The Role Of Virtual Dietetic Interventions In Patients With Coeliac Disease
Phase: NA
Conditions: Coeliac Disease
Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

 
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TITLE 
The Role Of Virtual Dietetic Interventions In Patients With Coeliac Disease 
 
SHORT STUDY TITLE 
 Virtual Dietetic Interventions in Patients with Coeliac 
 
 
 
 
IRAS Number: 
 
 
340526 
 
Sponsor Name and Address:  
Sheffield Teaching Hospitals NHS Trust,  
 
 
 
 
 
 
8 Beech Hill Road, Sheffield, S10 2SB 
 
Sponsor’s Reference: 
 
STH22680 
 
Directorate:  
 
 
Gastroenterology 
 
 
 
 
 
 

 
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Contents 
1 
KEY STUDY CONTACTS .................................................................................................................... 3 
2 
STUDY SUMMARY ............................................................................................................................ 4 
2.1 
RESEARCH QUESTION ............................................................................................................. 4 
3 
STUDY SPONSOR ............................................................................................................................ 5 
4 
BACKGROUND ................................................................................................................................ 5 
5 
RATIONALE ...................................................................................................................................... 5 
6 
RESEARCH AIMS ............................................................................................................................. 6 
6.1 
Objectives ................................................................................................................................ 6 
6.2 
Outcomes ................................................................................................................................ 6 
7 
STUDY DESIGN AND METHODS OF DATA COLLECTION AND DATA ANALYSIS ................................ 6 
8 
STUDY SETTING ............................................................................................................................... 9 
9 
SAMPLE AND RECRUITMENT ........................................................................................................... 9 
9.1 
Eligibility Criteria ...................................................................................................................... 9 
9.1.1 
Inclusion criteria ................................................................................................................. 9 
9.1.2 
Exclusion criteria ................................................................................................................ 9 
9.2 
Sample size .............................................................................................................................. 9 
9.3 
Recruitment, sample identification and consent.................................................................... 10 
10 ETHICAL AND REGULATORY CONSIDERATIONS ........................................................................... 10 
10.1 
Research Ethics Committee (REC) and other Regulatory review & reports ............................. 10 
10.2 
Patient & Public Involvement.................................................................................................. 10 
10.3 
Protocol compliance .............................................................................................................. 10 
10.4 
Data protection and patient confidentiality ............................................................................ 10 
10.5 
Data Custodian ...................................................................................................................... 11 
10.6 
End of Trial definition and access to the final study dataset ................................................... 11 
11 DISSEMINATION POLICY ............................................................................................................... 11 
12 STUDY MANAGEMENT, MAINTENANCE, AND FINANCE ................................................................ 11 
13 EXPERTISE OF THE STUDY TEAM: .................................................................................................. 12 
14 STATISTICAL OPINION: .................................................................................................................. 12 
15 REFERENCES ................................................................................................................................... 12 
16. APPENDICES ................................................................................................................................ 13 
16.1 Appendix 1 - Amendment History ............................................................................................ 13 
 

 
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1 
KEY STUDY CONTACTS 
Chief Investigator 
Professor David S. Sanders  
david.sanders1@nhs.net  
Study Co-Ordinator 
Nick Trott 
nick.trott@nhs.net 
Data Custodian 
Professor David S. Sanders 
Key Protocol Contributors 
Professor David S. Sanders 
Nick Trott 
Dr Arka Dhali 
 
Sponsor 
Sheffield Teaching Hospitals, NHS Foundation Trust, Trust 
Headquarters, 8 Beech Hill Road, Sheffield, S10 2SB  
sth.researchadministration@nhs.net 
Sponsor Representative 
Ms Jemima Clarke 
Sponsor Contact 
sth.researchadministration@nhs.net 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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2 
STUDY SUMMARY 
Study Title 
The role of virtual dietetic interventions in patients with coeliac 
disease 
Internal Ref./ Short 
Title 
Coeliac disease dietetic webinars 
Study Design 
Prospective cohort study 
Study Participants 
Adult patients (≥18 years old) with coeliac disease referred for 
dietetic implementation of a gluten-free diet  
Follow Up Duration 
6 months 
Research Aims 
1. To develop a “first appointment” on-demand dietetic webinar 
(ODW) for patients with newly diagnosed coeliac disease.  
2. To assess the effectiveness and patients’ acceptability of online 
dietary advice. 
3. To compare the ODW to the current standard of care face-to-face 
or telephone appointments. 
 
