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临床试验/NCT02043626
NCT02043626已完成不适用

School Wellness Policy: RCT to Implement & Evaluate Impact on Childhood Obesity

Yale University2 个研究点 分布在 1 个国家目标入组 796 人开始时间: 2011年8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
796
试验地点
2
主要终点
Change in body mass index (BMI).

研究概览

简要总结

Our long-term objective is to reduce the rates and risk of childhood obesity via school-based nutrition and physical activity policies. Using a randomized design, we propose to monitor and evaluate how Connecticut's first-ranked District Wellness Policy, in the New Haven Public School district, is implemented and determine its impact on children's obesogenic behaviors, weight outcomes, and school performance. This study is designed to significantly advance empirical research on school wellness policies and to provide important evidence to guide future interventions in schools and communities - translating science to improved health of the public.

详细描述

Consistent with NIH priorities, our long-term objective is to reduce the rates and risk of childhood obesity via school-based nutrition and physical activity policies. We propose to monitor and evaluate how Connecticut's first-ranked School Wellness Policy, in the New Haven Public School district, is implemented and determine its impact on children's obesogenic behaviors, weight outcomes, and school performance. We will evaluate a strategy of implementation at 12 targeted schools using a randomized design. Focusing on targeted schools will enable a more rigorous evaluation of School Wellness Policy implementation, barriers/facilitators, and ultimately the behavioral and health impacts of school-based policies on childhood obesity. We propose a multi-level assessment of factors that may influence childhood obesity using the Ecological Model as a guiding framework.

Thus we propose a multi-sectoral, multi-level approach, focused on children, families, schools, and community. This ambitious project is possible because of the expertise and strong collaborative partnerships between The New Haven Public Schools and two Yale University research centers: The Rudd Center for Food Policy and Obesity and CARE: Community Alliance for Research and Engagement. Our partnership builds on Principles and Guidelines for Community-University Research Partnerships developed by a 12-member committee of community and university leaders and endorsed by Yale University and community partners in 2009.

This study is designed to significantly advance empirical research on school wellness policies: focused on implementation and measurable impact on student health. No matter how well written, a school wellness policy must be effectively implemented to achieve its potential impact. Further, students within schools represent only two components of a larger socio-ecological system that influences eating behavior, physical activity, and weight status. The federal mandate for school wellness policies requires districts to address many aspects of the school environment (e.g., nutrition education, nutrition standards for foods sold, and opportunities for physical activity). To maximize improvements, this type of multi-component policy is needed. However, this complexity makes it difficult to evaluate policy impact and draw conclusions about the causal relationships between specific policies and student health. With our team's unique strengths and these challenges in mind, we designed this research study with the following Specific Aims:

  1. Track and evaluate a strategy of targeted implementation of a School Wellness Policy.
  2. Identify factors that facilitate or impede implementation of The School Wellness Policy, including neighborhood, school, and student determinants; and
  3. Evaluate the impact of implementation of The School Wellness Policy on obesogenic behaviors and health outcomes as well as school performance.

We will collaborate with the District to implement a subset of nutrition and physical activity policies in 12 schools using a randomized 2 x 2 research design. This will permit comparison of the potential unique and synergistic effects of these nutrition and physical activity policies on student behaviors and related health outcomes. We will follow a cohort of 5th grade students (N≈700) annually for four years to assess potential changes to student eating behaviors, physical activity levels, and BMI. We use a multi-method approach to collect data and examine predictors of these outcomes from across levels of the socio-ecological framework: student variables, family characteristics, school policies, and neighborhood features.

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
None

入排标准

年龄范围
9 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Student of the New Haven School District--State of Connecticut
  • Enrolled in 12 eligible schools participating in study
  • Child between the ages of 9 and 14 or in grades 5-8 as of the fall of 2011
  • Primary Language of communication is English

排除标准

  • Not enrolled in one of 12 participating schools
  • Not in target grade (5-8) as of the fall 2011

结局指标

主要结局

Change in body mass index (BMI).

时间窗: Baseline through Follow-up: Grades 5-6-7-8

Body weight and height to calculate BMI annually from baseline (grade 5) through follow-up (grade 8)

次要结局

  • Change in level of physical activity.(Baseline through Follow-up: Grades 5-6-7-8)
  • Mental Health(Baseline through Follow-up: Grades 5-6-7-8)
  • Change in student nutritional habits (eating behaviors).(Baseline through Follow-up: Grades 5-6-7-8)
  • Standardized test scores(Baseline through Follow-up: Grades 5-6-7-8)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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