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临床试验/NCT02216968
NCT02216968已完成不适用

Increasing Vegetable Intake in Children

Baylor College of Medicine2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2012年7月最近更新:
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
600
试验地点
2
主要终点
Vegetable Intake in Preschool Children

研究概览

简要总结

The purpose of this study is to test the feasibility of an innovative approach to increase the amount of vegetable's (V) intake consumed by preschool children who are predominately African-American (AA) and Hispanic-American (HA).

详细描述

The purpose of this study is to test the feasibility of an innovative approach to increase the amount of vegetable's (V) intake consumed by preschool children who are predominately African-American (AA) and Hispanic-American (HA).The primary endpoint will be changes in V consumption in high school children with the hypothesis that a puppet intervention will increase their V consumption by preschool children. To achieve the project goal, our specific aims (SA) are to: SA1: Successfully recruit 6 preschool (PS) centers and 168 AA and 168 HA children 3 to 5 y enrolled there. SA2: Conduct individual interviews for formative assessment of the PUPPET shows. SA3: Develop the manual of operation and intervention protocols SA4: Develop 4 videotaped theatre-based PUPPET shows that are developmentally and cognitively appropriate for use with 3- to 5-year-old AA and HA children SA5: Pilot-test the feasibility of the PUPPET intervention with 3 intervention and 3 control HS centers. SA6: Use the data collected in Aim 5 to estimate parameters required to conduct a group randomized trial for an evaluation of the efficacy of the intervention. The primary hypothesis (H1) to be tested is that children who receive the PUPPET intervention will demonstrate increased V consumption in HS compared to children in the control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
Single (Participant)

入排标准

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

入选标准

  • non-patient
  • African-american
  • Hispanic-american
  • 3 to 5 y olds

排除标准

  • pregnant woman
  • dietary restrictions
  • chronic disease
  • developmental disabilities
  • special education
  • does not read or write in spanish or english

研究组 & 干预措施

AA - Increase vegetable intake

Experimental

60 African-American (AA) preschool children will participate in the Intervention Group. 60 AA children will belong to the Control Group.

6-week Intervention: 120 AA and HA children will be shown the Puppet Shows and will be given a bag of ingredients to prepare the vegetable highlighted that week in the Puppet Show. The 6 week intervention includes a baseline assessment (1 week), followed by the intervention (4 weeks), and post assessment (1 week). The primary hypothesis to be tested is children who receive the PUPPET intervention with a parent/teacher component will demonstrate "increase vegetable intake in pre-school children".

干预措施: Increase vegetable intake in pre-school children (Behavioral)

HA - Increase vegetable intake

Experimental

60 Hispanic-American (HA) preschool children will participate in the Intervention Group. 60 HA children will belong to the Control Group.

6-week Intervention: 120 AA and HA children will be shown the Puppet Shows and will be given a bag of ingredients to prepare the vegetable highlighted that week in the Puppet Show. The 6 week intervention includes a baseline assessment (1 week), followed by the intervention (4 weeks), and post assessment (1 week). The primary hypothesis to be tested is children who receive the PUPPET intervention with a parent/teacher component will demonstrate "increase vegetable intake in pre-school children".

干预措施: Increase vegetable intake in pre-school children (Behavioral)

结局指标

主要结局

Vegetable Intake in Preschool Children

时间窗: 1 year 11 months

There will be 2 phases to program development: diagnostic and formative. The diagnostic phase will consist of 20 individual interviews with child-care providers and parents (½ AA, ½ HA) and 20 interviews with preschool children (½ AA, ½ HA).In addition the parents will be asked to complete the Cooking Confidence Questionnaire, the Barriers and Facilitators Questionnaire on Vegetables and a list of their child's favorite vegetables before coming to the interview. Implementation will include the showing of the 4 video-taped puppet shows to 10-12 children immediately prior to the lunch meal on 4 consecutive days. These children will be assessed at lunch using the digital diet estimation method.

次要结局

未报告次要终点

研究者

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

Theresa A Nicklas

Professor

Baylor College of Medicine

研究点 (2)

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