Date

2020-09-03

Protocol

Protocol changed

Item Changed

Primary outcome(s) - Time of assessment(s)

Previous Version

1.Proportion of women with a change of glycaemic category, at or prior to final visit: • Normal glucose tolerance to impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) or T2DM • IFG or IGT to T2DM [At baseline and at the final visit. (The median follow up period of the study is 24 months and minimum follow up is 12 months.The end of study visit would be different for each participant depending on when they are randomized) ]

Next Version

From March 25, 2020, due to lockdown measures relating to the Covid-19 emergency, the following changes to participant follow-up have been instituted: 1. All follow-up visits with study participants will be conducted remotely via telephone. This will exclude the ability to collect any data relating to anthropometric measurements, OGTT, HbA1c and vitals (BP and heart rate). 2. All participants who have completed at least 12 months follow-up (and, if randomised to the intervention, have completed all aspects of the intervention) will have an EOS visit scheduled as their next visit. 3. Once lockdown conditions have been lifted, all participants will be scheduled for a visit to, at a minimum, undergo testing for HbA1c and undergo an OGTT. If conditions allow, in-clinic visits will be arranged for anthropometric measures and vitals (BP and heart rate).