Background Women with prior gestational diabetes mellitus (GDM) are at high risk of developing type 2 diabetes; however, this risk can be reduced by engaging in positive health behaviours e.g. healthy diet and regular physical activity. As such behaviours are difficult to obtain and maintain there is a need to develop sustainable behavioural interventions following GDM. We aimed to report the process of systematically developing a health promotion intervention to increase quality of life and reduce diabetes risk among women with prior GDM and their families. We distil general lessons about developing complex interventions through co-production and discuss our extensions to intervention development frameworks. Methods The development process draws on the Medical Research Council UK Development of complex interventions in primary care framework and an adaptation of a three-stage framework proposed by Hawkins et al. From May 2017 to May 2019, we iteratively developed the Face-it intervention in four stages: 1) Evidence review, qualitative research and stakeholder consultations; 2) Co-production of the intervention content; 3) Prototyping, feasibility- and pilot-testing and 4) Core outcome development. In all stages, we involved stakeholders from three study sites. Results During stage 1, we identified the target areas for health promotion in families where the mother had prior GDM, including applying a broad understanding of health and a multilevel and multi-determinant approach. We pinpointed municipal health visitors as deliverers and the potential of using digital technology. In stage 2, we tested intervention content and delivery methods. A health pedagogic dialogue tool and a digital health app were co-adapted as the main intervention components. In stage 3, the intervention content and delivery were further adapted in the local context of the three study sites. Suggestions for intervention manuals were refined to optimise flexibility, delivery, sequencing of activities and from this, specific training manuals were developed. Finally, at stage 4, all stakeholders were involved in developing realistic and relevant evaluation outcomes. Conclusions This comprehensive description of the development of the Face-it intervention provides an example of how to co-produce and prototype a complex intervention balancing evidence and local conditions. The thorough, four-stage development is expected to create ownership and feasibility among intervention participants, deliverers and local stakeholders. Trial registration ClinicalTrials.gov NCT03997773, registered retrospectively on 25 June 2019.
In many countries, immigrant women constitute a substantial proportion of women giving birth. With gestational diabetes being one of the most common complications in pregnancy, understanding gestational diabetes in the context of international migration becomes increasingly relevant. Here, we examine the current evidence related to international migration and gestational diabetes, including short and long-term adverse outcomes and the experiences of immigrant women with gestational diabetes care and long-term follow-up. Existing evidence focuses on immigrants in high-income countries and has mainly examined differences in risk of developing gestational diabetes or on the experiences of immigrant women diagnosed with gestational diabetes. Studies suggest that the risk of gestational diabetes may be influenced by migration and that immigrant women likely experience particular barriers to care and follow-up. Current research on perinatal outcomes is inconclusive and studies on long-term outcomes are practically absent. Future research should include data on country of origin and examine the role of pre- and post-migration factors in developing gestational diabetes and its associated short- and long-term outcomes. Understanding these factors will provide useful insights into improving the health and healthcare needs of migrating populations and enable inclusion of culturally appropriate healthcare practices, thereby improving the health of our current and future generations
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