A Digital Health Intervention to Enhance Self-care Capacities and Social Support for Women with Gestational Diabetes Mellitus in Northern Vietnam: A Mixed Method Feasibility Study (VALID-II)

Abstract Background: Gestational diabetes mellitus (GDM) is an increasingly prevalent health problem in low- and middle-income countries. In the majority of cases, the condition can be managed non-pharmacologically through changes in nutrition and exercise. As the global prevalence rises, it becomes imperative to explore self-care intervention for GDM as an alternative support beyond pharmacological treatments. This study assessed the feasibility of a co-createddigital self-care and social support intervention– the VALID II intervention. Methods: The intervention entailed several different components including educational materials (leaflets and videos) and digital supportive and educative elements via Zalo, private Facebook group, and Zoom meetings. Mixed methods were used to assess the feasibility of the VALID II intervention. We used an explanatory sequential design with a merging integration mixed method approach first collecting quantitative data, followed by the qualitative data and then co-analysing and comparing the data from various methods. Feasibility was assessed as a composite outcome through the following outcome measures: Recruitment rate, retention rate, and acceptability scores. Further, in-depth data on feasibility was collected through ethnographic interviews. The stop-go rules were pre-defined as 60% of recruitment rate and retention rate, and a median acceptability score of 3.0 or above. Results: A total of 202 women were diagnosed with GDM and invited to participate in the VALID II intervention group. All approached women gave informed consent to participate, achieving a 100% recruitment rate. A total of 154 women participated in the delivery and postpartum interviews, resulting in a retention rate of 76.2%. The medians of the acceptability score were 4.0. Both the recruitment, retention and acceptability rate satisfied the pre-registered stop-go rules. Furthermore, 21 women participated in the qualitative interviews, which revealed that despite challenges, the intervention was perceived as satisfactory and well-accepted. Conclusions: The VALID-II self-care and social support intervention targeted Vietnamese women with GDM was feasible, and has potential for a larger trial. Trial registration: NCT05744856. Trial status: Recruitment complete.