CATCH Healthy Smiles: A Cluster-RCT of an Elementary School Oral Health Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,084
- 试验地点
- 1
- 主要终点
- Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
研究概览
简要总结
The purpose of this study is to clinically evaluate the effects of a school-based behavioral intervention, CATCH Healthy Smiles, to reduce the risk of dental caries in a cohort of kindergarten through 2nd grade (K-2) children serving low-income, ethnically-diverse children,to determine the impact of CATCH Healthy Smiles on child behavioral, psychosocial, and environmental outcomes beginning in K through 2nd grade, compared to children in the control schools and to examine the extent to which the child behavioral, psychosocial, and environmental factors mediate the improvements in child caries risk.
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
- Single (Investigator)
盲法说明
For post measurements, all data collection staff will be blinded to the intervention status.
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For schools:
- •greater than 75% of the children enrolled in the dree/reduced school lunch program.
- •enrolling children in grade K in the 2021-2022 school year.
- •agree to implement the CATCH Healthy Smiles program and agreed to participate in the measurements
- •For parent and child to participate in the measures:
- •ability of the parent to speak and read in English or Spanish at the 4th grade level,
- •child enrolled in the participating school in grade K in the 2021-2022 school year
- •child ability to participate in the regular activities at the school
排除标准
- •No congenital dental conditions such as cleft palate, children with enamel hypoplasia, severe fluorosis, or special dental setting needs.
研究组 & 干预措施
Comparison School Group
干预措施: Comparison School Group (Behavioral)
Intervention School Group
干预措施: Intervention School Group (Behavioral)
结局指标
主要结局
Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
时间窗: end of year 2(first grade)
number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
时间窗: end of year 3( second grade)
Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
时间窗: Baseline(beginning of kindergarten)
Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
时间窗: end of year 1(Kindergarten)
次要结局
- Number of children with good oral hygiene as measured by the child plaque index(end of year 3 about 33 months form start of intervention)
- Child dietary intake as measured by the Block food frequency screener(end of year 3)
- Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys(End of year 3 about 33 months from start of intervention)
- Frequency of flossing teeth for the child measured using parent self-report surveys(end of year 3)
- Number of times a child brushes their teeth a day(End of year 3 about 33 months from start of intervention)
- Change in Body Mass Index (BMI)(baseline, end of Year 1, Year 2 and Year 3)
- Change in Child Oral health quality of life measured using parent self-report surveys(baseline, end of Year 1, Year 2 and Year 3)
- Frequency of flossing teeth for the child measured using parent self-report surveys(end of year 2)
- Number of times a child brushes their teeth a day(end of year 1 about 9 months from start of intervention)
- Number of times a child brushes their teeth a day(End of year 2 about 23 months from start of intervention)
- Frequency of flossing teeth for the child measured using parent self-report surveys(Baseline)
- Number of children with good oral hygiene as measured by the child plaque index(Baseline)
- Number of children with good oral hygiene as measured by the child plaque index(end of year 1 about 9 months form start of intervention)
- Number of children with good oral hygiene as measured by the child plaque index(end of year 2 about 23 months from start of intervention)
- Child dietary intake as measured by the Block food frequency screener(Baseline)
- Frequency of flossing teeth for the child measured using parent self-report surveys(end of year 1)
- Child dietary intake as measured by the Block food frequency screener(end of year 1)
- Child dietary intake as measured by the Block food frequency screener(end of year 2)
- Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys(Baseline)
- Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys(end of year 1 about 9 months from start of intervention)
- Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys(End of year 2 about 23 months from start of intervention)
- Number of times a child brushes their teeth a day(Baseline)
研究者
Shreela V Sharma
Professor
The University of Texas Health Science Center, Houston