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临床试验/NCT03111264
NCT03111264终止不适用

Building Blocks for Healthy Preschoolers: Child Care and Family Models

University of Maryland, Baltimore2 个研究点 分布在 1 个国家目标入组 1,943 人开始时间: 2016年6月17日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1,943
试验地点
2
主要终点
Change of BMI Z-score for preschoolers

研究概览

简要总结

Pediatric obesity, a defining health problem of the century, leads to long-term health disparities. This application evaluates strategies to prevent health disparities early in life by developing environmental wellness-related interventions focused on child-care center staff and families.

Childcare centers provide an excellent opportunity to build healthy dietary and physical activity lifestyle habits and avoid the rapid weight gain that leads to health disparities. Building on a statewide survey among childcare centers and a pilot evaluation of an environmental intervention, this 3-cell randomized trial evaluates the impact of a staff-led wellness intervention and a staff-led and family-focused intervention, against a control condition.

详细描述

The intervention trial will be conducted in 48-55 childcare centers throughout Maryland, enrolling 864 children age 30-54 months from childcare centers serving low-income families. The aims are:

  1. to examine the impact of the wellness intervention individually and combined with the family intervention versus control on BMI z-score, food preferences and knowledge, and physical activity among children
  2. to examine the sustainability of the interventions
  3. to examine whether changes in outcomes measures for children's BMI z-score, gross motor skills, food preferences and knowledge, and physical activity are mediated by changes in the childcare staff wellness-related attitudes and behaviors and/or parent wellness-related attitudes and behaviors (exploratory).

Findings from the trial will inform programs and policies in childcare centers to prevent obesity and reduce disparities, and will be disseminated locally, regionally, and nationally through conferences, information briefs, social media, and peer-reviewed journal articles. The overall objective is to promote statewide strategies that reduce pediatric obesity and the long-term health disparities.

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 (Participant)

盲法说明

One third of recruited childcare centers (control) will not receive any intervention (CHAMP nor CHAMP+). The remaining two-thirds of the recruited centers will receive the CHAMP intervention, of those, one third will also receive the CHAMP+ parenting intervention.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Preschooler 30-54 months
  • Caregiver and childcare staff must be at least 18 years old
  • Childcare center staff members willing to participate
  • Licensed childcare centers serving low-income communities
  • Children attending participating childcare centers (at least 3 days per week)

排除标准

  • Caregivers and staff who do not speak or read English
  • Childcare staff and preschoolers with health problems that would interfere with participation in physical activities

结局指标

主要结局

Change of BMI Z-score for preschoolers

时间窗: Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up

Measured weight and height for the preschoolers, calculated as age and gender-specific BMI Z-score

次要结局

  • Change of Physical Activity for preschoolers and childcare center staff(Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up)
  • Change in Gross Motor Skills(Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up)
  • Change in Preschoolers to try new foods(Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up)

研究者

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

Maureen Black

Professor

University of Maryland, Baltimore

研究点 (2)

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