MERIT - Mediterranean diet for prevention of type 2 diabetes
Research type
Research Study
Full title
Prevention of progression to type 2 diabetes in women with gestational diabetes: A feasibility study for a randomised trial on a Mediterranean diet
IRAS ID
255208
Contact name
Shakila Thangaratinam
Contact email
Sponsor organisation
Queen Mary University of London
ISRCTN Number
ISRCTN40582975
Duration of Study in the UK
1 years, 8 months, 1 days
Research summary
A single site, feasibility study of a Mediterranean diet post delivery to prevent type 2 diabetes in women diagnosed with gestational diabetes in pregnancy.
The study will be conducted at Barts Health NHS Trust. Participants will be consented towards the end of their antenatal pathway and given the intervention in the postnatal period, from their first postnatal appointment until 1 year after childbirth. We will recruit 65 women to the dietary intervention stage of the study; to account for attrition between consent and start of the intervention, we may need to consent around 90 women. Women above the age of 16 who have been diagnosed with gestational diabetes in pregnancy and are taking insulin or metformin are eligible. They will be provided with nuts and olive oil, which are part of the Mediterranean diet, for the duration of their trial participation, and will be given access to a mobile health app.
During their participation, women will receive regular support and advice from a trained health coach, both face-to-face and via the mobile app to discuss their progress with their diet goals. They can also use the app to interact with other women in the trial through a discussion forum.
Participants will be asked to attend 3 hospital visits to assess their dietary habits, adverse events and check for type 2 diabetes.
There will also be a qualitative part of the study, where acceptability of the study, views of the diet intervention and potential barriers to participation will be explored through interviews with a proportion of participants.
The main aim of the study is to test the acceptability and feasibility of a dietary intervention to women after childbirth, with a view to inform a successful future large scale trial of the effectiveness of the Mediterranean diet in preventing type 2 diabetes.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0064
Date of REC Opinion
25 Jan 2019
REC opinion
Favourable Opinion