A Co-created Self-care and Informal Support Intervention Targeting Women with Gestational Diabetes Mellitus in Northern Vietnam (VALID-II): A Protocol for a Two-arm Non-randomised Pilot Trial

Abstract

Abstract Background Gestational diabetes mellitus (GDM) is a transitory form of diabetes that presents during pregnancy with frequent adverse maternal and neonatal health consequences if left untreated. GDM is rapidly increasing in low- and middle-income countries such as Vietnam, and early sustainable interventions are important. The overall aim of this study – henceforth referred to as VALID-II – is to assess the feasibility of a co-created self-care and informal support intervention targeted pregnant women with GDM and the degree to which it can reduce maternal and neonatal health complications compared to standard care. Methods VALID-II is a two-site, two-arm, non-randomised pilot trial in Thai Binh Province in Northern Vietnam with a delayed start for the intervention group. In total, 2000 pregnant women will be screened for GDM with estimated 400 women screening positive according to World Health Organization - International Association of Diabetes and Pregnancy Study Groups diagnostic criteria. Firstly, 200 women, who screen positive for GDM, will be assigned to a control group that will receive standard care. Of the 200 women, 20 will take part in an in-depth ethnographic study along with their family members, and the intervention will be co-created with them. Secondly, once the intervention has been created, 200 women will be assigned to the intervention group that will receive the intervention plus standard care. Twenty women and their families from the intervention group will also take part in an ethnographic study. The primary outcomes are to evaluate how feasible the self-care intervention is (recruitment, retention, and acceptability) and the number of new-borns born large for gestational age. Secondary outcomes include other maternal and neonatal health outcomes, prevalence, and risk factors for GDM, self-care agency, self-care, and breast-feeding practices. Discussion This study will provide knowledge of the extent to which an informal/self-care and social support intervention can enhance maternal and child health outcomes among women with GDM in Northern Vietnam and the feasibility for a full-scale randomised trial. This may guide decision makers on how to optimise management of GDM in a low- and middle-income context. Trial registration: NCT05744856. Trial status: Recruiting.