跳至主要内容
临床试验/NCT07232888
NCT07232888进行中(未招募)不适用

Design of a Multicomponent Intervention to Reduce the Risk of Exposure to High Concentrations of Fluoride in Children in Huila, Colombia

Universidad Antonio Nariño1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年5月2日最近更新:
适应症
干预措施

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

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

Experimental

干预措施: multicomponent intervention (Behavioral)

Control side

Active Comparator

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.)

研究者

发起方
Universidad Antonio Nariño
申办方类型
Other
责任方
Sponsor

研究点 (1)

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