Coeliac DiseaseNCT07172555
Virtual Dietetic Interventions in Patients With Coeliac
A study testing Virtual Dietetic First-Appointment Webinar for Coeliac Disease and Standard Dietetic Consultation (Face-to-Face or Telephone) in people with Coeliac Disease, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This clinical study is exploring whether a pre-recorded, on-demand webinar led by specialist dietitians can be as effective as traditional one-on-one appointments in helping people newly diagnosed with coeliac disease learn to follow a gluten-free diet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coeliac Disease
- What is being tested?
- Virtual Dietetic First-Appointment Webinar for Coeliac Disease and Standard Dietetic Consultation (Face-to-Face or Telephone)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2025to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and over with serology- or biopsy-proven coeliac disease.
Who cannot join
- Patients under the age of 18 years. Patients unable to provide written informed consent. Patients who are unable to understand or speak English. Patients unable to access digital resources. Poly-diagnosis that requires additional nutritional intervention (i.e. Diabetes or Inflammatory Bowel Disease).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Arkadeep Dhali, MBBS, MPH contact
United Kingdom1 site, 1 recruiting
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S57AU
Jemima Clarke, 01142265943, sth.researchadministration@nhs.net
David S Sanders, MBChB, MD, FRCP, FACG
About this study
Official title: The Role Of Virtual Dietetic Interventions In Patients With Coeliac Disease
This clinical study is exploring whether a pre-recorded, on-demand webinar led by specialist dietitians can be as effective as traditional one-on-one appointments in helping people newly diagnosed with coeliac disease learn to follow a gluten-free diet. Coeliac disease is a serious, life-long condition where eating even tiny amounts of gluten, a substance found in wheat, barley, and rye, can cause damaging symptoms and long-term health problems. The only current treatment is sticking to a strict gluten-free diet, which can be difficult without proper support and guidance from dietitians.
The number of people being diagnosed with coeliac disease in the UK is growing, and this is placing extra pressure on NHS dietetic services, which are already stretched. Many patients currently face long waits or do not get any dietetic support at all. To address this, the research team at Sheffield Teaching Hospitals has developed an on-demand, first-appointment webinar to provide immediate access to trusted dietary information, with the aim of improving patient care and saving NHS resources.
Read more
In this study, adults newly diagnosed with coeliac disease at Sheffield Teaching Hospitals will be asked to join one of two groups: one group will receive their first dietitian appointment through the new on-demand webinar, while the other group will have a traditional face-to-face or phone appointment with a dietitian. Both groups will complete short questionnaires to measure their knowledge about the gluten-free diet, their symptoms, how well they are following the diet, and their quality of life, both before and after receiving their dietary support, and again after six months. Blood tests will also be used to monitor health markers.
The main goal of the research is to find out if the first-appointment webinar is just as effective as traditional appointments in helping patients understand and follow a gluten-free diet, feel satisfied with the support they receive, and achieve good health outcomes. If the study shows that the webinar approach is as good as traditional care, it could mean quicker, easier, and more consistent access to essential dietary support for people with coeliac disease, both locally and across the UK.
Hypothesis:
The study hypothesis is that a dietitian-led, on-demand, pre-recorded webinar for a first appointment is as effective as traditional one-to-one consultations (face-to-face or by phone) in helping newly diagnosed coeliac patients achieve the same standard health outcomes, dietary knowledge, and satisfaction with care.
