Researchers at University College Dublin (UCD) published the full study protocol for Bump2Baby & Me+ (B2B&Me+) today. This is a study testing how a digital health coaching programme for pregnant women at risk of gestational diabetes performs when it moves out of a clinical trial and into routine hospital care. Publication coincides with the close of the study's recruitment phase, which began in December 2025 across hospitals in Ireland, Spain, Poland and Norway.
Gestational diabetes affects roughly one in seven pregnancies worldwide. It raises the risks for both the woman and her baby - women who develop gestational diabetes have a tenfold increased risk of developing type 2 diabetes compared with the general pregnant population. Globally rates are rising – earlier this month the UK announced their rates of gestational diabetes had surged up by 60% and now match Ireland's. This change in rates is driven in part by more women getting pregnant when they are older and living with obesity or overweight.
B2B&Me+ is designed to answer whether the positive health outcomes achieved during the original Bump2Baby and Me trial will hold up once the health coaching is offered to all women at higher risk in busy maternity services. The study will run in four different maternity hospitals across Europe: the National Maternity Hospital, Dublin; University Hospital San Cecilio, Granada; Sørlandet Hospital Trust, Kristiansand; and Pomeranian Medical University Hospital, Szczecin. The study will compare a block of health coaching delivery against periods of usual care at each site. Women who join the programme are matched with a health coach through a smartphone app, receive a Bluetooth-enabled weighing scale for self-monitoring, and are supported from early pregnancy through to nine months after birth.
The study will also compare different ways of inviting at-risk women onto the programme as a way of checking which way would be more successful in enrolling and reaching women in practice. The project findings will feed into a European implementation toolkit, intended to give other health services practical, costed guidance on introducing the programme.
"We already know this kind of coaching can improve women's health when it's delivered under trial conditions. The harder question - and the one health services actually need answered - is whether it still works once it's part of how a busy maternity unit runs. That's what this study is trying to find out."
— Professor Sharleen O'Reilly, School of Agriculture and Food Science, UCD, and Principal Investigator, Bump2Baby & Me+
The study finishes recruitment closes at the end of August but the health coaching continues until mid-2027, with results expected in 2028. The study is funded through the EU Horizon Europe Transforming Health and Care Systems partnership, alongside national funding bodies in Ireland, Denmark, Norway, Poland and Spain, and is registered with ClinicalTrials.gov (NCT07189221).
