Design of a Multicomponent Intervention to Reduce the Risk of Exposure to High Concentrations of Fluoride in Children in Huila, Colombia
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Urinary fluoride concentrations.
研究概览
简要总结
Introduction Systemic exposure to fluoride is a significant challenge for global public health; this is because although fluoride prevents dental caries, prolonged exposure to high concentrations can cause adverse effects on various organs and systems, especially the teeth. Despite the existence of preventive strategies to reduce this exposure, evidence on the effectiveness of multicomponent interventions is limited. This protocol describes the design of a randomized controlled trial to evaluate the effects of a multicomponent intervention on parents and children to reduce the risk of exposure to high concentrations of fluoride in children.
Methods This is a randomized controlled trial, and kindergartens in the municipalities of the Department of Huila, Colombia, will be recruited. The intervention group will receive a comprehensive five-component program: installation of water filters to reduce fluoride consumption; educational sessions for parents and children to raise awareness and promote healthy practices; outreach activities to strengthen collective knowledge; and a maintenance phase to ensure the program's sustainability. In contrast, the control group will participate in a conventional educational strategy focused on the parent-child dyad. Measurements will be taken at four points in time: pre-intervention for baseline and post-intervention at 3, 6, and 12 months. The evaluation of results includes the concentration of fluoride in children's urine, fluoride levels in water (to validate the effectiveness of filtration), and changes in parents' knowledge, attitudes, and practices.
Discussion The trial will evaluate the effectiveness of a multicomponent intervention aimed at parents and children to reduce the risk of fluoride exposure. Through integrative methodological approaches and objective measurements, it will demonstrate significant improvements in reducing fluoride exposure in children and in parents' knowledge, attitudes, and practices. It will contribute to child health programs, strengthen preventive oral health strategies with an impact on public policy, community health, and new lines of research on fluoride.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 5 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Kindergartens located in municipalities with exposure to fluoride concentrations in water.
- •Have a school feeding program.
- •The child must be enrolled.
- •They must be registered in the school feeding program.
- •The primary caregiver must be able to read.
- •The caregiver must agree to participate voluntarily and sign the informed consent form.
- •The caregiver must commit to attending all components of the intervention (education and collection of the child's urine sample).
排除标准
- •Parents or children with conditions or situations that may interfere with the assimilation of the components of the strategy.
- •Children who wear diapers will be excluded from the study.
研究组 & 干预措施
Experimental Side
干预措施: multicomponent intervention (Behavioral)
Control side
干预措施: Conventional intervention (Behavioral)
结局指标
主要结局
Urinary fluoride concentrations.
时间窗: Baseline, 3 , 6, and 12 months.
Decrease in urinary fluoride concentrations in children.
次要结局
- Knowledge, attitudes, and practices (KAP).(Baseline, 3 , 6 and 12 months.)
- fluoride concentrations in water.(baseline, 3, 6, and 12 months.)
