跳至主要内容
临床试验/NCT05758454
NCT05758454招募中不适用

Innovation Project Innovation Project for the Public Sector: Caries-Obesity Prevention in Children by Modifying Risk Behaviors Among Parents With Immigrant Background-COP Study

Oral Health Centre of Expertise in Western Norway2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2018年1月31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
发起方
入组人数
400
试验地点
2
主要终点
Change in poor parental knowledge regarding children oral health

研究概览

简要总结

Immigrants constitute 18.2 % of the whole population in Norway. Health inequalities were previously reported, and immigrant status has been associated with a high risk of caries and obesity in children. Lack of parental knowledge, poor communication, ethnic and cultural differences are suggested to be reasons for the observed discrepancies. Therefore, research-based knowledge about the social, psycho-social and cognitive factors, that direct health / dental health-related behavior in families with an immigrant background is needed.

Aims The main goal of this project is to assess attitudes and behaviors related to health/oral health among immigrant parents with newborn children (0-6 months). Develop an intervention programs with the aim of increasing the parent's knowledge of the children's oral hygiene/food habits and to evaluate in a follow-up study the effect of intervention on parents' knowledge and attitude with regard to dental caries and obesity.

Methods Parents with immigrant status will be recruited from primary health centers located in the western part of Norway when meeting for children's vaccination. Primary health care centers will be conveniently divided into an intervention and control group. Intervention in form of a health/dental health information translated into different native language will be provided for the intervention group. The control group will receive regular primary care health information. Efficacy of the intervention will be assessed as differences in change scores between intervention and control group regarding parental attitudes, knowledge and behaviors and children's quality of life related to health and oral health, children's body mass index and early childhood caries. Objective of this work are consistent with community needs to eliminate health/social inequalities and it is anticipated that a culturally adapted interventions can be implemented among immigrant families at a moderate cost.

详细描述

Detailed Description:

Project Plan

Innovation Project Innovation Project for the Public Sector. Innovative intervention: Caries-Obesity Prevention in children by modifying risk behaviors among parents with immigrant background-COP study

Project partner Oral Health Center of Expertise/Western Norway, Hordaland Manal I. Mustafa Sharafeldin Faculty of Medicine and Dentistry University of Bergen Årstadveien 19, Bergen, Norway Anne Nordrehaug Åstrøm Bergen Municipality TkMidtNorge

Rationale of the Study:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Parents having newborn infants (0-6 months) with Non-Western immigrant background

排除标准

  • •The parents will be excluded if they cannot understand and sign a consent form and are not willing to follow the the clinical trial procedures.

研究组 & 干预措施

Oral health information

Other

Intervention in form of a health/dental health information translated into different native language will be provided for the intervention group

干预措施: Caries and Obesity Prevention (Behavioral)

结局指标

主要结局

Change in poor parental knowledge regarding children oral health

时间窗: Response of parents to the first questionnaire when child is 6 months, and when the child is 24 months.

The questionnaire applied to the parents before and after cultured adapted informational to compare intervention will be used to measure the change of the parental knowledge. The comparison will be carried out between and within the control and intervention groups.

Change in poor parental behavior regarding children oral health

时间窗: Response of parents to the first questionnaire when child is 6 months, and when the child is 24 months.

The questionnaire applied to the parents before and after cultured adapted informational intervention will be used to measure the change of the parental behavior. The comparison will be carried out between and within the control and intervention groups.

次要结局

  • Quality of life of children /families(Response of parents to the first questionnaire when child is 3 years, and when the child is 3 years of age.)
  • Caries increment (Child age 24 months)(Clinical examination when child is 24 months (Duration of clinical examination 15 minutes for each child))
  • Caries increment (Child age 3 and 5 years old)(Registration of record at child aged 3 and 5 years old (Registration 15-20 minutes for each child))
  • Body Mass Index (BMI) (Child age 5 years old)(Response of parents to the first questionnaire when child is 3 years, and when the child is 3 years of age.)

研究者

发起方
Oral Health Centre of Expertise in Western Norway
申办方类型
Other
责任方
Principal Investigator
主要研究者

Manal Ibrahim Mustafa Sharafeldin

Researcher

Oral Health Centre of Expertise in Western Norway

研究点 (2)

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