 
2.1 RESEARCH QUESTION  
Is a ‘first-appointment’ pre-recorded, on demand webinar equivalent to traditional one-to-one 
dietetic consultations in relation to standard clinical outcomes in coeliac disease 
 
2.2 ABSTRACT   
1. Both the incidence and prevalence of coeliac disease is increasing - however only 
approximately 36% of patients are diagnosed in the UK. 
2. Increased diagnosis in the coming years will likely lead to difficulties with service 
provision. 
3. Research has highlighted a lack of specialised dietetic services in England who are 
central in managing this condition effectively. 
4. We have previously shown that ‘in-person’ group sessions can help to effectively 
manage this caseload and free up 50% of dietetic time. 
5. On demand ‘1st-appointment’ webinars are another novel delivery modality for this 
patient cohort that are yet to be studied. 
6. Potential additional benefits of on demand webinars are: 
a. They can be rolled out nationally with educational delivery from specialist 
centres. 
b. Patients can consolidate their knowledge by re-watching the webinars at their 
convenience. 
c. It would likely offer an additional time saving in relation to dietitian resources 
that could be redirected to more complex cases - including the increase of 
refractory or non-responsive disease. 
 

 
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3 
STUDY SPONSOR 
Sheffield Teaching Hospitals NHS Foundation Trust. Responsible for sponsor duties in 
accordance with the UK Policy Framework for Health and Social Care Research will be the Data 
Controller. 
 
4 
BACKGROUND 
Coeliac Disease (CD) affects 1% (approximately 530,000) of all adults in the UK, currently only 
36% of sufferers are diagnosed. This condition affects multiple organ systems, increasing the 
prevalence of vitamin and mineral deficiencies, other autoimmune disorders, osteoporosis and 
gastrointestinal malignancies. The cornerstone for treatment is the Gluten Free Diet (GFD) 
which is delivered by Dietitians across the UK. Approximately 12,000 newly diagnosed patients 
with CD are diagnosed annually. The diet can be difficult to follow without appropriate dietetic 
support, even a small quantity of gluten (<1 gram) inadvertently ingested can cause symptoms 
and inflammation1. 
Best practice indicates that patients should have one to one consultations with a dietitian at 
their first appointment and given a broad educational overview of the GFD. However, NHS 
dietetic services in the UK are underfunded and as a result patients are either often not seen 
(~40%) or given a minimum of 6 weeks to wait after their diagnosis has been confirmed by a 
doctor 2. 
Discussions with patient representatives have indicated they have a strong preference for 
immediate access to dietetic education and support post-diagnosis. This would help reduce the 
possibility of them accessing contradictory or inappropriate dietary information. In particular 
the patient group supported the premise of an interactive dietetic service rather than a didactic 
seminar. Patients highlighted a desire to have more than a generic first consultation 2. 
For this reason, the use of a dietetic-led, pre-recorded, On-Demand Webinar (ODW) has the 
potential to offer an immediate first-patient consultation which could improve patient equity of 
access, standardise dietetic care and have significant cost-savings to the NHS and patients. 
5 
RATIONALE 
Approximately 12,000 patients with CD are diagnosed annually in the UK and the only current 
treatment is a strict lifelong Gluten Free Diet (GFD) delivered by dietitians. The GFD is difficult 
to follow without dietetic support; small quantities of gluten can cause inflammation. NHS 
Dietetic services in the UK are underfunded and national surveys indicate approximately 40% of 
patients with CD in the UK may receive no dietetic input. 
National guidelines dictate all patients with CD should receive an overview of the GFD from a 
dietitian at their initial appointment. Through the use of a dietetic-led ODW covering the GFD 
there is an opportunity to deliver the first appointment using digital technology. ODWs are 
increasingly applied in healthcare settings negating the need for hospital appointments, 

