Digital Therapeutics-Based Lifestyle Intervention for Gestational Diabetes Mellitus Prevention of High-Risk Pregnant Women: a Study Protocol for a Non-Randomised Controlled Trial

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.