Trial name or title	Design of fit for 2 study: the effects of an exercise program on insulin sensitivity and plasma glucose levels in pregnant women at high risk for gestational diabetes
Methods	Randomised controlled trial.
Participants	Location: The Netherlands. Target number of participants: 160. Inclusion criteria: between 14 and 20 weeks of pregnancy, over 18 years of age, sufficiently fluent in Dutch, being able to be moderately physically active, and willingness to give written informed consent Exclusion criteria: diagnosed with (gestational) diabetes mellitus before randomisation, hypertension (systolic pressure > 160 mmHg and/or diastolic pressure >100 mmHg), alcohol abuse (i.e. 2 glasses alcohol or more per day), drug abuse (except for incidental analgesic agents), use ofthe medication that affects insulin secretion or insulin sensitivity (antiviral, corticosteroids, antihypertensive drugs, all concomitant medication will be discussed), serious pulmonary (COPD, exercise-induced asthma), cardiac, hepatic or renal (serum creatinine < 150 mol/)impairment, malignant disease; serious mental or physical impairment i.e. preventing to understand or implement the study protocol/aim
Interventions	Intervention group: receives an exercise program twice a week in addition to usual care. The exercise program consist of aerobic and strength exercises and takes place under close supervision of a physiotherapist Control group: receives usual care given by obstetricians and midwives. Dutch midwives and obstetricians follow closely the health status of each pregnant woman and their unborn child. The 1st appointment is usually between 9th and 12th week of gestation
Outcomes	Primary maternal outcome measures are fasting plasma glucose and relative increase in insulin resistance. Primary neonatal outcome is birthweight Secondary outcome measures are maternal serum triglycerides, HDL, cholesterol and HbA1 c, maternal weight gain during pregnancy, maternal physical activity level, foetal growth. Changes in direct healthcare and non-healthcare costs and indirect non-healthcare costs are studies as well
Starting date	14 November 2008.
Contact information	Nicolette Oostdam; n.oostdam@vumc.nl
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