HealthyMoms2.0- a digital platform to improve self-management of gestational diabetes mellitus and maternal and offspring health: a randomised controlled trial

Gestational diabetes mellitus (GDM) is an increasing public health challenge.

Innovative, effective and scalable lifestyle interventions to support women with GDM to manage their disease and to prevent adverse obstetric and neonatal outcomes as well as later morbidity are requested.The aim of this project is to evaluate whether a novel, mobile health (mHealth) platform (HealthyMoms2.0) can improve self-management of GDM and prevent adverse maternal and offspring outcomes.HealthyMoms2.0 is a multi-centre randomised controlled trial recruiting women diagnosed with GDM in gestational week 24-28 in South Eastern Sweden. 420 women will be randomised to the control or intervention group (1:1).

All women will receive standard care.

The intervention group will also receive support through the HealthyMoms2.0 platform for healthy eating, physical activity and glycaemic control.

Pregnancy outcomes are glycaemic control i.e., time in target range (primary), diet, physical activity (ActiGraph), metabolic and inflammatory biomarkers in week 36-37 as well as adverse obstetric and neonatal outcomes (registers).

Secondary outcomes are cardiometabolic risk, physical activity and healthy eating behaviours one-year postpartum.If successful, the HealthyMoms2.0 platform has the potential to be implemented nationally as an evidence-based, scalable tool to prevent adverse obstetric and neonatal outcomes in pregnant women with GDM as well as to improve long-term health in mothers and their offspring.