CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 299 enrolled
Drug / intervention
ZELIAKIDEother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05467865
NCT05467865N/ACompleted

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

University of the Basque Country (UPV/EHU)·interventional·Posted Jul 21, 2022·Updated Nov 13, 2023

In Brief

A clinical study evaluating ZELIAKIDE for Celiac Disease. Completed, enrolled 299 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCeliac Disease
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 21, 2022
Enrollment StartJun 30, 2020
Primary CompletionNov 1, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 3.9 years ago

Interventions

ZELIAKIDEother

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.