Extrait

Background and study aims Up to 15% of pregnant women develop a temporary type of diabetes during pregnancy called gestational diabetes mellitus (GDM). In GDM, women develop high blood sugar levels as the body is unable to produce enough insulin (a hormone that helps convert sugar into stored energy). GDM is associated with increased risks for mother and baby including increased risk of later life diabetes for the mother. Research shows that structured education programmes can help people to lower their risk of developing cardiovascular disease (disease of the heart and blood vessels) and so can be beneficial for a patient’s future health and for health care professionals. The aim of the study is to develop and implement face-to-face and online lifestyle education programme to meet the needs of women with a history of gestational diabetes. Who can participate? Women who are up to 36 weeks into their pregnancy who have been diagnosed with gestational diabetes. What does the study involve? All participants attend an initial study visit where blood pressure, body measurements and blood samples are taken to measure cholesterol and to find out whether they have diabetes or are likely to develop type 2 diabetes, as well as completing questionnaires about diet and exercise. Participants are then randomly allocated to one of two groups. Those in the first group are given an information leaflet after the birth of the baby. Those in the second group attend two three-hour education sessions spaced approximately two weeks apart. These participants are also given access to an interactive website, which encourages healthy lifestyle choices, such as through diet and exercise advice. All women are asked to wear an activity monitor for eight days before, during (six months) and after the study (12 months) to record their activity levels. At the start of the study and then again after six and 12 months participants complete a number of questionnaires to measure their wellbeing and provide blood samples to assess blood sugar and cholesterol. What are the possible benefits and risks of participating? All women taking part will benefit from a free health assessment and physical activity advice as well as information on general fitness levels. There is a small risk of pain or bruising when blood samples are taken. Where is the study run from? 1. Leicester General Hospital (UK) 2. Leicester Royal Infirmary (UK) 3. George Eliot Hospital NHS Trust (UK) When is the study starting and how long is it expected to run for? March 2015 to December 2018 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Ms Carol Liptrot [email protected]

Critère d'inclusion

• Specialty: Reproductive health and childbirth, Primary sub-specialty: Maternal/ Fetal medicine; UKCRC code/ Disease: Reproductive Health and Childbirth/ Other maternal disorders predominantly related to pregnancy

Liens

• isrctn