Clinical trial NCT05467865: Celiac Disease: Nutrition Education in Primary School
Official title: A Quasi-experimental Intervention Protocol for Nutrition Education About Celiac Disease to Primary School Children (Zeliakide Project)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Celiac Disease
Keywords: celiac disease
nutrition education
children
gluten-free diet
balanced diet
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 299
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in nutrition knowledge
timeFrame: 4 weeks, twice a week
measure: Change in Celiac Disease knowledge
timeFrame: 4 weeks, twice a week
measure: Change in intentional behavior related to the social inclusion of people with Celiac condition
timeFrame: 4 weeks, twice a week
measure: Change in knowledge regarding gluten and its presence in food
timeFrame: 4 weeks, twice a week
measure: Change in behavior in relation to interest in science
timeFrame: 4 weeks, twice a week
measure: Change in behavior in relation to the consumption of unhealthy foods
timeFrame: 4 weeks, twice a week
Secondary outcomes:
measure: Opinion of the parents/guardians of the children in relation to the project
timeFrame: immediately after the intervention.
measure: Opinion of the children about the project reported by their parents/guardians
timeFrame: immediately after the intervention.
Other outcomes:
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: Itziar Churruca Ortega
state: Álava
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.