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临床试验/NCT05486403
NCT05486403已完成不适用

The Appetite Toolbox: A Hybrid Type I Pilot Trial Testing the Effectiveness and Initial Implementation of a Programme Designed to Promote Children's Eating Regulation Skills in Preschool.

Institute for Human Development and Potential (IHDP), Singapore2 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2022年7月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
205
试验地点
2
主要终点
Child appetite awareness

研究概览

简要总结

This study uses a Hybrid research design to assess the effectiveness and implementation of a preschool-based programme - the Appetite Toolbox - delivered by Early Childhood Educators to promote children's appetite awareness and eating regulation skills. Children, their caregivers and classroom teachers will be recruited across 18 classrooms from preschool childcare centers. Preschool educators will deliver the Appetite Toolbox over a period of six weeks. Using a waitlist-control design we will measure changes in children's appetite awareness and eating regulation skills in school and describe implementation outcomes, such as fidelity, acceptability, and feasibility of the programme.

详细描述

The Appetite Toolbox is a programme developed for use in preschools and designed to promote children's appetite awareness and eating regulation skills through a series of books, classroom activities and mealtime routines developed with curriculum specialists and aligned to the Centre's core curriculum competencies (e.g. Language and Literacy, and Social and Emotional Development).

Using a Hybrid Type I cluster-controlled pilot design, the Appetite Toolbox for preschools study aims to:

i) Characterise the effectiveness of the Appetite Toolbox delivered over to increase children's awareness of appetite and eating regulation skills over a six-week period.

ii) Assess implementation of the Appetite Toolbox in preschool centers, with a focus on acceptability, appropriateness, fidelity, and feasibility of Appetite Toolbox as delivered by preschool educators.

The research team will also explore whether differences in home feeding practices and implementation factors moderated the effectiveness of the Appetite Toolbox in preschools.

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
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 3 years 0 months to 6 years 11 months.
  • English speaker (primary or secondary language)
  • Enrolled in the childcare Program of the participating school
  • Parent/Legal guardian/Caregiver:
  • Age 21 years and older
  • English speaker (primary or secondary language)
  • Age 21 years and older
  • English speaker (primary or secondary language)
  • Currently employed as teaching staff at a participating preschool

排除标准

  • Severe food allergy
  • Does not normally eat the school's meal and snack provisions
  • Non-English speaker (English is not primary or secondary language)
  • A medical condition affecting appetite and metabolism
  • Parent/Legal guardian/Caregiver:
  • Below 21 years old
  • A non-English speaker (English is not primary or secondary language)
  • Below 21 years old
  • A non-English speaker (English is not primary or secondary language)
  • Not employed as teaching staff at a participating preschool

结局指标

主要结局

Child appetite awareness

时间窗: Baseline and Post-intervention (~6 weeks)

Difference in accuracy in identifying changes in hunger and fullness pre- and post- meal for i) self (measured at lunch time), and ii) a fictional character described in a story. Ratings will be made on a custom 5-point picture rating scale ranging from "very hungry, my tummy is empty" (1) to "Very full, there is no room left in my tummy".

Child eating in the absence of hunger (EAH)

时间窗: Baseline and Post-intervention (~6 weeks)

Differences in the tendency for children to 'eat in the absence of hunger' (EAH) pre- and post-intervention. EAH is measured as the total calories consumed from a snack immediately presented within 10 minutes after consuming lunch, where more calories consumed confers greater EAH.

次要结局

  • Implementation outcomes (qualitative)(Post-intervention (~6 weeks))
  • Appetite Toolbox Fidelity(During the intervention (~ week 1, 2, 3, 4, 5, and 6 of the Appetite Toolbox programme))
  • Implementation outcomes (quantitative)(Baseline and Post-intervention (~6 weeks))

研究者

发起方
Institute for Human Development and Potential (IHDP), Singapore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Keri McCrickerd

Research Scientist

Institute for Human Development and Potential (IHDP), Singapore

研究点 (2)

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