Celiac Disease: Nutrition Education in Primary School (ZELIAKIDE)
Primary Purpose
Celiac Disease
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ZELIAKIDE
Sponsored by
About this trial
This is an interventional supportive care trial for Celiac Disease focused on measuring celiac disease, nutrition education, children, gluten-free diet, balanced diet
Eligibility Criteria
Inclusion Criteria:
- Schools of Vitoria-Gasteiz
- Have at least one class in grades 5th and 6th level of primary school.
Exclusion Criteria:
- Family or closed relationship with school students.
Sites / Locations
- Itziar Churruca OrtegaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental, nutrition education program
control group
Arm Description
Outcomes
Primary Outcome Measures
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).
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).
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).
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).
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).
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).
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05467865
First Posted
April 26, 2022
Last Updated
May 5, 2023
Sponsor
University of the Basque Country (UPV/EHU)
1. Study Identification
Unique Protocol Identification Number
NCT05467865
Brief Title
Celiac Disease: Nutrition Education in Primary School
Acronym
ZELIAKIDE
Official Title
A Quasi-experimental Intervention Protocol for Nutrition Education About Celiac Disease to Primary School Children (Zeliakide Project)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Basque Country (UPV/EHU)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
celiac disease, nutrition education, children, gluten-free diet, balanced diet
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental, nutrition education program
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
ZELIAKIDE
Intervention Description
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 Outcome Measure Information:
Title
Change in nutrition knowledge
Description
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).
Time Frame
4 weeks, twice a week
Title
Change in Celiac Disease knowledge
Description
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).
Time Frame
4 weeks, twice a week
Title
Change in intentional behavior related to the social inclusion of people with Celiac condition
Description
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).
Time Frame
4 weeks, twice a week
Title
Change in knowledge regarding gluten and its presence in food
Description
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).
Time Frame
4 weeks, twice a week
Title
Change in behavior in relation to interest in science
Description
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).
Time Frame
4 weeks, twice a week
Title
Change in behavior in relation to the consumption of unhealthy foods
Description
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).
Time Frame
4 weeks, twice a week
Secondary Outcome Measure Information:
Title
Opinion of the parents/guardians of the children in relation to the project
Description
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.
Time Frame
immediately after the intervention.
Title
Opinion of the children about the project reported by their parents/guardians
Description
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.
Time Frame
immediately after the intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Itziar Churruca Ortega
City
Vitoria-Gasteiz
State/Province
Álava
ZIP/Postal Code
01006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Itziar Churruca Ortega
Phone
+ 34 945 01 30 71
Email
itziar.txurruka@ehu.eus
First Name & Middle Initial & Last Name & Degree
Virginia Navarro Santamaria
First Name & Middle Initial & Last Name & Degree
Itziar Txurruka Ortega
First Name & Middle Initial & Last Name & Degree
Maialen Vázquez Polo
First Name & Middle Initial & Last Name & Degree
Arrate Lasa Elgezua
First Name & Middle Initial & Last Name & Degree
Idoia Larretxi Lamelas
First Name & Middle Initial & Last Name & Degree
Gesala Perez Junkera
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Citation
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Celiac Disease: Nutrition Education in Primary School
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