Multicenter trial validates continuous pregnancy-to-postpartum mobile health coaching program

A continuous, personalized mobile health (mHealth) coaching program can significantly reduce gestational diabetes incidence among high-risk pregnant women, independent of changes to maternal weight – according to an international study published today in the Lancet Digital Health.

Led by Prof Sharleen O'Reilly from University College Dublin, School of Agriculture and Food Science, the 'Bump2Baby and Me' (B2B&Me) study evaluated the efficacy of a smartphone-delivered intervention from early pregnancy through 12 months postpartum. The multicenter randomized controlled trial (RCT), spanning Ireland, the UK, Spain, and Australia, is the first of its scale to provide a digital health intervention continuously through both pregnancy and an extended postpartum period.

The risk for developing gestational diabetes is strongly linked to obesity or overweight. 'Lifestyle' interventions typically focus on improving diet, physical activity and weight management. The B2B&Me study followed two groups who received routine care only or routine care plus personalized mHealth coaching through the B2B&Me app. The study found no difference in average maternal body mass index (BMI) at 12 months postpartum between the two groups but they did find a clinically important reduction in the number of women who developed gestational diabetes for the B2B&Me app group.

These findings have potential clinical implications – showing that gestational diabetes prevention and improvements in metabolic health can be achieved without corresponding weight change. Additionally, the study noted that regular self-weighing using simple, Bluetooth-enabled digital scales was independently associated with a significant reduction in body mass index (BMI)*.

Project Lead and Principal Investigator at UCD School of Agriculture and Food Science, Prof Sharleen O'Reilly said: "The Bump2Baby and Me trial showed that continuous, high-quality engagement with mHealth coaching can improve metabolic outcomes and reduce gestational diabetes incidence, independently of weight change.

By utilizing mHealth technology, we can deliver support in real-time directly to women when and where they need it most. Our research provides a robust, scalable framework to alleviate pressure on routine maternity services while extending preventive care beyond the hospital walls into the vital first year postpartum."

Sharleen O'Reilly, Professor, Project Lead and Principal Investigator, School of Agriculture and Food Science, University College Dublin

The trial enrolled 865 pregnant women between 12 and 24 weeks' gestation who were identified as being at increased gestational diabetes risk. Participants all received a Bluetooth-enabled scales and were randomized to either receive usual care or join the mHealth coaching program, which used a smartphone application to provide tailored health coach support for nutrition, physical activity, and well-being. The coaches, who were trained healthcare professionals, provided live and text or video support sessions to women.

Importantly, the intervention was found to be safe, with no adverse events related to the mHealth coaching program, while the diversity across four different healthcare systems enhances the findings generalizability to different populations.

Bridging the gap between clinical trial success and healthcare implementation remains important. To achieve this, the team has already launched a successor initiative, Bump2Baby&Me+. Supported by €2 million in partnership funding under Horizon Europe, this initiative will focus heavily on implementation science, determining how to embed this evidence-based mHealth coaching program into routine maternity services in diverse healthcare settings.