Extrait

Background and study aims Gestational diabetes mellitus (GDM) is a type of diabetes that affects women during pregnancy. Women affected by GDM are at increased risk of developing type 2 diabetes later in life. This study will assess the effects of an intensive lifestyle intervention programme, Croí MyAction, on reducing the risks of developing type 2 diabetes amongst women with previous GDM. Who can participate? Women in the western regions of Ireland with previous GDM and continued risk of developing type 2 diabetes. What does the study involve? Participants will be randomly allocated to either the intervention group or the control group. The control group will receive usual health care, which includes standard written information on diet and lifestyle changes recommended for reducing the risk of developing type 2 diabetes, and continue with their regular health care arrangements, visiting their family doctors if required. The intervention group will receive usual health care as per the control group and will also be invited to attend the MyAction programme for 2.5 hours once per week for up to 16 weeks. Each MyAction session will include a review of individual health goals, a group exercise session and a group information session on key health topics. Weight and blood pressure will also be regularly monitored. All women will be invited back for 1-year follow-up tests to evaluate the effects of the MyAction programme. Participants will also be interviewed to find out about their experiences of MyAction. What are the possible benefits and risks of participating? Participants who receive the MyAction intervention will benefit from an intensive lifestyle modification and medical risk factor management programme. The early results of the MyAction programme include improvements in physical activity levels, healthy eating, reductions in weight, BMI and waist circumference, and smoking cessation. The programme has also demonstrated improvements in blood sugar and lipid profiles and improved psychological health in terms of anxiety and depression. In turn, all of these benefits have the potential to reduce future risks of developing diabetes, stroke and heart disease. There are no foreseeable risks associated with this study; however, whenever blood samples are taken there is a low risk of pain or bruising at the site of the puncture and a possible, although low, risk of infection. Where is the study run from? The study is coordinated by the School of Medicine at the National University of Ireland in Galway and will be run at Croí, the West of Ireland Cardiac Foundation, University Hospital Galway. When is the study starting and how long is it expected to run for? The study is expected to begin in May/June 2012 and continue for 2.5 years. Who is funding the study? This study is funded by the Health Research Board (HRB), an Irish government agency. Who is the main contact? Professor Fidelma Dunne [email protected]

Critère d'inclusion

• Gestational diabetes mellitus

Liens

• isrctn
• ictrp