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临床试验/NCT02697565
NCT02697565已完成不适用

Healthy Caregivers-Healthy Children (HC2) Phase II: Integrating Culturally Sensitive Childhood Obesity Prevention Strategies Into Policy

University of Miami2 个研究点 分布在 1 个国家目标入组 2,289 人开始时间: 2015年4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
2,289
试验地点
2
主要终点
Change in The Environment and Policy Assessment and Observation tool (EPAO) score

研究概览

简要总结

One in four U.S. children under the age of 5 years old are either overweight or obese with ethnic-minority children being disproportionately affected. Low-income preschool children, many from ethnic minority backgrounds, receive childcare in federal/state subsidized centers where daily meals are provided. Nationally, the Quality Rating and Improvement Systems (QRIS) organization is responsible for rating the quality of childcare centers. However, nutrition and physical activity policy standards have not been incorporated into QRIS childcare center policies. Therefore, the goal of this project is to address the 2014 AFRI program area priority of Childhood Obesity Prevention by building on the phase I "Healthy Caregivers, Healthy Children (HC2)" NRI/AFRI funded project (2010-2013), in partnership with the Miami Dade County Cooperative Extension team, to evaluate the program via randomized-controlled trial outcomes, and deliver an evidence-based effective childcare center-based program/toolkit. This project (phase II) will expand HC2 Phase I findings by transferring the evidence-based HC2 program/toolkit to QRIS childcare centers via a train-the-trainers (TTT) model. The following specific aims are proposed; (1) to evaluate the TTT model of delivery for the evidence-based HC2 toolkit's effectiveness versus an attention control on parent and teacher adoption of healthy lifestyle role modeling behaviors, and policy integration; (2) to evaluate the impact of a TTT delivery model versus an attention control on child body composition and short- and long-term behavioral health outcomes, and (3) to disseminate the HC2 early childhood obesity prevention toolkit TTT model within the QRIS early childhood network at the Miami Dade County-level.

详细描述

While all states are responsible for childcare licensing standards, 26 states serving over 1 million preschool-age children currently implement QRIS. In MDC, QRIS-affiliated childcare facilities (collectively called Quality Counts or QC centers from this point forward) provide care to 1/3 of MDC's preschool-age children (80% are ethnic minorities) in 417 centers. At this time there are no nutrition policies included in the QRIS standards for childcare centers. Therefore, in light of the current childhood obesity epidemic, this project will address a major gap in knowledge and the disparities in access to healthy food consumption in the childcare center setting through HC2 implementation.

This study builds on previously funded work and will maximize the initial 3-year (2010-2013) investment the USDA made in phase I of the project to test effective obesity prevention strategies in the early childhood setting utilizing both educators and parents as nutritional gatekeeper, healthy lifestyle role models for 2-to-5 year-old children. The goal of this proposed project (phase II) is to expand the phase I evidence-based HC2 findings by giving ownership of the program/toolkit to the childcare centers via a train-the-trainers model and by implementing nutrition and physical activity standards into the Quality Rating Improvement System.

The proposed integrated project is responsive to the USDA's National Institute of Food and Agriculture (formerly CSREES) functions by addressing all three areas of the agricultural knowledge system, including (1) a scientifically-based and rigorous Research design that assesses obesity prevention efforts with young children in a novel setting of childcare facilities; (2) the development of an Educational tool kit to improve training and capacity of teachers and parents/families. Extension and capacity building will be enhanced through HC2 toolkits delivered to the centers and train-the-trainer program manuals for use throughout the QRIS network and in cooperation with Florida FNP. Finally, by incorporating HC2 practices into permanent QRIS policy, centers can sustain the project's benefits for future children, teachers, and families. Additionally, the investigators will collaborate with two community nutritionists to provide services to a large number of childcare centers in the county therefore, extending project materials. Lastly, the toolkit will sustain education and extension functions beyond the life of the project by giving ownership of HC2 to the childcare centers.

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
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • QC centers must meet the following criteria to be included: (1) have > 30 children ages 2-5 enrolled; (2) Serve low income families; (3) be a part of the USDA food program and Supplemental Nutrition Assistance Program (SNAP) eligible; (3) Reflect the ethnic diversity of the MDC Public School System (63 percent Hispanic, 19 percent African American, 18 percent white); and (4) Center directors agree to participate and sign a letter of commitment (see Documents of Collaboration).

排除标准

  • Centers with a high prevalence of special needs children.

结局指标

主要结局

Change in The Environment and Policy Assessment and Observation tool (EPAO) score

时间窗: 3 years

The EPAO will examine childcare center environmental changes. The EPAO will assess the level of implementation of the snack, screen time, physical activity, and beverage policies through direct observation of diet and physical activity. Child health behaviors and parent and teacher health behaviors will also be measured.

次要结局

  • Observed pre-post maintenance on Child's Body Mass Index (BMI)(2 years)
  • Change of caregiver role modeling behavior(2 years)

研究者

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

Ruby Natale

Associate Professor of Clinical Pediatrics

University of Miami

研究点 (2)

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