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临床试验/NCT03575884
NCT03575884已完成不适用

Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers: A RCT

Seattle Children's Hospital6 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2018年9月18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
201
试验地点
6
主要终点
Screen Time

研究概览

简要总结

Childhood obesity and metabolic risk are at record high levels in the US, and Latino children are at very high risk. This project will test an intervention called Fit 5 Kids, designed for Latino preschoolers to decrease their screen time in order to promote physical activity and healthy eating, and to prevent obesity. Ultimately, this line of research has the potential to provide an effective program to reduce risk of obesity for Latinos in the Head Start program and other preschool-based settings.

详细描述

Screen time is a major risk factor for childhood obesity and inadequate physical activity, both of which are determinants of type 2 diabetes (T2D), cardiovascular disease, and multiple cancers. Latinos are the largest and fastest growing minority in the US. Because US Latino children have more screen time and higher rates of obesity than their non-Latino White peers, interventions to reduce screen time adapted for Latino preschoolers are necessary to reduce health inequities related to obesity and T2D in the US. However, a systematic review reported no successful screen time reduction interventions among Latino preschoolers.

The investigative team's pilot study tested the culturally adapted Fit 5 Kids screen time reduction curriculum among Latino preschoolers in Head Start. This short term cluster randomized controlled trial (RCT) is the only successful screen time reduction program for Latino preschoolers, having significantly reduced screen time by over 25 minutes/day. The investigative team's culturally adapted, multi-level intervention consists of lessons taught by study staff directly to preschoolers during Head Start, a weekly parent newsletter, and parenting tips via text messages several times/week. The investigative team will use a social ecological model and consider multiple levels of influences for analyses: (1) individual-level influences, e.g., acculturation and social cognitive theory, (2) families, e.g., screen time parenting practices, (3) schools, and (4) macro-environmental influences, e.g., neighborhood disorder. Building on this pilot work, the investigative team proposes a long term, efficacy, cluster RCT of the culturally adapted Fit 5 Kids among Latino preschoolers in Head Start from three US settings: Seattle, Houston, and the Central Valley of Washington State. Among 280 Latino 3-5 year olds at 20 Head Start centers, the investigative team's Specific Aims (SA) and Hypotheses (H) include:

SA1) To conduct a cluster RCT of the culturally adapted Fit 5 Kids curriculum to evaluate its efficacy in reducing screen time and excessive weight gain over a school year (8-months) H1) Fit 5 Kids will decrease children's screen time, BMI z-scores and dietary energy intake, and increase fruit/vegetable intake, skin carotenoids, and moderate/vigorous physical activity (MVPA) compared to controls

SA2) To examine mediators and moderators associated with reducing Latino preschoolers' screen time H2) Parents' outcome expectations, self-efficacy, and TV parenting practices will mediate the relationship between Fit 5 Kids and changes to preschoolers' screen time H3) Depressive symptoms, stress, and social support will moderate changes to preschoolers' screen time

The proposed Fit 5 Kids RCT will confirm the pilot's promising results, and the larger sample will allow for mediation analyses to better understand mechanisms. This research will provide justification for a future community effectiveness trial with implementation by Head Start teachers, and the eventual widespread implementation of Fit 5 Kids in Head Start centers nationally.

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

入选标准

  • Latino children, 3-5 years old, enrolled from 1 of the 20 Head Start Centers.
  • Preschoolers do not require a minimum amount of screen time or devices in their household to enroll in the study, because it is preventive and population-based.
  • Parents must be able to complete forms in English or Spanish.

排除标准

  • Any preschooler that is underweight or under medical supervision to gain weight.
  • Only one preschooler per family may be enrolled, to avoid clustering of variables by family.
  • Preschoolers may only enroll once in the study.
  • Children <3 years and >5 years of age.
  • Children whose parents do not identify them as Latino or Hispanic.

结局指标

主要结局

Screen Time

时间窗: Week 1-2, Week 11-12, and Week 34-36

Screen Time Pre-intervention vs Post-intervention, measured by Screen Time Diary (7-day)

次要结局

  • BMI Z-score(Week 1-2, Week 11-12, and Week 34-36)
  • Dietary Intake by Food Screener Data in Grams(Week 1-2, Week 11-12, and Week 34-36)
  • Fruit and Vegetable Intake and Skin Carotenoids(Week 1-2, Week 11-12, and Week 34-36)
  • Physical Activity and Sedentary Behavior Time(Week 1-2, Week 11-12, and Week 34-36)
  • Dietary Intake by Food Screener Data in Cups(Week 1-2, Week 11-12, and Week 34-36)

研究者

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

Jason Mendoza, MD, MPH

Principal Investigator

Seattle Children's Hospital

研究点 (6)

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