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

TY - JOUR

T1 - Process Evaluations of Interventions for the Prevention of Type 2 Diabetes in Women With Gestational Diabetes Mellitus

T2 - Systematic Review

AU - Sa'id, Iklil Iman Mohd

AU - Hotung, Natasha

AU - Benton, Madeleine

AU - Nadal, Iliatha Papachristou

AU - Baharom, Anisah

AU - Prina, Matthew

AU - Nisak Mohd Yusof, Barakatun

AU - Goldsmith, Kimberley

AU - Birts, Samantha

AU - Siew Mooi, Ching

AU - Forbes, Angus

AU - Ismail, Khalida

AU - Chew, Boon How

N1 - Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work is supported by MYPAIR Grant UK-Malaysia: Joint Partnership Call on Non-Communicable Diseases (Malaysia: JPT.S (BPKl) 2000/011/06/05 (27); UK: MR/T018240/1). Funding Information: We would like to thank the Ministry of Education Malaysia through the MyPAiR (Malaysia Partnership & Alliances in Research) program and the UK’s Medical Research Council that have jointly created the MyPAiR-Non-communicable Disease Year 2019 research grantfor providing the funding for this systemic review, a part of the Malaysian GestatiOnal Diabetes and prevention of DiabtES Study (MYGODDESS) ( https://bit.ly/3A8lJv6 ). We would like to thank our Knowledge User Advisory Panel members for providing guidance and feedback. Their contributions represent independent research part funded by the NIHR Biomedical Research Centre (South London and Maudsley NHS Foundation Trust and KCL) and the NIHR Applied Research Collaboration South London (King’s College Hospital NHS Foundation Trust). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. MYGODDESS Project team members and collaborators include Dr. Hanifatiyah Ali from the Department of Family Medicine Universiti Putra Malaysia who helped in the early protocol drafting by IIMS, Dr. Ziti Akthar Supian at Seri Kembangan Health Clinic, Dr. Haslinda Hassan at Puchong Health Clinic, Dr. Fuziah Paimin at Putrajaya Presint 9 Health Clinic, Dr. Nurain Mohd. Noor and Dr. Wan Ahmad Hazim Wan Ghazali from the Departments of Medicine and Obstetrics and Gynaecology in Hospital Putrajaya, respectively. Publisher Copyright: © The Author(s) 2021. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2025/2/6

Y1 - 2025/2/6

N2 - 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 mechanisms of 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 studies not 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.

AB - 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 mechanisms of 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 studies not 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.

KW - antenatal outcomes

KW - diabetes prevention

KW - gestational diabetes mellitus

KW - lifestyle intervention

KW - maternal outcomes

KW - process evaluations

KW - randomised controlled trial

UR - http://www.scopus.com/inward/record.url?scp=85113590898&partnerID=8YFLogxK

U2 - 10.2196/51718

DO - 10.2196/51718

M3 - Review article

C2 - 39913176

AN - SCOPUS:85113590898

SN - 1929-073X

VL - 14

SP - e51718

JO - Interactive Journal of Medical Research

JF - Interactive Journal of Medical Research

ER -