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

• ClinicalTrials.gov Identifier: NCT05923346
• Recruitment Status: Completed
• First Posted: June 28, 2023
• Last Update Posted: November 13, 2023
• Sponsor: University of the Basque Country (UPV/EHU)
• Information provided by (Responsible Party): Itziar Churruca Ortega, University of the Basque Country (UPV/EHU)

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Celiac Disease	Other: GLUTLEARN	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 93 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Educational Intervention on Celiac Disease and Gluten-free Diet Through Social Networks (GLUTLEARN Project).
• Actual Study Start Date: February 1, 2022
• Actual Primary Completion Date: November 1, 2023
• Actual Study Completion Date: November 1, 2023

Arms and Interventions

Arm

Intervention/treatment

Experimental: Glutlearn

Other: GLUTLEARN; 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.

Outcome Measures

Primary Outcome Measures :

1. Knowledge regarding celiac disease [ Time Frame: 5 weeks ]
   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).
2. Attitude towards celiac disease: degree of concern [ Time Frame: 5 weeks ]
   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).
3. Knowledge regarding balanced GFD [ Time Frame: 5 weeks ]
   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).
4. Knowledge regarding food labels [ Time Frame: 5 weeks ]
   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. Attitude: degree of confidence in their choice of food [ Time Frame: 5 weeks ]
   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).
6. Knowledge regarding cross-contact [ Time Frame: 5 weeks ]
   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).
7. Attitude: degree of confidence in avoiding cross-contact [ Time Frame: 5 weeks ]
   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).
8. Knowledge regarding new research in CD [ Time Frame: 5 weeks ]
   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).

Secondary Outcome Measures :

1. Satisfaction about the education received [ Time Frame: Immediately after the intervention ]
   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).
2. Perception of the importance of educational activities [ Time Frame: Immediately after the intervention ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Spain

University of the Basque Country (UPV/EHU)

Vitoria-Gasteiz, Álava, Spain, 01006

Sponsors and Collaborators

University of the Basque Country (UPV/EHU)

More Information

Publications of Results:

Vazquez-Polo M, Navarro V, Larretxi I, Perez-Junkera G, Lasa A, Matias S, Simon E, Churruca I. Uncovering the Concerns and Needs of Individuals with Celiac Disease: A Cross-Sectional Study. Nutrients. 2023 Aug 22;15(17):3681. doi: 10.3390/nu15173681.

Other Publications:

Lebwohl B, Rubio-Tapia A. Epidemiology, Presentation, and Diagnosis of Celiac Disease. Gastroenterology. 2021 Jan;160(1):63-75. doi: 10.1053/j.gastro.2020.06.098. Epub 2020 Sep 18.

Singh P, Arora A, Strand TA, Leffler DA, Catassi C, Green PH, Kelly CP, Ahuja V, Makharia GK. Global Prevalence of Celiac Disease: Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2018 Jun;16(6):823-836.e2. doi: 10.1016/j.cgh.2017.06.037. Epub 2018 Mar 16.

Itzlinger A, Branchi F, Elli L, Schumann M. Gluten-Free Diet in Celiac Disease-Forever and for All? Nutrients. 2018 Nov 18;10(11):1796. doi: 10.3390/nu10111796.

Rosen A, Ivarsson A, Nordyke K, Karlsson E, Carlsson A, Danielsson L, Hogberg L, Emmelin M. Balancing health benefits and social sacrifices: a qualitative study of how screening-detected celiac disease impacts adolescents' quality of life. BMC Pediatr. 2011 May 10;11:32. doi: 10.1186/1471-2431-11-32.

Olsson C, Lyon P, Hornell A, Ivarsson A, Sydner YM. Food that makes you different: the stigma experienced by adolescents with celiac disease. Qual Health Res. 2009 Jul;19(7):976-84. doi: 10.1177/1049732309338722.

Cadenhead JW, Wolf RL, Lebwohl B, Lee AR, Zybert P, Reilly NR, Schebendach J, Satherley R, Green PHR. Diminished quality of life among adolescents with coeliac disease using maladaptive eating behaviours to manage a gluten-free diet: a cross-sectional, mixed-methods study. J Hum Nutr Diet. 2019 Jun;32(3):311-320. doi: 10.1111/jhn.12638. Epub 2019 Mar 5.

Wolf RL, Lebwohl B, Lee AR, Zybert P, Reilly NR, Cadenhead J, Amengual C, Green PHR. Hypervigilance to a Gluten-Free Diet and Decreased Quality of Life in Teenagers and Adults with Celiac Disease. Dig Dis Sci. 2018 Jun;63(6):1438-1448. doi: 10.1007/s10620-018-4936-4. Epub 2018 Jan 31. Erratum In: Dig Dis Sci. 2018 Apr 11;:

Singh P, Dennis M. Eliminating Dietary Gluten: Don't Be a "Glutton for Punishment". Dig Dis Sci. 2018 Jun;63(6):1374-1375. doi: 10.1007/s10620-018-5010-y. No abstract available.

Al Sarkhy A. Social media usage pattern and its influencing factors among celiac patients and their families. Saudi J Gastroenterol. 2020 Mar-Apr;26(2):99-104. doi: 10.4103/sjg.SJG_495_19.

McNally SL, Donohue MC, Newton KP, Ogletree SP, Conner KK, Ingegneri SE, Kagnoff MF. Can consumers trust web-based information about celiac disease? Accuracy, comprehensiveness, transparency, and readability of information on the internet. Interact J Med Res. 2012 Apr 4;1(1):e1. doi: 10.2196/ijmr.2010.

Trovato CM, Montuori M, Oliva S, Cucchiara S, Cignarelli A, Sansone A. Assessment of public perceptions and concerns of celiac disease: A Twitter-based sentiment analysis study. Dig Liver Dis. 2020 Apr;52(4):464-466. doi: 10.1016/j.dld.2020.02.004. Epub 2020 Feb 29. No abstract available.

• Responsible Party: Itziar Churruca Ortega, Profesor Titular de Universidad - University Tenured Professor, University of the Basque Country (UPV/EHU)
• ClinicalTrials.gov Identifier: NCT05923346
• Other Study ID Numbers: M10_2020_081 GLUTLEARN; GIU18/78 ( Other Grant/Funding Number: University of the Basque Country (UPV/EHU) ); GIU21/053 ( Other Grant/Funding Number: University of the Basque Country (UPV/EHU) ); IT-1419-19 ( Other Grant/Funding Number: Basque Government ); University-Society US22/22 ( Other Grant/Funding Number: University of the Basque Country (UPV/EHU) )
• First Posted: June 28, 2023
• Last Update Posted: November 13, 2023
• Last Verified: November 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Itziar Churruca Ortega, University of the Basque Country (UPV/EHU):

celiac disease; nutrition education; gluten-free diet; balanced diet; social networks

Additional relevant MeSH terms:

Celiac Disease; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases