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Paige 2

PAIGE2 – Pragmatic Pregnancy and Post Pregnancy Lifestyle Intervention for Overweight Women with Gestational Diabetes Mellitus: a Randomised Controlled Clinical Trial (Host Organisation – BHSCT)

Gestational Diabetes Mellitus (GDM), defined as high blood sugar levels during pregnancy, is an increasing health problem for both mothers and babies which affects up to 18% of pregnancies worldwide. Women with previous GDM are seven times more likely to develop future type 2 diabetes compared to women without GDM. There is good evidence outside of pregnancy that lifestyle change (diet and physical activity) can reduce the development of type 2 diabetes in people at risk, but there are many demands on a new mother, and weight gained during pregnancy is frequently not lost afterwards. The National Institute for Health and Care Excellence (NICE) recently highlighted that further research is urgent in this area. 

We have recently completed a pilot postnatal lifestyle program for overweight women with previous GDM (PAIGE) which showed a significant 3.9 kgs weight reduction at six months among 31 women in PAIGE compared with 29 women who received usual care, supporting its clinical usefulness. 

Based on feedback from the pilot study, we are now planning a definitive trial (PAIGE2) involving larger numbers of subjects, across six cross-border regions (Royal Victoria Hospital, Ulster and Antrim Area Hospitals in Northern Ireland and Letterkenny, Sligo and Drogheda Hospitals in the Republic of Ireland). 

This research is a multi-component, family-based intervention customised to the postnatal period. The primary outcome is weight reduction at 12 months. If the results of PAIGE2 are positive, they could have major implications for population health and be readily translated into routine clinical practice. 

 

Lead Contact:

Professor David McCance, Belfast Health and Social Care Trust

David.mccance@belfasttrust.hscni.net

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