Extrait

Background and study aims Overweight, body mass index (BMI) ≥ 24.9 kg/m2 and obesity (BMI ≥ 30 kg/m2) carry a huge health burden both on the individual and on society. Approximately 5 out of 10 women of reproductive age are either overweight or obese and this increases the risk of adverse pregnancy and fetal outcomes. For the mother, there is a higher incidence of pre- eclampsia, gestational diabetes and operative intervention at the time of delivery such as caesarean section and instrumental delivery. Problems that can arise in the baby include macrosomia [newborn with an excessive birth weight (baby > 4kg at birth)], shoulder dystocia [occurs when the baby's head has been born but one of the shoulders becomes stuck behind the mother's pelvic bone], birth injury and admission to the special care baby unit. These adverse outcomes correlate with increasing BMI, increasing gestational weight gain, higher maternal blood glucose levels and gestational diabetes. This study will examine the effect of a “healthy lifestyle package with app support” compared with routine pregnancy care on pregnancy outcomes. The “healthy lifestyle package with app support” includes a combination of a healthy diet, an exercise intervention with a smart phone application as an information and motivational source for overweight and obese women in pregnancy. The primary aim is to assess the impact of the “healthy lifestyle package with app support” on development of gestational diabetes when compared to routine antenatal care. Who can participate? Women with singleton pregnancies between 10-15 weeks gestation between the ages of 18-45 with a smartphone, and a BMI of greater than 25 kg/m2 What does the study involve? Women will be randomly assigned into two groups: an intervention group and a control group. Women in the intervention group will have standard antenatal care but will receive a particular ‘healthy lifestyle package with app support’. This package includes a combination of a healthy diet, an exercise intervention with a smart phone application as an information and motivational source for overweight and obese women in pregnancy. The control group will receive a ‘regular lifestyle package’, which will consist of standard antenatal care and general advice on weight gain according to BMI. What are the possible benefits and risks of participating? The benefits for participating are numerous. These include lower glucose levels and less gestational weight gain. The study aims to motivate and change behaviors in order to lead a healthier lifestyle, which will reduce the risk of obstetric and fetal complications as mentioned above and improve long-term health. There will also be an additional scan of the baby to assess growth at 34 weeks. Studies have shown that there are absolutely no risks to the mother or her baby from taking part in a healthy diet and sensible exercise plan during pregnancy. Where is the study run from? The study will run from the National Maternity Hospital. When is the study starting and how long is it expected to run for? The trial is starting in January 2013 and is expected to run for 2 years. Who is funding the study? National Maternity Hospital medical fund. Who is the main contact? Professor Fionnuala McAuliffe PI [email protected]

Critère d'inclusion

• Pregnancy / overweight / obesity / gestational diabetes

Liens

• isrctn
• ictrp