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Completed

NCT Number: NCT05467865

Celiac Disease: Nutrition Education in Primary School

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.

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Itziar Churruca Ortega

Vitoria-Gasteiz, Álava, 01006, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZELIAKIDE

Other

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.

Primary outcomes

  1. Change in nutrition knowledge

    Time frame: 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).

  2. Change in Celiac Disease knowledge

    Time frame: 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).

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

    Time frame: 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).

  4. Change in knowledge regarding gluten and its presence in food

    Time frame: 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).

  5. Change in behavior in relation to interest in science

    Time frame: 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).

  6. Change in behavior in relation to the consumption of unhealthy foods

    Time frame: 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).

Secondary outcomes

  1. Opinion of the parents/guardians of the children in relation to the project

    Time frame: immediately after the intervention.

    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.

  2. Opinion of the children about the project reported by their parents/guardians

    Time frame: immediately after the intervention.

    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.

Sponsors and collaborators

Lead sponsor

University of the Basque Country (UPV/EHU)

Other

Registry information

Official study title

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

Acronym: ZELIAKIDE

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 21, 2022
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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