Educational Intervention on Celiac Disease and Gluten-free Diet Through Social Networks (GLUTLEARN Project).

Study Overview
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Brief Summary
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Celiac disease (CD) is an autoimmune disease that occurs in people who are genetically predisposed to gluten consumption (1). The prevalence of the disease is about 1-2% and it is more common in women than in men, and in children than in adults (2). The only current treatment for celiac disease is a strict, lifelong gluten-free diet. This involves the complete elimination of gluten from the diet. Gluten is not only present in some cereals such as wheat, rye, barley and oats, but is also found in many foods that have been processed. In addition to being safe, the gluten-free diet must also be balanced. Following a gluten-free diet creates psychological and social problems for the people who have to follow it (3). It has been seen in several studies that people with celiac condition can feel different and excluded, as it is difficult to eat out, to make sure that the food is gluten-free and to avoid cross-contact (4-8). Due to the complicate situation of people with celiac disease, they do not hesitate to seek information about the management of their diseas. That is why people with celiac disease turn to social networks, as a rapid, visual and accessible way to share information (9-11). In line with the objectives of the University to which the Gluten3S research group belongs to (University of the Basque Country, UPV/EHU), the group has been aware for some time of the importance of disseminating science on social networks in order to make the results of the research reach the general public. It is considered that creating a nutritional education programme about CD and Gluten-Free Diet (GFD), delivered by experts in the field, could be useful in improving knowledge and attitudes about this matter. This will empower people with CD to improve their self-care and take control of their situation. Furthermore, it is also interesting to design the programme in such a way that the impact of the intervention can be measured, always with the intention of continuous improvement and reaching people with celiac disease and their environment in an effective way. The educational intervention will be carried out for one month and is aimed at adults with coeliac disease or adults with coeliac relatives who are involved in their care. Each day a post will be uploaded to Instagram with specific, accurate and current information. The content of the intervention has been divided into 5 main blocks: 1) general concepts about CD, 2) balanced GFD, 3) food labelling, 4) cross-contact/cross-contamination, 5) new research on CD and useful resources for disease management. The evaluation of the intervention will be carried out through pre- and post-intervention questionnaires.

Official Title
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Educational Intervention on Celiac Disease and Gluten-free Diet Through Social Networks (GLUTLEARN Project).

Conditions
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Celiac Disease

Intervention / Treatment
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* Other: GLUTLEARN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be of legal age Have celiac disease or be involved in the care of a person with celiac disease Be an Instagram user

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glutlearn<br> | Other: GLUTLEARN<br>* The group will be made up of users of the social network Instagram who have celiac disease or are close to a celiac patient (parent/guardian of celiac children or cohabitants). The intervention will be carried out through the social network Instagram. Participants will be recruited through the same social network. Participants must agree to take part in the study. The educational intervention will be carried out for one month, where each day a post will be uploaded with specific, truthful and current information. The content of the intervention has been divided into 5 main blocks: 1) general concepts about CD, 2) balanced GFD, 3) food labelling, 4) cross-contact/cross-contamination, 5) new research on CD and useful resources for disease management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge regarding celiac disease | A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers). | 5 weeks | 
| Attitude towards celiac disease: degree of concern | A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers). | 5 weeks | 
| Knowledge regarding balanced GFD | A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers). | 5 weeks | 
| Knowledge regarding food labels | A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers). | 5 weeks | 
| Attitude: degree of confidence in their choice of food | A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers). | 5 weeks | 
| Knowledge regarding cross-contact | A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers). | 5 weeks | 
| Attitude: degree of confidence in avoiding cross-contact | A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers). | 5 weeks | 
| Knowledge regarding new research in CD | A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test) in order to assess changes due to the intervention.The unit of measure will be the score obtained in the questionnaires (0, worst-1,best/0, disagree-4,agree/the number of correct answers). | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction about the education received | A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test). Secondary outcomes will be measured in the post-questionnaire. • The unit of measure will be the score obtained in the questionnaires (0, disagree-4,agree). | Immediately after the intervention | 
| Perception of the importance of educational activities | A questionnaire will be used to be able to assess all outcomes. The same questionnaire will be completed twice, once before the intervention (pre-test) and again immediately after the end of the intervention (post-test). Secondary outcomes will be measured in the post-questionnaire. • The unit of measure will be the score obtained in the questionnaires (0, disagree-4,agree). | Immediately after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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celiac disease, nutrition education, gluten-free diet, balanced diet, social networks