Systematically developing a family-based health promotion intervention for women with prior gestational diabetes based on evidence, theory and co-production: the Face-it study
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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.
|BMC Public Health
|Udgivet - 2021
The Face-it study is funded by an unrestricted grant from the Novo Nordisk Foundation NNF17OC0027826. The funders have no role in the study design, data collection, analysis or the publishing of the results.
The authors wish to thank the following institutions for their support: Steno Diabetes Center Aarhus, Steno Diabetes Center Odense, Steno Diabetes Center Copenhagen, Aarhus University, Rigshospitalet, Odense University Hospital, Aarhus University Hospital, Aarhus Municipality, Copenhagen Municipality, Odense Municipality, and LIVA healthcare. The authors would like to thank the international advisory board (David McIntyre, Kaberi Dasgupta and Sharleen O?Reilly), the Face-it Steering Committee and Rebecca Simmons for critical input to manuscript and language editing. Finally, we would like to thank the families and healthcare providers who contributed to the development of the Face-it intervention.
© 2021, The Author(s).
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