- Conditions
- Coeliac Disease
- Being tested
- Virtual Dietetic First-Appointment Webinar for Coeliac Disease, Standard Dietetic Consultation (Face-to-Face or Telephone)
- Keywords
- coeliac disease, diet, webinar
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Dietetic First-Appointment Webinar for Coeliac DiseaseOther
This intervention is a dietitian-led, pre-recorded on-demand webinar specifically designed for adults who have been newly diagnosed with coeliac disease. It acts as a patient's first formal dietetic appointment after diagnosis and provides comprehensive education about coeliac disease and the strict gluten-free diet required for its management. Unlike traditional approaches, which rely on face-to-face or telephone appointments with a dietitian-and which often involve significant waiting times-the webinar is available immediately online, allowing patients to access trusted, specialist information at their own pace and convenience, including the opportunity to re-watch as needed
Standard Dietetic Consultation (Face-to-Face or Telephone)Other
Participants in this group are allocated to receive the existing standard of care: an individual appointment with a specialist dietitian, delivered either in person (face-to-face) or by telephone. During the appointment, the dietitian provides a comprehensive overview of the gluten-free diet, strategies for avoiding cross-contamination, and advice on nutritional adequacy. As in the experimental arm, baseline assessment and validated questionnaires are administered pre- and post-intervention, with follow-up at 6 months to collect clinical, adherence, satisfaction, and quality of life data for direct comparison with the on-demand webinar intervention.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Dietetic First-Appointment Webinar for Coeliac Disease | Experimental | Participants allocated to this arm will receive a pre-recorded, dietitian-led "first appointment" webinar designed specifically for adults newly diagnosed with coeliac disease. The webinar will provide comprehensive education on the gluten-free diet, approaches to avoid cross-contamination, and strategies for nutritional adequacy. The intervention allows participants to watch and re-watch the webinar at their convenience. All participants will undergo baseline assessments and will complete knowledge and satisfaction questionnaires immediately post-intervention, with follow-up clinical and patient-reported outcomes collected at 6 months. Receives: Other: Virtual Dietetic First-Appointment Webinar for Coeliac Disease |
| Standard Dietetic Consultation (Face-to-Face or Telephone) | Active comparator | Participants in this group are allocated to receive the existing standard of care: an individual appointment with a specialist dietitian, delivered either in person (face-to-face) or by telephone. During the appointment, the dietitian provides a comprehensive overview of the gluten-free diet, strategies for avoiding cross-contamination, and advice on nutritional adequacy. As in the experimental arm, baseline assessment and validated questionnaires are administered pre- and post-intervention, with follow-up at 6 months to collect clinical, adherence, satisfaction, and quality of life data for direct comparison with the on-demand webinar intervention. Receives: Other: Standard Dietetic Consultation (Face-to-Face or Telephone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knowledge of Gluten-Free Diet
Assessed using the Coeliac Disease and Gluten-Free Diet Quiz, a structured and previously validated questionnaire administered at baseline, immediately post-intervention, and at 6 months. This tool evaluates patient knowledge related to coeliac disease and the gluten-free diet requirements for effective disease management. Scores pre- and post-intervention (webinar or standard care) will be compared to determine the educational impact of each modality.
Measured: Baseline (pre-intervention), immediately post-intervention, and at 6-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Dec 2025
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coeliac 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172555
- Sponsor's protocol ID
- STH22680
- Status last verified
- Mar 2026
- First submitted
- 3 Sep 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie published results will be made available to researchers upon reasonable request following completion of the trial and publication of the main findings. Data will be stored securely and released only with appropriate approvals, in accordance with the Data Protection Act 2018 and Sheffield Teaching Hospitals NHS Trust policies. Requests for access may come from both internal and external research collaborators, and all IPD will be stripped of direct patient identifiers prior to sharing.
Publications
Rej A, Trott N, Kurien M, Branchi F, Richman E, Subramanian S, Sanders DS. Is Peer Support in Group Clinics as Effective as Traditional Individual Appointments? The First Study in Patients With Celiac Disease. Clin Transl Gastroenterol. 2020 Jan;11(1):e00121. doi: 10.14309/ctg.0000000000000121.
PubMed 31977451Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9.
PubMed 22169081Rej A, Buckle RL, Shaw CC, Trott N, Urwin H, McGough N, Aziz I, Sanders DS. National survey evaluating the provision of gastroenterology dietetic services in England. Frontline Gastroenterol. 2020 Jun 16;12(5):380-384. doi: 10.1136/flgastro-2020-101493. eCollection 2021.
