Manchester Intermittent Diet in Gestational Diabetes Acceptability Study (MIDDAS-GDM): A Two-Arm Randomised Feasibility Protocol Trial of an Intermittent Low-Energy Diet (ILED) in women with Gestational Diabetes and Obesity in Greater Manchester

Elizabeth Dapre, Basil Issa, Michelle Harvie, Ting-Li Su, Brian McMillan, Fahmy Hannah, A. Pilkington, Avni Vyas, Benjamin Evans, James Yates, Sarah Mackie, Womba Mubita, Cheryl Lombardelli

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Abstract

Introduction: The prevalence of gestational diabetes mellitus (GDM) is rising in the UK and is associated with maternal and neonatal complications. National Institute for Health and Care Excellence (NICE) guidance advises first line management with healthy eating and physical activity which is only moderately effective for achieving glycaemic targets. Approximately 30% of women require medication with metformin and/or insulin. There is currently no strong evidence base for any particular dietary regimen to improve outcomes in GDM. Intermittent low-energy diets (ILEDs) are associated with improved glycaemic control and reduced insulin resistance in type 2 diabetes (T2DM) and could be a viable option in the management of GDM. This study aims to test the safety, feasibility and acceptability of an ILED intervention amongst women with GDM compared to best National Health Service (NHS) care.

Method and analysis: We aim to recruit 48 women with GDM diagnosed between 24- 28 weeks gestation from antenatal clinics at Wythenshawe and St Mary’s hospitals, Manchester Foundation Trust, over 13 months starting in November 2022. Participants will be randomised (1:1) to ILED (2 low-energy diet days/week of 1000kcal and 5 days/week of the best NHS care healthy diet and physical activity advice) or best NHS care 7 days/week until delivery of their baby. Primary outcomes include uptake and retention of participants to the trial, and adherence to both dietary interventions. Safety outcomes will include birthweight, gestational age at delivery, neonatal hypoglycaemic episodes requiring intervention, neonatal hyperbilirubinaemia, admission to special care baby unit or neonatal intensive care unit, stillbirths, the percentage of women with hypoglycaemic episodes requiring third-party assistance, and significant maternal ketonaemia (defined as 54 Secondary outcomes will assess the fidelity of delivery of the interventions, and qualitative analysis of participant and healthcare professionals’ experiences of the diet. Exploratory outcomes include the number of women requiring metformin and/or insulin.
Original languageEnglish
JournalBMJ Open
Volume14
Issue numbere078264
DOIs
Publication statusPublished - 10 Feb 2024

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