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Background: Following COVID-19 and the lockdowns, maternity care and support for women after delivery have been temporary restructured. Studies show that COVID-19 adversely impacts pregnant and peripartum women in the general population, but experiences among women in the first year after delivery/in the wider postpartum period remain unexplored. Moreover, experiences among women with recent gestational diabetes mellitus (GDM) are lacking; though it is a group with a potential high need for support after delivery. The aim of our study was to investigate (i) how women with recent GDM experienced COVID-19 and the first lockdown in Denmark, and (ii) the women's risk perception and health literacy in terms of interaction with the healthcare system in relation to COVID-19.Methods: We performed a qualitative study among 11 women with recent GDM (infants aged 2-11 months old). Semi-structured interviews were conducted in April-May 2020 by telephone or Skype for Business, when Denmark was under lockdown. We analysed data using a thematic qualitative content analysis.Results: Three themes emerged: i) Everyday life and family well-being, ii) Worries about COVID-19 and iii) Health literacy: Health information and access to healthcare. The women were generally not worried about their own or their infant's risk of COVID-19. The lockdown had a negative impact on everyday life e.g. routines, loneliness, breastfeeding uncertainties and worries for the infant's social well-being; but better family dynamics were also described. It was challenging to maintain healthy behaviours and thus the women described worries for the risk of type 2 diabetes and GDM in subsequent pregnancies. The women missed peer support and face-to-face visits from health visitors and found it difficult to navigate the restructured care with online/telephone set-ups.Conclusions: COVID-19 and the lockdown affected everyday life among women with recent GDM both positively and negatively. Our findings suggest a need for care that are responsive to psychological and social aspects of health throughout the COVID-19 pandemic and support to limit worries about adaptation to motherhood and the infant's social well-being. Communication focusing on the importance and relevance of contacting healthcare providers should also be strengthened. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Gestational diabetes mellitus (GDM) is associated with an increased risk of future diabetes in both mother, father and offspring. More knowledge is needed about how to effectively reduce the risk of diabetes through sustained behavioural interventions in these families. The Face-it intervention is a complex health promotion intervention embedded in multi-level supportive environments. The aim of the intervention is to reduce type 2 diabetes risk and increase quality of life among families in the first year following a GDM-affected pregnancy by promoting physical activity, healthy dietary behaviours and breastfeeding through a focus on social support, motivation, self-efficacy, risk perception and health literacy.Methods: This national multicentre study is a two-arm randomised controlled trial including 460 women with GDM in a ratio of 2 (intervention):1 (usual care). The Face-it intervention consists of three main components: 1) additional visits from municipal health visitors, 2) digital health coaching tailored to family needs and 3) a structured cross-sectoral communication system in the health care system. The intervention runs from 3 to 12 months after delivery. The primary outcome is maternal body mass index at 12 months after delivery as a proxy for diabetes risk. The women will be examined at baseline and at follow-up, and this examination will include blood tests, oral glucose tolerance test (OGTT), anthropometrics, blood pressure, self-reported diet and physical activity, breastfeeding, quality of life, health literacy, physical and mental health status, risk perception and social support. Aside from those data collected for OGTT and breastfeeding and offspring parameters, the same data will be collected for partners. Data on offspring anthropometry will also be collected. Information on pregnancy- and birth-related outcomes will be derived from the medical records of the woman and child.Discussion: This randomised controlled trial seeks to demonstrate whether the Face-it intervention, addressing the individual, family and health care system levels, is superior to usual care in reducing diabetes risk for mothers and their families. Coupled with a process evaluation and an economic analysis, the study will provide evidence for policymakers and health services about health promotion among families affected by GDM and the potential for reducing risk of type 2 diabetes and associated conditions.Trial Registration: ClinicalTrials.gov NCT03997773. Registered June 25, 2019 - Retrospectively registered. [ABSTRACT FROM AUTHOR]