PubMed 35401953Caio G, Volta U, Sapone A, Leffler DA, De Giorgio R, Catassi C, Fasano A. Celiac disease: a comprehensive current review. BMC Med. 2019 Jul 23;17(1):142. doi: 10.1186/s12916-019-1380-z.
PubMed 31331324
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role Of Virtual Dietetic Interventions In Patients With Coeliac Disease
- ClinicalTrials.gov ID
- NCT07172555
- Acronym / sponsor ID
- STH22680
- Conditions
- Coeliac Disease
- Keywords
- coeliac disease, diet, webinar
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 15 Sep 2025 (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.
This clinical study is exploring whether a pre-recorded, on-demand webinar led by specialist dietitians can be as effective as traditional one-on-one appointments in helping people newly diagnosed with coeliac disease learn to follow a gluten-free diet. Coeliac disease is a serious, life-long condition where eating even tiny amounts of gluten, a substance found in wheat, barley, and rye, can cause damaging symptoms and long-term health problems. The only current treatment is sticking to a strict gluten-free diet, which can be difficult without proper support and guidance from dietitians.
The number of people being diagnosed with coeliac disease in the UK is growing, and this is placing extra pressure on NHS dietetic services, which are already stretched. Many patients currently face long waits or do not get any dietetic support at all. To address this, the research team at Sheffield Teaching Hospitals has developed an on-demand, first-appointment webinar to provide immediate access to trusted dietary information, with the aim of improving patient care and saving NHS resources.
In this study, adults newly diagnosed with coeliac disease at Sheffield Teaching Hospitals will be asked to join one of two groups: one group will receive their first dietitian appointment through the new on-demand webinar, while the other group will have a traditional face-to-face or phone appointment with a dietitian. Both groups will complete short questionnaires to measure their knowledge about the gluten-free diet, their symptoms, how well they are following the diet, and their quality of life, both before and after receiving their dietary support, and again after six months. Blood tests will also be used to monitor health markers.
The main goal of the research is to find out if the first-appointment webinar is just as effective as traditional appointments in helping patients understand and follow a gluten-free diet, feel satisfied with the support they receive, and achieve good health outcomes. If the study shows that the webinar approach is as good as traditional care, it could mean quicker, easier, and more consistent access to essential dietary support for people with coeliac disease, both locally and across the UK.
Hypothesis:
The study hypothesis is that a dietitian-led, on-demand, pre-recorded webinar for a first appointment is as effective as traditional one-to-one consultations (face-to-face or by phone) in helping newly diagnosed coeliac patients achieve the same standard health outcomes, dietary knowledge, and satisfaction with care.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Dietetic First-Appointment Webinar for Coeliac Disease | Experimental | Other: Virtual Dietetic First-Appointment Webinar for Coeliac DiseaseParticipants allocated to this arm will receive a pre-recorded, dietitian-led "first appointment" webinar designed specifically for adults newly diagnosed with coeliac disease. The webinar will provide comprehensive education on the gluten-free diet, approaches to avoid cross-contamination, and strategies for nutritional adequacy. The intervention allows participants to watch and re-watch the webinar at their convenience. All participants will undergo baseline assessments and will complete knowledge and satisfaction questionnaires immediately post-intervention, with follow-up clinical and patient-reported outcomes collected at 6 months. |
| Standard Dietetic Consultation (Face-to-Face or Telephone) | Active comparator | Other: Standard Dietetic Consultation (Face-to-Face or Telephone)Participants in this group are allocated to receive the existing standard of care: an individual appointment with a specialist dietitian, delivered either in person (face-to-face) or by telephone. During the appointment, the dietitian provides a comprehensive overview of the gluten-free diet, strategies for avoiding cross-contamination, and advice on nutritional adequacy. As in the experimental arm, baseline assessment and validated questionnaires are administered pre- and post-intervention, with follow-up at 6 months to collect clinical, adherence, satisfaction, and quality of life data for direct comparison with the on-demand webinar intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 years and over with serology- or biopsy-proven coeliac disease.
