No abstract

Background Process evaluations of randomised controlled trials (RCTs) can provide insight and inform us on the intervention implementation, the causal mechanisms and the contextual factors. This will inform about interventions’ success or failure due to their implementation or the interventions themselves. We aim to consolidate the methodology from previous process evaluations of complex interventions upon their findings on facilitators and barriers to address the prevention of type 2 diabetes mellitus among women with gestational diabetes mellitus (GDM). Methods Comprehensive search will be conducted on electronic databases and reference lists of recent reviews for RCTs of complex interventions which address process evaluations of diabetes prevention intervention (DPI) for women with GDM in healthcare settings. There is no restriction on the language of the papers and year of publication until December 2020. Data from each study will be extracted by two reviewers independently using standardised forms. Data extracted include descriptive items on the study design and the outcomes of process evaluations from the three dimensions: (1) implementation; (2) mechanism of impact and (3) context. The quality of the studies will be assessed using mixed methods appraisal tool which is designed for the appraisal of mixed studies in systematic reviews. A narrative and framework analysis of the findings will be presented to inform the contents of a new DPI for women with GDM. Discussion The findings from this process evaluation findings are valuable in determining whether a complex intervention should be scaled up or modified for other contexts in future plan. It will give deeper understanding of potential challenges and solutions to aid in the implementation of effective DPIs for GDM in Malaysia.

Background: Process evaluations of randomized controlled trials (RCTs) can provide insight and inform us on the intervention implementation, causal mechanisms and the contextual factors; whether an intervention is effective or ineffective due to implementation failure or failure of the intervention itself. Hence, we aim to consolidate the methodology from previous process evaluations of complex interventions in healthcare services upon their findings on facilitators and barriers to address the prevention of type 2 diabetes among women with gestational diabetes mellitus (GDM). Methods: Comprehensive search will be conducted on electronic databases, trial registers, and reference lists of recent reviews for RCTs of complex interventions which address process evaluations of diabetes prevention intervention (DPI) for women with GDM in healthcare settings. There are no restriction on the year of publication and language of the papers. Data from each study will be extracted by two reviewers independently using standardized forms. Data extracted include descriptive items on the study design and the outcomes of process evaluations from the three dimensions: (1) implementation (theoretical framework, reach, dose delivered, dose received, fidelity, behaviour change techniques and competency in delivering them); (2) mechanistic (format of delivery either digital, non-digital or hybrid, participant and healthcare provider experience and feedback; (3) contextual (socio-cultural context, the organisational factors, local and national policy factors as barriers, facilitators, contamination and adoption for the DPI and the control as well as the conflict of interest). The quality of the studies will be assessed using mixed methods appraisal tool (MMAT) which designed for the appraisal stage of systematic mixed studies reviews. A narrative and thematic synthesis of the findings will be presented to inform the contents of a new DPI for women with GDM. Discussion: The findings from this process evaluation findings are valuable in determining whether a complex intervention should be scaled up or modified for other contexts in future plan. Publishing this protocol could benefit our understanding on how the process evaluation have been conducted thus far and give deeper input in understanding potential challenges and solutions to aid in the implementation of effective DPIs for GDM in Malaysia. Systematic Review Registration: CRD42020208212

IntroductionWomen who develop gestational diabetes mellitus (GDM) have an increased risk of developing type 2 diabetes, and to reduce this risk the women have to adopt healthy behaviour changes. Although previous studies have explored the challenges and facilitators to initiate behaviour change among women with GDM, there is limited data from Malaysian women. Thus, this study will explore the factors affecting the uptake of healthy behaviour changes and the use of digital technology among women and their healthcare providers (HCPs) to support healthy behaviour changes in women with GDM.Methods and analysisThe study will be modelled according to the Capability, Opportunity, Motivation and Behaviour and Behaviour Change Wheel techniques, and use the DoTTI framework to identify needs, solutions and testing of a preliminary mobile app, respectively. In phase 1 (design and development), a focus group discussion (FGDs) of 5–8 individuals will be conducted with an estimated 60 women with GDM and 40 HCPs (doctors, dietitians and nurses). Synthesised data from the FGDs will then be combined with content from an expert committee to inform the development of the mobile app. In phase 2 (testing of early iterations), a preview of the mobile app will undergo alpha testing among the team members and the app developers, and beta testing among 30 women with GDM or with a history of GDM, and 15 HCPs using semi-structured interviews. The outcome will enable us to optimise an intervention using the mobile app as a diabetes prevention intervention which will then be evaluated in a randomised controlled trial.Ethics and disseminationThe project has been approved by the Malaysia Research Ethics Committee. Informed consent will be obtained from all participants. Outcomes will be presented at both local and international conferences and submitted for publications in peer-reviewed journals.