Digital therapeutics-based lifestyle intervention for gestational diabetes mellitus prevention of high-risk pregnant women: a study protocol for a non-randomised controlled trial.

ABSTRACT

INTRODUCTION: Digital therapeutics have been approved as a treatment aid for various medical conditions and are increasingly prevalent. Despite numerous studies on the potential of digital therapeutic interventions in preventing gestational diabetes mellitus (GDM), there is a critical need for more high-quality, large-scale studies to validate their effectiveness. This need arises from the inconsistencies in results and variations in the quality of previous research. METHODS AND ANALYSIS: We propose a non-randomised controlled trial involving 800 high-risk pregnant women in 6 maternity and child health hospitals in Fujian, China. This study aims to investigate the role and effectiveness of digital therapeutics-based lifestyle intervention in managing the health of pregnant women at high risk for GDM. The study will compare the differences in GDM prevalence, pregnancy weight management and other pregnancy-related health outcomes between pregnant women who received digital therapeutics-based lifestyle intervention and those in the control group. The intervention includes dietary guidance, a personalised physical activity programme and lifestyle improvement strategies delivered through a smartphone app. Primary outcomes include the incidence of GDM at 24-28 weeks gestation and gestational weight gain (GWG). Secondary outcomes comprise improvements in individual lifestyle and risk factors, nutritional issues, implementation outcomes and other pregnancy-related outcomes. ETHICS AND DISSEMINATION SECTION The trial was approved by the Ethics Committee of Fujian Maternity and Child Health Hospital (approval number 2023KY046), Jianyang Maternity and Child Health Hospital (approval number A202401), Fuqing Maternity and Child Health Hospital (approval number FY2024003), Changting Maternity and Child Health Hospital (approval number 202401), Datian Maternity and Child Health Hospital (approval number dtfy202401) and Quanzhou Maternity and Child Health Hospital (approval number 2024(50)). We will disseminate our findings by publishing articles in leading peer-reviewed journals. TRIAL REGISTRATION NUMBER ChiCTR2300071496.