Celiac Disease: Nutrition Education in Primary School

NCT ID: NCT05467865

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

299 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2023-11-01

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.

Detailed Description

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Conditions

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Celiac Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental, nutrition education program

Group Type EXPERIMENTAL

ZELIAKIDE

Intervention Type 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.

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ZELIAKIDE

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.

Intervention Type OTHER

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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of the Basque Country (UPV/EHU)

OTHER

Sponsor Role lead

Responsible Party

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Itziar Churruca Ortega

Profesor Titular de Universidad - University Tenured Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Itziar Churruca Ortega

Vitoria-Gasteiz, Álava, Spain

Site Status

Countries

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Spain

References

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Sevinc E, Cetin FH, Coskun BD. Psychopathology, quality of life, and related factors in children with celiac disease. J Pediatr (Rio J). 2017 May-Jun;93(3):267-273. doi: 10.1016/j.jped.2016.06.012. Epub 2016 Nov 23.

Reference Type BACKGROUND
PMID: 27886806 (View on PubMed)

Murimi MW, Kanyi M, Mupfudze T, Amin MR, Mbogori T, Aldubayan K. Factors Influencing Efficacy of Nutrition Education Interventions: A Systematic Review. J Nutr Educ Behav. 2017 Feb;49(2):142-165.e1. doi: 10.1016/j.jneb.2016.09.003. Epub 2016 Nov 1.

Reference Type BACKGROUND
PMID: 27814976 (View on PubMed)

Lasa A, Larretxi I, Simon E, Churruca I, Navarro V, Martinez O, Bustamante MA, Miranda J. New Software for Gluten-Free Diet Evaluation and Nutritional Education. Nutrients. 2019 Oct 17;11(10):2505. doi: 10.3390/nu11102505.

Reference Type BACKGROUND
PMID: 31627463 (View on PubMed)

Haas K, Martin A, Park KT. Text Message Intervention (TEACH) Improves Quality of Life and Patient Activation in Celiac Disease: A Randomized Clinical Trial. J Pediatr. 2017 Jun;185:62-67.e2. doi: 10.1016/j.jpeds.2017.02.062. Epub 2017 Mar 23.

Reference Type BACKGROUND
PMID: 28343658 (View on PubMed)

Halmos EP, Deng M, Knowles SR, Sainsbury K, Mullan B, Tye-Din JA. Food knowledge and psychological state predict adherence to a gluten-free diet in a survey of 5310 Australians and New Zealanders with coeliac disease. Aliment Pharmacol Ther. 2018 Jul;48(1):78-86. doi: 10.1111/apt.14791. Epub 2018 May 7.

Reference Type BACKGROUND
PMID: 29733115 (View on PubMed)

Patriota PF, Filgueiras AR, de Almeida VBP, Alexmovitz GAC, da Silva CE, de Carvalho VFF, Carvalho N, de Albuquerque MP, Domene SMA, do Prado WL, Torres GES, de Oliveira APR, Sesso R, Sawaya AL. Effectiveness of a 16-month multi-component and environmental school-based intervention for recovery of poor income overweight/obese children and adolescents: study protocol of the health multipliers program. BMC Public Health. 2017 Sep 15;17(1):708. doi: 10.1186/s12889-017-4715-8.

Reference Type BACKGROUND
PMID: 28915797 (View on PubMed)

Li B, Pallan M, Liu WJ, Hemming K, Frew E, Lin R, Liu W, Martin J, Zanganeh M, Hurley K, Cheng KK, Adab P. The CHIRPY DRAGON intervention in preventing obesity in Chinese primary-school--aged children: A cluster-randomised controlled trial. PLoS Med. 2019 Nov 26;16(11):e1002971. doi: 10.1371/journal.pmed.1002971. eCollection 2019 Nov.

Reference Type BACKGROUND
PMID: 31770371 (View on PubMed)

Minossi V, Pellanda LC. The "Happy Heart" educational program for changes in health habits in children and their families: protocol for a randomized clinical trial. BMC Pediatr. 2015 Mar 10;15:19. doi: 10.1186/s12887-015-0336-5.

Reference Type BACKGROUND
PMID: 25885095 (View on PubMed)

Gold A, Larson M, Tucker J, Strang M. Classroom Nutrition Education Combined With Fruit and Vegetable Taste Testing Improves Children's Dietary Intake. J Sch Health. 2017 Feb;87(2):106-113. doi: 10.1111/josh.12478.

Reference Type BACKGROUND
PMID: 28076921 (View on PubMed)

Wall DE, Least C, Gromis J, Lohse B. Nutrition education intervention improves vegetable-related attitude, self-efficacy, preference, and knowledge of fourth-grade students. J Sch Health. 2012 Jan;82(1):37-43. doi: 10.1111/j.1746-1561.2011.00665.x.

Reference Type BACKGROUND
PMID: 22142173 (View on PubMed)

Other Identifiers

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GIU18/078

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IT1419-19

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

M10_2020_081 ZELIAKIDE

Identifier Type: -

Identifier Source: org_study_id

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