MIDDAS GDM
Research type
Research Study
Full title
Manchester Intermittent Diet in Gestational Diabetes Acceptability Study (MIDDAS-GDM): A randomised feasibility trial of an intermittent low energy diet (ILED) vs best NHS care in women with gestational diabetes and obesity
IRAS ID
302762
Contact name
Basil Issa
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Gestational diabetes (GDM) causes risks to mother and baby from high blood sugar, high blood pressure, induced labours and larger babies. Women often need medication to control blood sugar. Intermittent low-calorie diets(two days/week) improve blood sugar control in Type-2 diabetes and reduce the need for medication. This study aims to find out if an intermittent low-calorie diet is acceptable to women with GDM and safe and whether this diet might also improve blood sugar control in GDM. We will recruit 48 women diagnosed with GDM at 24-28 weeks pregnant. Women will be allocated randomly using 'sealed envelope' to one of two groups (24 women in each group). One group will receive best NHS care and general advice on a healthy diet, and another group will be asked to follow the intermittent low (1000 Kcal/day) calorie diet on two days of the week until delivery. Both groups receive fortnightly contact with the study dietitian. We will assess the number of participants who join, stay engaged with the study and whether they can follow the intermittent diet. The safety to the mother (e.g. mothers’ blood sugars) and baby (e.g. babies weight) will be closely monitored throughout the study. We will assess changes in weight, blood sugar, blood pressure, blood tests changes and the need for diabetes medications. We will explore the thoughts and experiences of around 10 women taking part and also health care professionals delivering the intervention via interview. This study will tell us whether intermittent diets are feasible and safe and tell us ways to improve the diet to make it more acceptable to women with GDM. It will also help us to decide whether we should proceed to a definitive study to test whether intermittent diets are better than standard current dietary management of GDM.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0119
Date of REC Opinion
2 Aug 2022
REC opinion
Further Information Favourable Opinion