Healthy Mums and Babies (HUMBA) trial 12 month follow up protocol

This is the protocol for a follow-up study of 1-year-old children and their mothers from the HUMBA Demonstration Trial, two by two factorial randomised controlled trial of a dietary intervention versus routine dietary advice, and probiotics versus placebo (double blind) in obese pregnant women.

The primary objectives of this study are to determine if at 1 year post expected delivery date whether treatment of obese pregnant women with probiotics versus placebo, and a dietary intervention versus routine dietary advice: 1) For the infant reduces risk factors for later obesity and cardio-metabolic disease, including large body size, rapid growth, excess adiposity, high food avidity (appetite), excess nutrient intake, aortic intima-medial thickening and low physical activity; and improves neurodevelopmental progress; 2) For the mother reduces post-partum weight retention and increases healthy nutritional and physical activity behaviours, and measures of mental health and quality of life.