Key exclusion criteria (1 listed)
- Patients under the age of 18 years. Patients unable to provide written informed consent. Patients who are unable to understand or speak English. Patients unable to access digital resources. Poly-diagnosis that requires additional nutritional intervention (i.e. Diabetes or Inflammatory Bowel Disease).
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 |
|---|---|---|
| Virtual Dietetic First-Appointment Webinar for Coeliac DiseaseThis intervention is a dietitian-led, pre-recorded on-demand webinar specifically designed for adults who have been newly diagnosed with coeliac disease. It acts as a patient's first formal dietetic appointment after diagnosis and provides comprehensive education about coeliac disease and the strict gluten-free diet required for its management. Unlike traditional approaches, which rely on face-to-face or telephone appointments with a dietitian-and which often involve significant waiting times-the webinar is available immediately online, allowing patients to access trusted, specialist information at their own pace and convenience, including the opportunity to re-watch as needed | Other | Virtual Dietetic First-Appointment Webinar for Coeliac Disease |
| Standard Dietetic Consultation (Face-to-Face or Telephone)Participants in this group are allocated to receive the existing standard of care: an individual appointment with a specialist dietitian, delivered either in person (face-to-face) or by telephone. During the appointment, the dietitian provides a comprehensive overview of the gluten-free diet, strategies for avoiding cross-contamination, and advice on nutritional adequacy. As in the experimental arm, baseline assessment and validated questionnaires are administered pre- and post-intervention, with follow-up at 6 months to collect clinical, adherence, satisfaction, and quality of life data for direct comparison with the on-demand webinar intervention. | Other | Standard Dietetic Consultation (Face-to-Face or Telephone) |
Primary outcome
Change in Knowledge of Gluten-Free Diet
Time frame: Baseline (pre-intervention), immediately post-intervention, and at 6-month follow-up.
Assessed using the Coeliac Disease and Gluten-Free Diet Quiz, a structured and previously validated questionnaire administered at baseline, immediately post-intervention, and at 6 months. This tool evaluates patient knowledge related to coeliac disease and the gluten-free diet requirements for effective disease management. Scores pre- and post-intervention (webinar or standard care) will be compared to determine the educational impact of each modality.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 31977451Rej A, Trott N, Kurien M, Branchi F, Richman E, Subramanian S, Sanders DS. Is Peer Support in Group Clinics as Effective as Traditional Individual Appointments? The First Study in Patients With Celiac Disease. Clin Transl Gastroenterol. 2020 Jan;11(1):e00121. doi: 10.14309/ctg.0000000000000121.
- Background: PubMed 22169081Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9.
- Background: PubMed 35401953Rej A, Buckle RL, Shaw CC, Trott N, Urwin H, McGough N, Aziz I, Sanders DS. National survey evaluating the provision of gastroenterology dietetic services in England. Frontline Gastroenterol. 2020 Jun 16;12(5):380-384. doi: 10.1136/flgastro-2020-101493. eCollection 2021.
- Background: PubMed 31331324Caio G, Volta U, Sapone A, Leffler DA, De Giorgio R, Catassi C, Fasano A. Celiac disease: a comprehensive current review. BMC Med. 2019 Jul 23;17(1):142. doi: 10.1186/s12916-019-1380-z.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie published results will be made available to researchers upon reasonable request following completion of the trial and publication of the main findings. Data will be stored securely and released only with appropriate approvals, in accordance with the Data Protection Act 2018 and Sheffield Teaching Hospitals NHS Trust policies. Requests for access may come from both internal and external research collaborators, and all IPD will be stripped of direct patient identifiers prior to sharing.
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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.
Arkadeep Dhali, MBBS, MPH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Dietetic First-Appointment Webinar for Coeliac Disease and Standard Dietetic Consultation (Face-to-Face or Telephone) in people with Coeliac Disease, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 1 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David S Sanders, MBChB, MD, FRCP, FACG (0114 271 3412, david.sanders1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knowledge of Gluten-Free Diet (time frame: Baseline (pre-intervention), immediately post-intervention, and at 6-month follow-up.). 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 NCT07172555, which also lists 4 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 18 Mar 2026.