Process Evaluations of Interventions for the Prevention of Type 2 Diabetes in Women With Gestational Diabetes Mellitus: Systematic Review

Background: Gestational diabetes mellitus (GDM) is characterized by hyperglycemia in pregnancy and typically resolves after birth. Women with GDM have an increased risk of developing type 2 diabetes mellitus (T2DM) later in life compared to those with normoglycemic pregnancy. While diabetes prevention interventions (DPIs) have been developed to delay or prevent the onset of T2DM, few studies have provided process evaluation (PE) data to assess the mechanismsof impact, quality of implementation, or contextual factors that may influence the effectiveness of the intervention. Objective: This study aims to identify and evaluate PE data and how these link to outcomes of randomized controlled trials (RCTs) of T2DM prevention interventions for women with GDM. Methods: A systematic review was conducted to identify studies published from 2005 to 2020 aiming to capture the most recent DPIs. Five electronic bibliographic databases(Cochrane Library, Cochrane Collaboration Registry of Controlled Trials, Embase, PubMed, and MEDLINE) were searched to identify relevant studies. Inclusion criteria were published (peer-reviewed) RCTs of DPIs in women with a current diagnosis or history of GDM. Exclusion criteria were studiesnot published in English; studies where the target population was women who had a family history of T2D or women who were menopausal or postmenopausal; and gray literature, including abstracts in conference proceedings. The Medical Research Council's PE framework of complex interventions was used to identify key PE components. The Mixed Method Appraisal Tool was used to assess the quality of included studies. Results: A total of 24 studies were included; however, only 5 studies explicitly reported a PE theoretical framework. The studies involved 3 methods of intervention delivery, including in person (n=7), digital (n=7), and hybrid (n=9). Two of the studies conducted pilot RCTs assessing the feasibility and acceptability of their interventions, including recruitment, participation, retention, program implementation, adherence, and satisfaction, and 1 study assessed the efficacy of a questionnaire to promote food and vegetable intake. While 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:While the Medical Research Council's framework is a valuable source for conducting systematic reviews on PEs, it has been criticized for lacking practical advice on how to conduct them. The lack of information on PE frameworks in our review also made it difficult to categorize individual PE components against the framework. We need clearer guidance and robust frameworks for conducting PEs for the development and reporting of DPIs for women with GDM. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42020208212; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=208212 International Registered Report Identifier (IRRID): RR2-https://doi.org/10.1177/16094069211034010