Celiac Disease: Nutrition Education in Primary School

Study Overview
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Brief Summary
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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.

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

Conditions
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Celiac Disease

Intervention / Treatment
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* Other: ZELIAKIDE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Family or closed relationship with school students.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental, nutrition education program<br> | Other: ZELIAKIDE<br>* The nutrition education program will be adapted to the curriculum of the schools. The intervention will consist of 8 sessions and the main topics will be: (1) to understand the balanced diet and to apply it to one´s own diet, (2) to learn what celiac disease and gluten are, (3) to promote social inclusion. Each session will last 60 minutes and they will take place during school hours. The whole intervention will last 4 weeks, 2 sessions per week. Teaching-learning process will be developed through games and experiments. Designed activities are based on IBL methodology, which has proven to be very effective in science teaching-learning processes. As a result, inquiry-oriented TLS has been developed, focused on facilitating children's understanding of the research process.<br>|
| No Intervention: control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nutrition knowledge | 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). | 4 weeks, twice a week | 
| Change in Celiac Disease knowledge | 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). | 4 weeks, twice a week | 
| Change in intentional behavior related to the social inclusion of people with Celiac condition | 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). | 4 weeks, twice a week | 
| Change in knowledge regarding gluten and its presence in food | 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). | 4 weeks, twice a week | 
| Change in behavior in relation to interest in science | 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). | 4 weeks, twice a week | 
| Change in behavior in relation to the consumption of unhealthy foods | 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). | 4 weeks, twice a week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opinion of the parents/guardians of the children in relation to the project | A separate questionnaire will be completed by parents/guardians of the participants. This questionnaire will measure the two secondary outcomes. The answers to the questionnaire will be yes/no/don't know. | immediately after the intervention. | 
| Opinion of the children about the project reported by their parents/guardians | A separate questionnaire will be completed by parents/guardians of the participants. This questionnaire will measure the two secondary outcomes. The answers to the questionnaire will be yes/no/don't know. | immediately after the intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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celiac disease, nutrition education, children, gluten-free diet, balanced diet