Virtual Dietetic Interventions in Patients With Coeliac

NCT07172555 | Recruiting

• 1 other identifier: STH22680
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Coeliac Disease

Keywords

coeliac disease; diet; webinar

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (pre-intervention), immediately post-intervention, and at 6-month follow-up.

Study Arms (2)

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.

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.

Other: Standard Dietetic Consultation (Face-to-Face or Telephone)

Interventions

Virtual Dietetic First-Appointment Webinar for Coeliac Disease OTHER

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

Virtual Dietetic First-Appointment Webinar for Coeliac Disease

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.

Standard Dietetic Consultation (Face-to-Face or Telephone)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years and over with serology- or biopsy-proven coeliac disease.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S57AU, United Kingdom

RECRUITING

Related Publications (4)

• 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.

  PMID: 31977451 BACKGROUND

• Sim 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.

  PMID: 22169081 BACKGROUND

• Rej 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.

  PMID: 35401953 BACKGROUND

• Caio 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.

  PMID: 31331324 BACKGROUND

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

David S Sanders, MBChB, MD, FRCP, FACG

CONTACT

0114 271 3412; david.sanders1@nhs.net

Arkadeep Dhali, MBBS, MPH

CONTACT

a.dhali@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 15, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

GB (1)