Celiac DiseaseZELIAKIDENCT05467865
Celiac Disease: Nutrition Education in Primary School
A study testing ZELIAKIDE in people with Celiac Disease, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease
- What is being tested?
- ZELIAKIDE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jun 2020to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Family or closed relationship with school students.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Quasi-experimental Intervention Protocol for Nutrition Education About Celiac Disease to Primary School Children (Zeliakide Project)
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.
Read more
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.
- Conditions
- Celiac Disease
- Being tested
- ZELIAKIDE
- Keywords
- celiac disease, nutrition education, children, gluten-free diet, balanced diet
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental, nutrition education program | Experimental | Not described Receives: Other: ZELIAKIDE |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks, twice a week
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).
Measured: 4 weeks, twice a week
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).
Measured: 4 weeks, twice a week
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).
Measured: 4 weeks, twice a week
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).
Measured: 4 weeks, twice a week
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).
Measured: 4 weeks, twice a week
Secondary outcomes (2)
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.
Measured: immediately after the intervention.
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.
Measured: immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start30 Jun 2020
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Basque Country (UPV/EHU)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Itziar Churruca Ortega, University of the Basque Country (UPV/EHU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467865
- Sponsor's protocol ID
- M10_2020_081 ZELIAKIDE
- Other IDs
- GIU18/078, IT1419-19
- Acronym
- ZELIAKIDE
- Status last verified
- Nov 2023
- First submitted
- 26 Apr 2022
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27886806Murimi 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.
PubMed 27814976Lasa 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.
PubMed 31627463Haas 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.
PubMed 28343658Halmos 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.
PubMed 29733115Patriota 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.
PubMed 28915797Li 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.
PubMed 31770371Minossi 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.
PubMed 25885095Gold 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.
PubMed 28076921Wall 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.
PubMed 22142173Vazquez-Polo M, Navarro V, Lasa A, Larretxi I, Perez-Junkera G, Matias S, Simon E, Churruca I. Assessment of a Non-Randomized Education Intervention for Primary School Aimed to Promote the Inclusion of People with Celiac Disease: Zeliakide Project (Part II). Nutrients. 2026 Jun 3;18(11):1798. doi: 10.3390/nu18111798.
PubMed 42280441Vazquez-Polo M, Churruca I, Lasa A, Perez-Junkera G, Larretxi I, Bustamante MA, Martinez O, Navarro V. Effectiveness of a controlled trial of nutrition education in primary school, ZELIAKIDE project: knowledge and mid-morning snack consumption. BMC Public Health. 2025 Dec 23;26(1):340. doi: 10.1186/s12889-025-25821-3.
PubMed 41437238
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quasi-experimental Intervention Protocol for Nutrition Education About Celiac Disease to Primary School Children (Zeliakide Project)
- ClinicalTrials.gov ID
- NCT05467865
- Acronym / sponsor ID
- ZELIAKIDE / M10_2020_081 ZELIAKIDE
- Conditions
- Celiac Disease
- Keywords
- celiac disease, nutrition education, children, gluten-free diet, balanced diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- University of the Basque Country (UPV/EHU)University, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental, nutrition education program | Experimental | Other: ZELIAKIDE |
| control group | No intervention | – |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Family or closed relationship with school students.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZELIAKIDEThe 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. | Other | Experimental, nutrition education program |
Primary outcome
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).
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).
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).
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).
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).
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).
2 secondary outcomes
Opinion of the parents/guardians of the children in relation to the project
Time frame: immediately after the intervention.
Opinion of the children about the project reported by their parents/guardians
Time frame: immediately after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Background: PubMed 27886806Sevinc 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.
- Background: PubMed 27814976Murimi 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.
- Background: PubMed 31627463Lasa 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.
- Background: PubMed 28343658Haas 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.
- Background: PubMed 29733115Halmos 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.
- Background: PubMed 28915797Patriota 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.
- Background: PubMed 31770371Li 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.
- Background: PubMed 25885095Minossi 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.
- Background: PubMed 28076921Gold 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.
- Background: PubMed 22142173Wall 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.
- Derived from this study: PubMed 42280441Vazquez-Polo M, Navarro V, Lasa A, Larretxi I, Perez-Junkera G, Matias S, Simon E, Churruca I. Assessment of a Non-Randomized Education Intervention for Primary School Aimed to Promote the Inclusion of People with Celiac Disease: Zeliakide Project (Part II). Nutrients. 2026 Jun 3;18(11):1798. doi: 10.3390/nu18111798.
- Derived from this study: PubMed 41437238Vazquez-Polo M, Churruca I, Lasa A, Perez-Junkera G, Larretxi I, Bustamante MA, Martinez O, Navarro V. Effectiveness of a controlled trial of nutrition education in primary school, ZELIAKIDE project: knowledge and mid-morning snack consumption. BMC Public Health. 2025 Dec 23;26(1):340. doi: 10.1186/s12889-025-25821-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZELIAKIDE in people with Celiac Disease, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nutrition knowledge (time frame: 4 weeks, twice a week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05467865, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.