PostnAtal lifestyle Intervention programme for overweight women with previous GEstational diabetes mellitus (PAIGE)

Belfast Health and Social Care Trust (UK)0 个研究点目标入组 100 人开始时间: 2013年6月14日最近更新: 2019年2月11日

适应症

试验速览

•1. Aged 18 years or older
•2. History of gestational diabetes mellitus in last pregnancy. The definition of GDM will be according to the new International Association of the Diabetes in Pregnancy Study Groups (IADPSG) consensus criteria (7), following a 75g oral glucose tolerance test (OGTT) (fasting glucose =5.1 mmol/l or 1h plasma glucose = 10 mmol/l or 2h plasma glucose =8.5 mmol/l).
•3. Body mass index (BMI) = 25 kg/m2 at booking (if less than 16 weeks, otherwise based on reported pre pregnancy weight) and BMI = 25 kg/m2 at their postnatal OGTT visit. A BMI equivalent to 25 kg/m2 will be used for non Caucasian subjects.
•4. Normal or impaired glucose tolerance or impaired fasting glucose (IFG/IGT) on postnatal glucose tolerance testing.
•5. Mothers will be encouraged to continue to breast feed. The aim will be to recruit mothers who are not planning a further pregnancy in the next 6 months.

•1. Pregnancy outcome resulting in an anomaly or still birth
•2. History of diabetes outside pregnancy or diagnosis of diabetes on the postnatal OGTT
•3. Heart, liver, or chronic renal disease
•4. Medications that adversely affect glucose tolerance (e.g. steroids)
•5. Contraindications to participating in moderate physical activity
•6. Moderate/severe depressive illness
•7. Excess alcohol consumption
•8. Planning another pregnancy in the next 6 months
•9. Taking part in another research study
•10. Inability to adequately understand verbal explanations or written information given in English, or who have special communication needs
•11. Already attending a CWMO
•NB: Women will not know if they have a diagnosis of diabetes outside pregnancy until several days after the OGTT appointment (visit 1). Women who are diagnosed with persisting diabetes following the postnatal OGTT will be contacted by their diabetes care team for follow up and will be excluded from the study post randomisation.

发起方

Belfast Health and Social Care Trust (UK)