Cluster-Randomized Controlled Trial (RCT) to Evaluate the Impact of a School-based Fruit and Vegetable Co-op on Cardiometabolic Health of Children and Parents in a Persistent Poverty Area
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 720
- 试验地点
- 2
- 主要终点
- Change in level of child Glycosylated hemoglobin (HbA1c)
研究概览
简要总结
The purpose of this study is to examine the effects of the (Brighter Bites (BB) intervention compared to a wait-list control group 9 months after the intervention on changes in primary child outcomes (HbA1c, and vegetable intake), on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (FV)), and the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes.
详细描述
The purpose of this study is to examine the effects of the (Brighter Bites (BB) intervention compared to wait-list control at post intervention on changes in primary child outcomes (HbA1c, and vegetable intake), to examine the effects of the BB intervention compared to wait-list control at 9-month post intervention on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (FV)),to examine the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes at 9-month post-intervention, using within-subject analyses, examine and compare the long-term and dose-response effects of the BB intervention strategies on diet, adiposity, and metabolic outcomes at 21-month follow-up in the children and to explore the moderating effects of social and environmental variables on program effectiveness.
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 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •enrollment of 100 1st, 2nd, and 3rd grade students
- •high proportion of children participating in the free and reduced lunch (FRL) program (>70%)
- •willingness to implement a coordinated school health (CSH) program
排除标准
- •Prior participation in BB in the previous school year
- •children or parents identified as special needs per school; or having any physical, cognitive, or psychological disability that would prevent participation in evaluation measures
结局指标
主要结局
Change in level of child Glycosylated hemoglobin (HbA1c)
时间窗: baseline, post intervention (9 months after baseline)
We will utilize the portable HbA1c analyzers (DCA Vantage analyzer) to assess HbA1c, during biometric events.
Change in amount of child vegetable intake as assessed by the VEGGIE METER®
时间窗: baseline, post intervention (9 months after baseline)
The VEGGIE METER® is used to obtain a child's quantitative metric of skin carotenoids, a proxy measure of FV intake for children. The VEGGIE METER® measures skin carotenoids as an indicator of FV intake. Higher number of carotenoid levels indicate more FV intake.
次要结局
- Change in household food security status as assessed by a parent survey(baseline, post intervention (9 months after baseline))
- Number of servings consumed by the Child as assessed by the NIH's Eating at America's Table questionnaire (All Day) and the Dietary Screener Questionnaires(baseline, post intervention (9 months after baseline))
- Child diastolic blood pressure(post intervention (9 months after baseline))
- Number of servings consumed by the parent as assessed by the Adapted Health of Houston Survey (HHS) on processed food/drinks 4-items, and fruit and vegetable intake 2 items.(baseline, post intervention (9 months after baseline))
- Child systolic blood pressure(Post intervention (9 months after baseline))
- Change in home access/availability of fruits and vegetables as assessed by the Nutrition security measures questionnaire(baseline, post intervention (9 months after baseline))
研究者
Shreela V Sharma
Professor
The University of Texas Health Science Center, Houston