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临床试验/NCT07011602
NCT07011602招募中不适用

INTEGRATED CHILDHOOD ACTIVITY AND NUTRITION (ICAN) STUDY

University of Illinois at Urbana-Champaign1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年6月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Academic Achievement

研究概览

简要总结

This study is a multi-functional integrated research and education project to prevent losses in academic achievement, cognitive function, and behavioral health among at-risk youth. The study tests the effects of a 8-week nutrition and physical activity-based program (Integrated Childhood Activity and Nutrition [ICAN]) to prevent summer learning loss. Outcomes include standardized academic achievement as well as executive function among 6-10-year-olds affected by poverty. The nutrition component of the intervention involves daily consumption of a snack containing the carotenoid lutein, typically found in high quantities in green leafy vegetables. The physical activity components will involve group games or activities.

详细描述

During the summer period it is estimated that children, especially those from impoverished settings, could lose up to 30% of learning gained during the school year. Additionally, the loss in learning accompanied by increased risk for obesity. Children's dietary intake, particularly of nutrient-dense dark green leafy vegetables, has persistently fallen below dietary recommendations. Similarly, there has been a decline in children's aerobic fitness since the 1970s. Despite consistent and widespread efforts, there has been limited progress in improving children's dietary habits, habitual physical activity engagement, and reducing child obesity. One reason for this perpetual challenge is that educational and intervention efforts typically occur during the school year. However, it is the summer, not the school year, when accelerated increases in body fat and decline in diet quality and physical activity tend to occur. Student summer learning loss, a phenomenon commonly referred to as the summer slide, is the loss of academic knowledge and/or skills during the summer. Students' achievement scores decline over the summer by one month's worth of school-year learning instruction. Additionally, these effects are more pronounced black and Latino students who not only tend to gain less over the school year but exhibit greater learning loss in the summer, compared to white students. This is at least in part because during summer, fewer opportunities exist for children from low-income households to access healthy structured programs. Therefore, efficacious nutrition and physical activity-based programs are critically needed, especially during summer, a period of vulnerability among children affected by poverty.

This work will conduct an 8-week physical activity and nutrition randomized controlled trial among children during the summer period. The specific aims are outlined below.

Specific Aim 1: To investigate the effects of combining an 8-week lutein intervention (6mg lutein/day) with a social emotional learning (SEL)-framed physical activity summer intervention (ICAN) on improving academic achievement and cognition among school children (6-11-year-olds) affected by poverty.

Specific Aim 2: To investigate the effects of the ICAN program on improvement in carotenoid status and implications for academics and cognition in 6-11-year-olds from impoverished settings.

Specific Aim 3: To investigate ICAN intervention effects on weight status and adiposity.

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
6 Years 至 11 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Parental/guardian consent
  • •Child assent
  • •Child participant is between the chronological age of 6-11 years.
  • •Child participant is considered economically or educationally disadvantaged (e.g., eligible for Supplemental Nutritional Assistance Program [SNAP] and/or qualifies for free-and-reduced lunch.
  • •Child participant must have 20/20 or corrected 20/20 vision.
  • •Child participant absent of cognitive or neurological disorder (e.g., autism spectrum disorder)

排除标准

  • •Parental/guardian does not provide consent
  • •Child non-assent
  • •Child participant chronological age when enrolling into the iCANS program falls below 6 or above 11 years of age
  • •Child participant is not eligible for SNAP or does not qualify for free-and-reduced lunch.
  • •Child participant does not have 20/20 or corrected 20/20 vision.
  • •Presence of cognitive or neurological disorder (e.g., autism spectrum disorder)

研究组 & 干预措施

Treatment Group

Experimental

8-week Physical Activity and Nutrition

干预措施: 8-week Physical Activity and Nutrition Program (Behavioral)

Control

No Intervention

Waitlist Control

结局指标

主要结局

Academic Achievement

时间窗: Baseline vs. 8 week Post-test

Composite score on the standardized Kaufman Test of Academic and Educational Achievement 3-(KTEA-3)

次要结局

  • Retinal Xanthophylls(Baseline vs. 8 week Post-test)
  • Attentional Inhibition(Baseline vs. 8-week Post-test)
  • Attentional Resource Allocation(Baseline vs. 8 week Post-test)
  • Processing Speed(Baseline vs. 8 week Post-test)
  • Skin Carotenoids(Baseline vs. 8 week Post-test)
  • Weight status(Baseline vs. 8 week Post-test)
  • Adiposity(Baseline vs. 8 week Post-test)
  • Nutrition Literacy(Baseline vs. 8 week Post-test)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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