 
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reducing time and financial costs to patients. The viability and patient acceptability of a ODW in 
CD has not been investigated. 
6 
RESEARCH AIMS 
6.1 Objectives 
I. 
To develop a ‘first appointment’ ODW for patients with newly diagnosed CD. 
II. 
To assess the effectiveness and patients’ acceptability of online dietary advice. 
III. 
To compare the ODW to the current standard of care face-to-face or telephone 
appointments. 
6.2 Outcomes 
IV. 
Change in patient knowledge of the GFD pre- and post-intervention, assessed using 
a structured questionnaire based on previously validated tools. 
V. 
Adherence to the GFD at follow-up, assessed using the Biagi adherence score and 
standardised dietetic evaluation. 
VI. 
Clinical outcomes, including coeliac serology and haematinic markers (B12, folate, 
ferritin, vitamin D). 
VII. 
Patient-reported acceptability and satisfaction, assessed using a purpose-designed 
questionnaire based on existing validated frameworks. 
VIII. 
Quality of life outcomes, assessed using the EQ-5D questionnaire 
IX. 
Comparison of these outcomes between patients receiving the ODW and those 
receiving standard care. 
7 
STUDY DESIGN AND METHODS OF DATA COLLECTION AND DATA ANALYSIS 
This is a single-centre prospective study. Adults newly diagnosed with coeliac disease are 
screened and invited to participate following informed consent. Sixty patients are alternately 
allocated into two equal groups: one receiving a dietitian-led, pre-recorded ODW, and the other 
receiving standard of care (via face-to-face or telephone) consultation. Both groups undergo 
identical baseline assessments, including clinical measures, medical history, and validated 
questionnaires. Following their respective interventions, participants complete a knowledge 
questionnaire and satisfaction form. At six months, outcomes including clinical outcomes, 
symptom burden, quality of life, and adherence to the gluten-free diet are (re)assessed, allowing 
comparison of the ODW’s effectiveness and acceptability against standard care. This pragmatic 
design reflects both clinical realities and patient preferences, aiming to inform scalable, 
digitally delivered first-line dietary support for coeliac disease.  
 
 
 
 
 

 
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The flow diagram below illustrates the study design: 
 
 
 

 
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The following data will be collected:  
Type of Data 
Purpose 
When 
Completed 
Completed 
by 
Basic patient 
demographics 
To collect key characteristics 
(age, sex, height, weight, BMI) 
Pre-intervention 
and follow-up 
(for 
anthropometrics) 
Patients / PI 
Medical history 
To identify relevant 
comorbidities and clinical 
background 
Pre-intervention 
PI 
Histological, laboratory 
data collected as part 
of standard clinical 
care 
To confirm coeliac diagnosis 
and assess response to the 
GFD 
Pre-intervention 
and follow-up 
PI 
Standardised 
dietetic 
evaluation 
of 
GFD 
adherence 
To assess dietary intake, 
understanding of gluten 
sources, risk of cross-
contamination, nutrition 
adequacy, and confidence with 
the GFD 
At follow-up 
PI 
 
Questionnaires 
Purpose 
When 
Completed 
Completed 
by 
Coeliac Disease and 
Gluten-Free Diet Quiz 
To assess patient knowledge 
about Coeliac disease and the 
GFD Pre-post Intervention and 
follow-up. 
Pre-intervention, 
post-
intervention, and 
at follow-up 
Patients 
Overall Symptoms 
Questionnaire 
To evaluate symptom burden 
Pre-intervention 
and at follow-up 
Patients 
EQ-5D Quality of Life 
Questionnaire 
To assess overall health status 
and quality of life 
Pre-intervention 
and at follow-up 
Patients 
Biagi Gluten-Free Diet 
Adherence Score 
To evaluate adherence to the 
gluten-free diet. 
At follow-up 
Patients 
Acceptability 
Evaluation Satisfaction 
Form 
To evaluate satisfaction and 
acceptability of the dietetic 
education provided (both ODW 
and standard care) 
Post-
intervention 
Patients 
 

 
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8 
STUDY SETTING 
The gastroenterology directorate at STH is a large, clinically and research active directorate with 
a very significant outpatient and inpatient activity. STH is one of only a handful of centres 
nationwide that offers tertiary level care for endoscopy and is one of only 2 centres in the UK, 
and one of 21 centres globally to be recognised as a World Endoscopy Organisation Centre of 
Excellence. The Sheffield Centre has the largest number of patients with coeliac disease in the 
UK (more than 2500) who have been diagnosed and managed over 20 years. Referrals come 
from across the UK and as a result the unit is now the designated NHS England National Centre 
for Refractory Coeliac Disease. Research governance support is provided by the STH Clinical 
Research & Innovation Office. 
9 
SAMPLE AND RECRUITMENT 
 
9.1 Eligibility Criteria 
9.1.1 Inclusion criteria 
Patients aged 18 years and over with serology- or biopsy-proven coeliac disease. 
9.1.2 Exclusion criteria 
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). 
 
