The HEALTHY study: Healthy Eating, Exercise And Lifestyle Trial for pregnant women for the control of fasting blood glucose

Mise à jour : Il y a 4 ans
Référence : ISRCTN31045925

Femme Homme

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Background and study aims Gestational Diabetes Mellitus (GDM) is diabetes that is diagnosed during pregnancy, and affects 3-6% of women who deliver a baby in Ireland. GDM has a serious impact on the woman and her baby. She is more likely to require induction of labour or a caesarean section, and the diagnosis has a 7-fold increase in the risk of developing type 2 diabetes mellitus. Potential complications for the baby include stillbirth, malformations at birth, excessive accumulation of fat, low blood sugar after birth and an increased risk of childhood obesity. GDM is now diagnosed more often in Ireland because of stricter guidelines and prompt screening, which is based on risk factors. The mother may get GDM due to family history, previously delivering a large baby, and maternal obesity. Arguably, obesity is the most important risk factor because it is common and potentially modifiable. About one in six women booking for antenatal care in Ireland today is obese which places them at high risk of GDM. The purpose of this research is to find out whether a programme of intensive, supervised exercise classes, providing information on diet and lifestyle, starting early in the second trimester, will improve an obese woman’s fasting glucose levels at 24-28 weeks of pregnancy. Who can participate? Overweight women attending the hospital for their first visit between 10 and 17 weeks of pregnancy, will be invited to take part in this study. What does the study involve? Participants will be randomly allocated to one of two groups: intervention or non-intervention. The intervention group will be asked to attend three exercise classes per week, and will continue receiving standard antenatal care. The non-intervention group will continue their pregnancy receiving standard antenatal care alone. Assessments of the pregnant woman and her baby (measurements of weight and body composition, blood tests, and lifestyle and quality of life questionnaires) will be performed at 24-28 weeks and 35-38 weeks of pregnancy, and at 6 weeks after childbirth. What are the possible benefits and risks of participating? Exercise in pregnancy has been shown to be safe. We will coach participants during classes on how intensely, how often, and what exercise they should be doing. Benefits to exercising during pregnancy are both physical and psychological. Where is the study run from? The study is run from the Coombe Women and Infants University Hospital, Ireland. When is the study starting and how long is it expected to run for? It is anticipated that recruitment will start towards the end of 2013. Participants will be enrolled in the study from 10-17 weeks of pregnancy to 6 weeks after giving birth; however, the study will extend beyond this as we intend to follow the participants and their infants’ health over a longer period. Who is funding the study? The Coombe Women and Infants University Hospital (CWIUH) (Ireland) and University College Dublin (UCD) (Ireland) are funding the study. Who is the main contact? Prof. Michael J Turner [email protected]


Critère d'inclusion

  • Gestational diabetes, obesity in pregnancy

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