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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.

IntroductionGestational diabetes mellitus (GDM) is often associated with adverse pregnancy outcomes. However, the association of risk factors with GDM diagnosis, maternal and neonatal health outcomes is less established when compared with women without GDM. We aim to examine the diagnostic accuracy of the conventional and novel risk factors for a GDM diagnosis and their impact on maternal and neonatal health outcomes.Methods and analysisThis retrospective cohort and nested case–control study at six public health clinics is based on medical records and questionnaire survey of women between 2 and 12 months postpartum. The estimated required sample size is 876 complete records (292 cases, 584 control, at a ratio of 1:2). Oral glucose tolerance test results will be used to identify glucose dysregulation, and maternal and neonatal outcomes include maternal weight gain, pre-eclampsia, polyhydramnios, mode of delivery, preterm or postdate birth, complications in labour, birth weight, gestational age at birth, Apgar score, congenital anomaly, congenital hypothyroidism, neonatal death or stillbirth, hypoglycaemia and hyperbilirubinaemia. Psychosocial measures include the WHO Quality of Life: brief, mother–infant bonding (14-item Postpartum Bonding Questionnaire and 19-item Maternal Postnatal Attachment Scale), anxiety (7-item Generalised Anxiety Disorder), depression (9-item Patient Health Questionnaire) and stress (Perceived Stress Scale symptoms) questionnaires. The comparative incidences of maternal and neonatal health outcomes, the comparative prevalence of the psychosocial outcomes between women with GDM and without GDM, specificity, sensitivity, positive and negative predictive values of the risk factors, separately and combined, will be reported. All GDM risk factors and outcomes will be modelled using multivariable regression analysis and the receiver operating characteristics curve will be reported.Ethics and disseminationThis study was approved by the Malaysia Research and Ethics Committee, Ministry of Health Malaysia. Informed consent will be obtained from all participants. Findings will be submitted for publications in scientific journals.

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