9.2 Sample size 
 
Research by Sim and Lewis (2012) recommends a sample size of at least 30 participants per 
group in order to estimate the pooled standard deviation of the outcome, with a reasonable 
degree of precision. In our previous real-world study (2015–2016) investigating the efficiency of 
group clinics for coeliac disease, we recruited 60 patients over an 18-month period. This was 
out of a possible 100 and equates to a 60% recruitment rate over that period. Dietary 
intervention studies tend to have higher uptake and patient participation than pharmacological 
studies. Since that trial, our centre has experienced a year-on-year increase in referrals for 
newly diagnosed coeliac patients—averaging 150 patients referred per annum. It was therefore 
felt that 60 participants would provide sufficient data to meet the study’s aims and objectives. 
 

 
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9.3 Recruitment, sample identification and consent 
 
Eligible patients aged 18 years and over with serology- or biopsy-proven coeliac disease referred 
from primary or secondary care for implementation of GFD will be offered the chance to 
participate in the study. If in agreement, informed written consent will be obtained from the 
patient. All participants will be informed they can withdraw consent and their involvement in the 
trial at any point and their data will not be used in any part of the analysis. The participants will 
be alternately allocated to either the webinar or a one-to-one appointment so that 30 
participants are consecutively allocated into either group 1 or group 2. 
Quality Control: 
The study will be monitored as per STH clinical research and innovation office guidelines 
Timescales: 
Recruitment, data analysis, publication and disseminating of the results is estimated at 24 
months. These timescales are based on our previous work (see reference 4). 
10 ETHICAL AND REGULATORY CONSIDERATIONS 
10.1 Research Ethics Committee (REC) and other Regulatory review & reports 
A favourable opinion will be sought from a REC for the study protocol. Amendments to the 
protocol will be submitted via the IRAS portal, through the usual process. 
 
10.2 Patient & Public Involvement 
From previous PPI events we have held, patients felt it was beneficial to see a dietitian on 
diagnosis rather than wait a long time for a referral. Their advice was based on the fact that they 
found it difficult to know what information to trust from current internet sources. We plan to 
involve patient representatives in shaping how study findings are shared, including through 
Sheffield-based Coeliac UK groups and wider national engagement. We’ll also engage with 
peer-to-peer communities via podcasts and social media platforms—both the PI and the 
Sheffield Gastroenterology team have active online presences, with a combined following of 
over 5,000, offering a direct route to reach patients and the wider coeliac community. 
 
10.3 Protocol compliance 
We will work closely with the STH Clinical Research & Innovation Office to ensure our research 
meets appropriate research governance standards 
 
10.4 Data protection and patient confidentiality 
This research project will follow the standard governance procedures that apply to all STH 
research projects (including Information Governance, Clinical Director approval, the Clinical 
Research and Innovation Office approval process). 

 
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The case report forms, source data and Investigator Site File will be stored in a designated room 
that is secured by a locked door. Electronic data will be stored on STH PCs only, which are 
encrypted, networked and password protected. 
The data will be stored for 10 years. 
10.5 Data Custodian 
Professor David Sanders (Consultant Gastroenterologist)  
Email: David.sanders1@nhs.net 
Work phone: 01142713412 
Academic Unit of Gastroenterology, Glossop Rd, Broomhall, Sheffield S10 2JF 
 
10.6 End of Trial definition and access to the final study dataset  
The declaration of end of trial will be submitted once the data analysis has been completed and 
publications have been drafted.  
Requests for access to the data will come primarily from within the Gastroenterology and 
surgical teams of doctors and clinicians, including partners from the University of Sheffield. In 
some cases, the data may be used by medical trainees such as Specialist Registrars/Research 
Fellows and BMedSci students who undertake research projects as part of their training at the 
Academic Unit of Gastroenterology at STH. Additionally, there may be some requests for access 
to data from other staff in other directorates of Sheffield Teaching Hospitals. Finally, some data 
may on occasion be requested from external researchers - this may be as part of collaborative 
research activity between STH and other NHS organisations, academia or industry with 
researchers based worldwide. In all cases, data will be de-identified before any data are sent to 
researchers and before any research is carried out. All patient information will be managed in 
accordance with the Data Protection Act 2018, and local approval will be obtained from the STH 
Information Governance Officer/Caldicott Guardian, and R&D Department. 
 
