Intervention to Increase Compliance to a Gluten Free Diet
Research type
Research Study
Full title
Intervention to increase compliance to a gluten free diet in patients with coeliac disease.
IRAS ID
214859
Contact name
Humayun Muhammad
Contact email
Sponsor organisation
Roehampton University
Clinicaltrials.gov Identifier
LSC 16/ 190., University of Roehampton, London
Duration of Study in the UK
1 years, 0 months, 31 days
Research summary
Coeliac disease (CD) is a disorder of the gastrointestinal system where a reaction to gluten (found in wheat and related products) leads the inflammation of the inner lining of the small bowel. This in turns leads to mal-absorption resulting in anaemia, and may lead to skin disorder, cancer and bone disease. Avoiding gluten is the only practical way to counteract this reaction. Patients with coeliac disease are offered strict Gluten free diet (GFD).
The GFD is not easy to follow and there are several compliance related issues for patients with CD. There is evidence to suggest that patients following a GFD have less disease related complications. Compliance is low in Asian patients as shown by one previous study in 2004 (Butterworth et; al). There is only one Australian study (Sainsbury and Mulan 2013) which designed and administered an intervention to increase compliance to GFD in CD.
In a previous study we conducted an interview with patients non-compliant to the GFD, information provided by the patients has informed the design of our intervention, a telephonic clinic, which is also considered cost effective. This will be the first intervention which will include ethnic minority who does not speak English, the telephonic clinic will be conducted in English and ethnic languages. Prior to the telephonic interview and up to 12 months afterwards participants will periodically receive questionnaires to evaluate the impact of the telephonic interview on compliance to the GFD.
We have identified 700 patients, in the Dudley area, who could be invited to participate in the study.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
17/EM/0056
Date of REC Opinion
22 Feb 2017
REC opinion
Further Information Favourable Opinion