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临床试验/NCT03432715
NCT03432715已完成不适用

Approaches to Enhancing Wellness Policy Implementation in Schools to Promote Healthy Behaviors and Prevent Obesity

University of Maryland, Baltimore2 个研究点 分布在 1 个国家目标入组 2,773 人开始时间: 2017年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,773
试验地点
2
主要终点
Overweight/obesity

研究概览

简要总结

The Wellness Champions for Change (WCC) study aims to reduce pediatric obesity among students who attend schools in Maryland by training teacher and student-led wellness teams to increase opportunities for physical activity and healthy eating at school.

The study uses a cluster randomized design to allocate 6 schools (3 elementary, 3 middle) in 5 school systems to one of 3 arms: "A" (teacher and student training), "B" (teacher training only), and "C") (delayed teacher training/control). Approximately 36 3rd/6th graders and their caregivers ("evaluation cohort"), 15 4th/7th graders ("student leaders"), and 20 teachers from each school will be recruited in the spring before the intervention. All schools will identify a teacher "Wellness Champion" who will coordinate intervention activities. In "A" and "B" schools, wellness champions will attend a training to learn how to build a wellness team and create more opportunities for students to make healthy choices. In "A" schools, student leaders ("Student Wellness Champions") will meet weekly during lunch with a health educator to receive training as peer leaders and help the Wellness Champion with wellness initiatives. Student leaders in "B" and "C" schools will receive a monthly general Adolescent Health Curriculum. To assess the impact of the teacher and student-led interventions, the evaluation cohort will be followed for 2.5 years, with measures including: anthropometry (height/weight), 7-day accelerometry (physical activity), and validated questionnaires to assess healthy eating. Student leaders will be followed for 1.5 years to assess the impact of their participation, with measures including: anthropometry, 7-day accelerometry, validated questionnaires to assess healthy eating, and validated questionnaires and focus groups to assess leadership/advocacy skills. Teachers will complete validated questionnaires to investigate their perceptions of the school environment, classroom practices, and role modeling skills. Prior to data collection and analysis, participants will be assigned an identification number, and all documents linking participant information to identification numbers will be locked/ password-protected.

详细描述

The long-term goal of this project is to create health promoting school environments that support healthy growth and development of children in order to prevent obesity. The approach for creating health promoting school environments involves the school-level implementation of existing Local Wellness Policies (LWPs). Implementation science suggests that policy implementation may occur through diffusion ("letting it happen"), dissemination ("helping it happen"), or implementation ("making it happen"). Since LWPs were initially mandated in 2006, most school systems have relied on a diffusion or dissemination approach to LWP implementation, leading to limited implementation on the school-level. We propose a school-level LWP implementation strategy ("making it happen") that relies on educating/training teachers and students to be wellness champions. Through this proposed study, the impact of a school-level intervention to enhance LWP implementation (WCC) and the added benefit of training students to be wellness champions (WCC-students, "WCC-S") on student-level outcomes [diet, physical activity (PA), and obesity] will be examined through a randomized controlled trial.

Objectives are presented at the student and student wellness champion level:

Student Objectives:

Aim 1: To determine the impact of a school-based intervention ("Wellness Champions for Change" (WCC)) to enhance implementation of LWPs, on health behaviors (diet and PA) and weight status of elementary and middle school students through a randomized controlled trial.

Hypothesis 1: WCC will have a positive impact on health behaviors of students, compared to control.

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
Single (Outcomes Assessor)

盲法说明

All data collectors are masked.

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

  • Student attends a school that the Wellness Champions for Change Study has selected for the intervention year
  • Student is enrolled in the correct grade during spring recruitment
  • Student has the ability to read and write in English
  • Student has the ability to complete grade level surveys independently
  • Student has a participant caregiver

排除标准

  • Student has a health problem that would interfere with participation in physical education classes
  • Student is enrolled in a special education class (Health Leaders/SWC only)
  • Another student in the same grade living in the same household or who shares the same primary caregiver is already enrolled in the study (Evaluation Cohort Only)

结局指标

主要结局

Overweight/obesity

时间窗: 5 years

BMI-for-age z-score (calculated based on measured height and weight; self-reported gender and date of birth)

In-school diet behaviors

时间窗: 5 years

Dietary screener (Patterns of Diet at School: PODS)

Minutes per day in Moderate-Vigorous Physical Activity

时间窗: 5 years

Accelerometry (Actical); placed on the ankle

次要结局

  • School environment specific to healthy eating and physical activity(5 years)

研究者

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

Erin Hager

Associate Professor

University of Maryland, Baltimore

研究点 (2)

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