11 DISSEMINATION POLICY 
Results of the study will be collated as scientific papers for submission to peer reviewed 
journals. Data will also be submitted for presentation at local, national and international patient 
and scientific meetings. Equally the results will be shared with patient charity groups including 
Coeliac UK (national patient charity, who have endorsed the webinar). 
 
12 STUDY MANAGEMENT, MAINTENANCE, AND FINANCE 
The research project would be subject to standard policies and procedures laid down by STH. 
The webinar is funded from the research account of Professor David Sanders.  

 
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Intellectual Property: None. 
Taking the project forward: Should it be successful, this study has the potential to change 
current clinical practice. Findings could inform the adoption of on-demand webinars as a 
standard first-line dietetic intervention for newly diagnosed coeliac patients (particularly in 
settings with limited dietetic capacity) with the model offering potential for wider national 
implementation to improve equity of access and reduce waiting times for specialist dietary 
input. 
To support uptake, results will be disseminated at both national and international meetings and 
conferences, including our biannual National Gastroenterology Dietetics Symposium held in 
Sheffield, which is attended by over 300 dietitians and made available on demand across the 
UK and internationally. We also plan to present at the International Coeliac Disease Symposium 
(ICDS) to support global awareness of the approach. In addition, we aim to publish the findings 
in an open-access format, making them freely accessible to dietitians - particularly important 
given the lack of institutional access to academic literature within the dietetic profession. 
Should there be significant uptake of this delivery model, future research could explore health-
related and food-related quality of life in patients with coeliac disease, using the webinar as a 
platform for data collection. National adoption would offer a valuable opportunity to examine 
these aspects in a larger population through a well-powered study. 
 
13 EXPERTISE OF THE STUDY TEAM: 
Sheffield Gastroenterology Department have been the recipients of 11 Clinical Service Awards 
(10 national and 1 international) and 9 Clinical Research Awards (6 National & 3 International) 
in the last decade. The department has published many papers in high impact journals. In 
relation to this particular study we have already published in the area successfully (Ref 4) and 
are now looking to build on this previous publication and extend the data collection and 
research to on demand webinars as a novel delivery modality for gluten-free patient education. 
14 STATISTICAL OPINION: 
All data will be analysed using SPSS version 29 (International Business Machines, Armonk, NY). 
Data will be summarised using descriptive statistics, including counts and percentages for 
categorical data and mean ± SD for continuous data. Paired t-tests will used to compare 
continuous data within groups, with the independent t test to compare continuous data 
between groups. Comparison between categorical data between both groups will be performed 
using C2 testing. Statistical significance will be considered when P < 0.05. 
15 REFERENCES 
1. 
Caio, G. et al. Celiac disease: a comprehensive current review. BMC Med. 17, 142 (2019). 
2. 
Rej, A. et al. National survey evaluating the provision of gastroenterology dietetic services 

 
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in England. Frontline Gastroenterol. 12, 380–384 (2021). 
3. 
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. 65, 301–308 
(2012). 
4. 
Rej, A. et al. Is Peer Support in Group Clinics as Effective as Traditional Individual 
Appointments? The First Study in Patients With Celiac Disease. Clin. Transl. 
Gastroenterol. 11, e00121 (2020). 
5 
Biagi, F., Andrealli, A., Bianchi, P. I., Marchese, A., Klersy, C. and Corazza, G. R. (2009) ‘A 
gluten-free diet score to evaluate dietary compliance in patients with coeliac disease’, 
British Journal of Nutrition, vol. 102, no. 6, pp. 882–887 
16. APPENDICES 
 
16.1 Appendix 1 - Amendment History 
 
Amendment 
No. 
Protocol 
version no. 
Date issued 
Author(s) of 
changes 
Details of changes made