跳至主要内容
临床试验/NCT03334669
NCT03334669终止不适用

Empowerment as a Mechanism for Change in Childhood Obesity Prevention

Boston College2 个研究点 分布在 1 个国家目标入组 4,999 人开始时间: 2017年10月1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
4,999
试验地点
2
主要终点
Modified change in BMI z-score

研究概览

简要总结

The Communities for Healthy Living (CHL) program is a family-focused intervention to promote healthy lifestyle behaviors including diet and physical activity among children (age 3-to 5-years) and their families, enrolled in Head Start.

详细描述

This evaluation will test the effectiveness of a family-focused intervention, Communities for Healthy Living (CHL), implemented through Head Start. Over 20% of preschool-aged children in the US experience overweight or obese. Because obesity prevention depends heavily on the adoption of healthy lifestyle behaviors early in life, preventive efforts offer a higher promise for success if they are family-centered. Effective family-centered interventions for obesity prevention in preschool-aged children, however, remain elusive. While a number of interventions have shown positive effects on child Body Mass Index (BMI), results are inconsistent and short term effects are not maintained. What is more, because families at greatest risk of childhood obesity - including low-income, single-parent, and ethnic minority families - are the most difficult to recruit and retain, results are often limited in their applicability to high risk populations.

In response, the researchers have partnered with Head Start to develop and test a new approach to family-centered childhood obesity prevention that addresses family engagement upfront. The CHL program will be refined and rigorously tested for efficacy in collaboration with Head Start programs in the greater Boston area, which collectively serve over 2000 low-income children each year. Building on a previous pilot study, the investigators will broaden the parent-centered Community Based Participatory Research approach and include Head Start staff in the decision making and implementation process, refine intervention components, and expand technical assistance protocols to support Head Start ownership of CHL while ensuring implementation fidelity. In addition, consistent with the overarching theoretical framework (Family Ecological Model), neighborhood-level socioeconomic, food and physical activity environments around family homes and examine their impact on intervention outcomes will be measured to inform future scale up efforts.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Modified change in BMI z-score

时间窗: Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2)

BMI of a child is expressed relative to the median BMI in units of ½ of the distance between 0 and +2 z- scores. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5703793/

Change in Child BMI-z score

时间窗: Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2) rather than 4 years as planned

Change in child BMI-z score

次要结局

  • Change in child physical activity(Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2) rather than 4 years as planned)
  • Change in child fruit and vegetable intake(Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2) rather than 4 years as planned)
  • Change in child sleep duration(Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2) rather than 4 years as planned)
  • Change in child screen-time(Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2) rather than 4 years as planned)
  • Summer weight gain(Summer weight gain was assessed over 3 summer periods using BMI data collected at the beginning and end of each academic year)
  • Change in child sugar-sweetened beverage intake(Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2) rather than 4 years as planned)

研究者

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

Kirsten

Donahue and DiFelice Professor of Social Work

Boston College

研究点 (2)

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