the preschool setting. Parent groups will also be conducted to support the adoption of these skills at home. The primary outcome of interest is caloric intake and age- and gender-adjusted percent of daily caloric intake as measured by the Eating in the Absence of Hunger (EAH) free access procedure and a snack time procedure. Inhibitory control skills will also be measured using executive functioning tasks. Feasibility and acceptability of this program will be determined from parent, child, and teacher surveys. The purpose of this study is to develop a new innovative method of decreasing energy-dense snack food consumption by promoting the development of inhibitory control or impulse control. If successful, this program has the potential to play a role in the treatment and prevention of childhood obesity.

研究设计

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

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • child age between 4 and 6 years
  • child BMI ≥5th %ile (Children below this BMI percentile may have an underlying biological mechanism that influences eating behaviors.)
  • active parental consent

排除标准

  • child with major psychological diagnosis, developmental delay, or other medical disorder that affects weight, eating behaviors, and cognition
  • food allergies to the foods used in the study
  • plans to leave the preschool within the timeframe of the study

结局指标

主要结局

Caloric intake in the Eating in the Absence of Hunger (EAH) paradigm

时间窗: week 4

Eating in the Absence of Hunger paradigm: Children in the full state will be presented with 8 snack foods and allowed to eat ad libitum for 10 minutes. Caloric intake and age- and gender-adjusted percent of daily caloric intake will be assessed.

次要结局

  • Executive functioning(week 4)

研究者

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

Kay Rhee

Assistant Professor of Pediatrics

University of California, San Diego

研究点 (2)

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Promoting Child Inhibitory Control Skills Around Food | 临床试验