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临床试验/NCT05467865
NCT05467865已完成不适用

A Quasi-experimental Intervention Protocol for Nutrition Education About Celiac Disease to Primary School Children (Zeliakide Project)

University of the Basque Country (UPV/EHU)2 个研究点 分布在 1 个国家目标入组 299 人开始时间: 2020年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
299
试验地点
2
主要终点
Change in behavior in relation to interest in science

研究概览

简要总结

Celiac disease is a chronic immune-based intestinal pathology. Its prevalence is 1% and its incidence has increased in recent years. This disease usually causes gastrointestinal and/or extraintestinal symptoms, which can only be reduced by following a strict, lifelong gluten-free diet. In addition, the social life of people with celiac disease is impaired due to the impact of the gluten-free diet on daily activities.

An adequate Nutrition Education program can improve the physical and social health of these people. Moreover, considering the high impact this disease has on the people close to the celiac patient, and due to the important role that general population has in the care and inclusion of persons with celiac disease, education should be directed to general population.

Therefore, the purpose of ZELIAKIDE program is to promote Nutrition Education in general population. In particular, the specific aims are 1) to promote the social inclusion of people with celiac disease by raising awareness among the general population, and 2) to promote a balanced diet and an interest in science and research among children.

ZELIAKIDE is an intervention aimed at children and focused on the school environment, and is based on Inquiry Based Learning (IBL) methodology. Inquiry-based Teaching-Learning Sequence (TLS) has been created to internalize and integrate competences related to celiac disease, gluten, gluten-free diet, balanced diet and healthy lifestyle.

In addition, this TLS aims to develop scientific competence through activities that promote science and the research process.

Although nutrition education programs for children have proven to be effective, it has been observed that children's interest in science has decreased. The investigators therefore aim to implement a nutrition education programme based on previous experiences that promotes science skills and stimulates children's interest in science.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
10 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • School must show interest in participating in the project.
  • Children study in a primary school that must be used to project based learning.
  • Have at least one class in grades 5th and 6th level of primary school.

排除标准

  • Family or closed relationship with school students.

结局指标

主要结局

Change in behavior in relation to interest in science

时间窗: 4 weeks, twice a week

The questionnaire will be used to measure the change (see explanation of the type of questionnaire in the first outcome measure). The change in knowledge regarding gluten and its presence in food will be measured in part 5 of the questionnaire. The unit of measure will be the score obtained in the questionnaires in order to assess behavior change (0, worst; 4, best).

Change in nutrition knowledge

时间窗: 4 weeks, twice a week

A questionnaire was designed to be able to assess all outcomes. It was divided into 8 parts: each one for each session, carried out in different days. The same questionnaire part is completed twice (before and after each session) in order to assess changes due to the intervention. Regarding the change in nutrition knowledge will be measured in parts 1 and 2 of the questionnaire. The unit of measure will be the score obtained in the questionnaires (0, worst - 4, best / the number of correct answers).

Change in knowledge regarding gluten and its presence in food

时间窗: 4 weeks, twice a week

The questionnaire will be used to measure the change (see explanation of the type of questionnaire in the first outcome measure). The change in knowledge regarding gluten and its presence in food will be measured in part 3, 4, 5, and 7 of the questionnaire. The unit of measure will be the score obtained in the questionnaires (0, worst - 4, best / the number of correct answers).

Change in intentional behavior related to the social inclusion of people with Celiac condition

时间窗: 4 weeks, twice a week

The questionnaire will be used to measure the change (see explanation of the type of questionnaire in the first outcome measure). The change in intentional behavior will be measured in part 3, 6 and 8 of the questionnaire. The unit of measure will be the score obtained in the questionnaires (0, worst - 4, best / the number of correct answers).

Change in behavior in relation to the consumption of unhealthy foods

时间窗: 4 weeks, twice a week

The questionnaire will be used to measure the change in behavior in relation to the consumption of unhealthy foods, it will be measured in parts 2-8. The unit of measure will be the score obtained in the questionnaires (0, worst - 5, best).

Change in Celiac Disease knowledge

时间窗: 4 weeks, twice a week

The questionnaire will be used to measure the change (see explanation of the type of questionnaire in the first outcome measure). The change in Celiac Disease knowledge will be measured in part 3 of the questionnaire. The unit of measure will be the score obtained in the questionnaires (0, worst - 4, best / the number of correct answers).

次要结局

  • Opinion of the parents/guardians of the children in relation to the project(immediately after the intervention.)
  • Opinion of the children about the project reported by their parents/guardians(immediately after the intervention.)

研究者

发起方
University of the Basque Country (UPV/EHU)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Itziar Churruca Ortega

Profesor Titular de Universidad - University Tenured Professor

University of the Basque Country (UPV/EHU)

研究点 (2)

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