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临床试验/NCT01924130
NCT01924130已完成不适用

Increasing Breakfast Consumption and Decreasing Childhood Obesity Among Low-income, Ethnically Diverse Youth.

Temple University2 个研究点 分布在 1 个国家目标入组 2,000 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
2,000
试验地点
2
主要终点
Breakfast Consumption habits

研究概览

简要总结

The purpose of this study is to develop and evaluate the effects of a school breakfast policy initiative (SBPI) on the incidence of overweight and obesity as well as breakfast patterns (both inside and outside of school) among 4th-6th grade children. The study integrates research, education and extension to promote healthy breakfast consumption among low-income children in urban schools and will leverage ongoing SNAP-Ed and the School Breakfast Program efforts.

详细描述

Policy makers have promoted school breakfast participation as a tool to help prevent childhood obesity. No randomized controlled trials have examined the effects of a school breakfast feeding program on obesity. We propose to develop and evaluate a School Breakfast Policy Initiative (SBPI) that combines classroom feeding, in-school nutrition education, social marketing and parent outreach. Specifically, we will promote the benefits of a healthy breakfast at school or home and deter buying "breakfast" at corner stores where purchases are high in energy, solid fats and added sugars. This intervention will be evaluated in the "real world" of urban schools that make frequent use of the SNAP-Ed and the School Breakfast Program. The specific aims are:

  1. To develop the SBPI intervention within the context of SNAP Ed and the National School Breakfast Program in the School District of Philadelphia.
  2. To conduct a pilot feasibility study among 4 schools (2 intervention and 2 control) to assess feasibility and acceptability.
  3. To compare participants in the intervention (n=8) and comparison schools (n=8) on the incidence of overweight and obesity. We predict that intervention schools, compared to the comparison schools, will have a significantly lower incidence rate of overweight and obesity over a 2 y period.
  4. To compare participants in the intervention (n=8) and comparison schools (n=8) on eating one breakfast. We predict that intervention schools, compared to the comparison schools, will have significantly greater percentage of children eating one breakfast per day over a 2 y period.

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
7 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 4th-8th grade Philadelphia public school students.

排除标准

  • 未提供

研究组 & 干预措施

One Healthy Breakfast Program

Experimental

Classroom feeding, nutrition education lessons, social marketing, and parent outreach.

干预措施: Nutrition education lessons (Behavioral)

Control

No Intervention

Only receive assessments.

One Healthy Breakfast Program

Experimental

Classroom feeding, nutrition education lessons, social marketing, and parent outreach.

干预措施: Classroom feeding (Other)

One Healthy Breakfast Program

Experimental

Classroom feeding, nutrition education lessons, social marketing, and parent outreach.

干预措施: Social Marketing (Behavioral)

One Healthy Breakfast Program

Experimental

Classroom feeding, nutrition education lessons, social marketing, and parent outreach.

干预措施: Parent outreach (Behavioral)

结局指标

主要结局

Breakfast Consumption habits

时间窗: Pilot Study: baseline (September-October 2012), 8-9 month follow up (May 2014). Main Trial: baseline (September-December 2013), 16 month follow up (January-March 2015), 32 month follow up (April-June 2016)

Measured using a breakfast intake questionnaire.

Hunger

时间窗: Pilot Study: baseline (September-October 2012), 8-9 month follow up (May 2014). Main Trial: baseline (September-December 2013), 16 month follow up (January-March 2015), 32 month follow up (April-June 2016)

Measured using a hunger scale questionnaire.

School meal participation rates

时间窗: Every month for 34 months (September 2013-June 2016)

Body Mass Index

时间窗: Pilot Study: baseline (September-October 2012), 8-9 month follow up (May 2014). Main Trial: baseline (September-December 2013), 16 month follow up (January-March 2015), 32 month follow up (April-June 2016)

BMI is calculated using students' height and weight measurements.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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