BACKGROUND
Women with gestational diabetes mellitus (GDM) have an increased risk of developing type 2 diabetes mellitus (T2DM) later in life. Whilst diabetes prevention interventions (DPI) have been developed to delay or prevent the onset of T2DM, few studies have provided process evaluation (PE) data to assess the mechanisms of impact, quality of implementation or contextual factors that may influence the effectiveness of the intervention in practice. The aim of this review was to identify and evaluate PE data and how these link to outcomes of randomised control trials of T2DM prevention interventions for women with GDM.
OBJECTIVE
Specific objectives were to identify the extent to which PE components were reported and described in RCTs of DPIs for women with previous or current GDM and to assess whether these components could contribute to explaining the intervention outcomes of the DPIs.
METHODS
A systematic review was conducted to identify studies published from 2005–2020. Five electronic bibliographic databases (Cochrane Library, Cochrane Collaboration Registry of Controlled Trials, EMBASE, PubMed, and MEDLINE) were searched using the Medical Research Council’s PE framework of complex interventions to identify key PE components.
RESULTS
Twenty-four studies were included. Only five explicitly reported a PE theoretical framework. Whilst most studies linked PE data with study outcomes, it was unclear which of the reported PE components were specifically linked to the positive outcomes.
CONCLUSIONS
We need clearer guidance and robust frameworks for conducting PEs for the development and reporting of DPIs for women with GDM.
INTERNATIONAL REGISTERED REPORT
RR2-https://doi.org/10.1177/16094069211034010