Trial name or title	A randomised control trial of low glycaemic index carbohydrate diet versus no dietary intervention in the prevention of recurrence of macrosomia
Methods	Randomised controlled trial. Randomisation will be achieved using computer-generated allocations in a ratio of 1:1 contained in sealed opaque envelopes
Participants	Location: the National Maternity Hospital, Dublin, Ireland. Target number of participants: 700. Inclusion: secundigravid women of reproductive age (greater than 18 years and less than 45 years) whose 1st baby was macrosomic (birthweight > 4000 gm) will be recruited at 1st booking visit from the antenatal clinic at the National Maternity Hospital Exclusion: diabetes, other medical disorders and those with poor previous pregnancy outcome
Interventions	A diet arm: will be commenced on a low glycaemic index diet from 14 weeks’ gestation to delivery under dietetic supervision A control arm: will receive no dietary intervention.
Outcomes	Primary outcomes: mean birthweight centiles and ponderal indices in each group. Outcomes will be measured at 14 weeks, 28 weeks, 34 weeks, at birth and 3 months postpartum Secondary outcomes: maternal weight gain in pregnancy; urinary metabolimics; cord insulin, leptin and IGF-1; placental weight, villous and vascular development. Outcomes will be measured at 14 weeks, 28 weeks, 34 weeks, at birth and 3 months postpartum
Starting date	Anticipated start date, 01/01/2007.
Contact information	Professor Fionnuala McAuliffe; fmcauliffe@nmh.ie UCD Obstetrics & Gynaecology, UCD School of Medicine and Medical Science, University College Dublin, National Maternity Hospital, Holles Street
Notes	Publication protocol in “Walsh J, Mahony R, Foley M, McAuliffe F. A randomised control trial of low glycaemic index carbohydrate diet versus no dietary intervention in the prevention of recurrence of macrosomia. BMC Pregnancy and Childbirth 2010;10:16.” A pilot study of feasibility of the trial was published in the abstract of poster presentation of Mahony 2008