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

Sa'id IIM, Hotung N, Benton M, Nadal IP, Baharom A, Prina M, et al.

Interact J Med Res, 2025 Feb 06;14:e51718.
PMID: 39913176 DOI: 10.2196/51718

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.
Fulltext Protocol for a qualitative study exploring the perception of need, importance and acceptability of a digital diabetes prevention intervention for women with gestational diabetes mellitus during and after pregnancy in Malaysia (Explore-MYGODDESS)

Sobri NHM, Ismail IZ, Hassan F, Papachristou Nadal I, Forbes A, Ching SM, et al.

BMJ Open, 2021 08 26;11(8):e044878.
PMID: 34446477 DOI: 10.1136/bmjopen-2020-044878

INTRODUCTION: Women 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 ANALYSIS: The 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 DISSEMINATION: The 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.
Fulltext A Mobile Phone App for the Prevention of Type 2 Diabetes in Malaysian Women With Gestational Diabetes Mellitus: Protocol for a Feasibility Randomized Controlled Trial

Benton M, Iman I, Goldsmith K, Forbes A, Ching SM, Papachristou Nadal I, et al.

JMIR Res Protoc, 2022 Sep 08;11(9):e37288.
PMID: 36074545 DOI: 10.2196/37288

BACKGROUND: Over 50% of women with a history of gestational diabetes mellitus (GDM) will develop type 2 diabetes (T2D) in later life. Asian women experience a disproportionate risk of both GDM and T2D compared to women from other ethnic backgrounds. Lifestyle interventions and behavior change can delay or even prevent the onset of T2D. We have developed a digitalized diabetes prevention intervention for the prevention of T2D in Malaysian women with GDM.
OBJECTIVE: The protocol describes a randomized controlled trial (RCT) to test the feasibility of undertaking a definitive trial of a diabetes prevention intervention, including a smartphone app and group support. Secondary aims are to summarize anthropometric, biomedical, psychological, and lifestyle outcomes overall and by allocation group, and to undertake a process evaluation.
METHODS: This is a two-arm parallel feasibility RCT. A total of 60 Malaysian women with GDM will be randomized in the antenatal period to receive the intervention or standard care until 12 months post partum. The intervention is a diabetes prevention intervention delivered via a smartphone app developed based on the Information-Motivation-Behavioral Skills model of behavior change and group support using motivational interviewing. The intervention provides women with tailored information and support to encourage weight loss through adapted dietary intake and physical activity. Women in the control arm will receive standard care. The Malaysian Ministry of Health's Medical Research and Ethics Committee has approved the trial (NMRR-21-1667-60212).
RESULTS: Recruitment and enrollment began in February 2022. Future outcomes will be published in peer-reviewed health-related research journals and presented at national, regional, or state professional meetings and conferences. This publication is based on protocol version 2, January 19, 2022.
CONCLUSIONS: To our knowledge, this will be the first study in Malaysia that aims to determine the feasibility of a digital intervention in T2D prevention among women with GDM. Findings from this feasibility study will inform the design of a full-scale RCT in the future.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05204706; https://clinicaltrials.gov/ct2/show/NCT05204706.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37288.
Knowledge as a Predictor for Preparedness in Managing COVID-19 Among General Practitioners in Malaysia

Abd Malek K, Ariffin F, Taher SW, Abd Aziz NA, Chew BH, Wong PF, et al.

Cureus, 2024 Jun;16(6):e63147.
PMID: 39055414 DOI: 10.7759/cureus.63147

Introduction The COVID-19 pandemic has changed the working environment for general practitioners (GPs). GPs had to adapt quickly when care mitigation for mild COVID-19 in the community began. We assessed Malaysian GPs' knowledge and preparedness to manage COVID-19. Method A cross-sectional online survey was conducted between May and October 2022 among the GPs. Emails were sent to GPs affiliated with the main GP organizations in Malaysia, such as the Academy of Family Physicians of Malaysia (AFPM). Additionally, participation was sought through social media groups, including the Association of Malaysian Islamic Doctors, the Federation of Private Medical Practitioners' Associations Malaysia, and the Primary Care Network. Data was collected using a self-administered questionnaire on items related to knowledge and preparedness to manage COVID-19. The content was validated by six experts. Multiple logistic regression was used to determine the predictors for preparedness. Results A total of 178 GPs participated in this study. The mean age of the GPs was 41.8 (SD 12.37) years, 54.5% were males, 47.8% had a postgraduate qualification, and 68% had up to 10 years of general practice experience. Their practices are commonly solo (55.1%), located within an urban area (56.2%) and 47.2% operate 7 days a week. A majority of GPs (n = 124, 69.7%) had a good level of knowledge of COVID-19. In contrast, about a third (n = 60, 33.7%) had a good level of preparedness to manage COVID-19. GPs with a good level of knowledge of COVID-19 had 1.96 times the odds of having a good level of preparedness as compared to GPs with lower knowledge (OR = 2.11 (95% CI: 1.06, 4.18, p = 0.03)). Conclusion A good level of knowledge is a predictor for preparedness to manage COVID-19. Relevant and targeted measures to enhance knowledge for better preparedness among the GPs to respond to future pandemics are needed.
Fulltext Effectiveness of the EMPOWER-PAR Intervention in Improving Clinical Outcomes of Type 2 Diabetes Mellitus in Primary Care: A Pragmatic Cluster Randomised Controlled Trial

Ramli AS, Selvarajah S, Daud MH, Haniff J, Abdul-Razak S, Tg-Abu-Bakar-Sidik TM, et al.

BMC Fam Pract, 2016 11 14;17(1):157.
PMID: 27842495

BACKGROUND: The chronic care model was proven effective in improving clinical outcomes of diabetes in developed countries. However, evidence in developing countries is scarce. The objective of this study was to evaluate the effectiveness of EMPOWER-PAR intervention (based on the chronic care model) in improving clinical outcomes for type 2 diabetes mellitus using readily available resources in the Malaysian public primary care setting.

METHODS: This was a pragmatic, cluster-randomised, parallel, matched pair, controlled trial using participatory action research approach, conducted in 10 public primary care clinics in Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Patients who fulfilled the criteria were recruited over a 2-week period by each clinic. The obligatory intervention components were designed based on four elements of the chronic care model i.e. healthcare organisation, delivery system design, self-management support and decision support. The primary outcome was the change in the proportion of patients achieving HbA1c
Fulltext Study protocol of EMPOWER participatory action research (EMPOWER-PAR): a pragmatic cluster randomised controlled trial of multifaceted chronic disease management strategies to improve diabetes and hypertension outcomes in primary care

Ramli AS, Lakshmanan S, Haniff J, Selvarajah S, Tong SF, Bujang MA, et al.

BMC Fam Pract, 2014;15:151.
PMID: 25218689 DOI: 10.1186/1471-2296-15-151

Chronic disease management presents enormous challenges to the primary care workforce because of the rising epidemic of cardiovascular risk factors. The chronic care model was proven effective in improving chronic disease outcomes in developed countries, but there is little evidence of its effectiveness in developing countries. The aim of this study was to evaluate the effectiveness of the EMPOWER-PAR intervention (multifaceted chronic disease management strategies based on the chronic care model) in improving outcomes for type 2 diabetes mellitus and hypertension using readily available resources in the Malaysian public primary care setting. This paper presents the study protocol.