Trial name or title	Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: a randomised trial
Methods	Randomised controlled trial.
Participants	Location: Australia. Target sample size: 2574. Inclusion criteria: pregnant women with a singleton, live gestation between 10-20 weeks who are obese or overweight (defined as a BMI greater that 25kg/m2) Exclusion criteria: women with multiple pregnancy, or type 1 or type 2 diabetes diagnosed prior to pregnancy. There is no age range criteria for this trial
Interventions	Women will be randomised to the dietary and lifestyle advice group or the standard care group Dietary and lifestyle advice group will receive a comprehensive intervention to limit weight gain in pregnancy that includes a combination of dietary, exercise and behavioural strategies Standard care group will continue to receive their pregnancy care according to local hospital guidelines, which does not currently include routine provision of dietary, lifestyle and behavioural advice)
Outcomes	Primary outcome: infant large-for-gestational age at birth (defined as birthweight > 90th centile for gestational age) Secondary outcomes: adverse outcomes for the infant including preterm birth, adverse outcomes for the women, maternal quality of life and emotional well being and costs of health care
Starting date	1/02/2008.
Contact information	Dr Jodie Dodd; jodie.dodd@adelaide.du.au University of Adelaide, Obstetrics & Gynaecology Women’s and Children’s Hospital Level 1, Queen Victoria Building 72 King William Road North Adelaide SA 5006
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