Development of a tool to estimate sugar and caloric contents in alcoholic beverages for a diabetes self-management program in Thailand.

Diabetes self-management education and support (DSMES) is recommended as a standard of care for patients with diabetes worldwide. Alcohol consumption is one aspect mentioned within the DSMES program in Thailand where alcohol consumption is the highest among Southeast Asian countries. Many diabetes guidelines suggest limiting alcohol intake to not more than one standard drink per day for adult women and two for adult men if they cannot abstain from drinking. In practice, however, the conversion of alcohol consumption into standard drinks, and nutritional information about the calorie and sugar contents of alcoholic beverages, especially domestically produced spirits, are not commonly available in Thailand. By reviewing the diabetes guidelines internationally and the Thailand alcoholic beverage industry, a visual health education tool to help convert different alcoholic beverages into standard drinks and to provide the calorie and sugar content of alcoholic beverages was developed as a part of the DSMES program. It was finalized following pilot testing and focus group discussions with policymakers, healthcare providers, and type 2 diabetes patients. The personalized counseling tool, integrated with guidelines and culturally tailored to the Thai setting is distributed to counselors/educators. It is a potentially useful tool for patients to make informed choices for their self-management of diabetes.

A mixed-methods study on the implementation of a mobile health application (mHealth app) for stroke caregivers in Malaysia: healthcare providers' perspective.

Introduction: Recognizing the burden experienced by caregivers of stroke survivors, an intervention using mobile health applications (mHealth apps) has been proposed to support and empower stroke caregivers. This study aimed to assess the acceptability and expectations of healthcare providers, who play a vital role as gatekeepers in the healthcare system, to ensure the effectiveness and sustainability of the intervention. Methods: This was a concurrent mixed-method study design, with healthcare providers involved in stroke care management in the northeast regions of Malaysia as study participants. The qualitative component of the study was conducted using a phenomenological approach that involved in-depth interviews to explore the acceptability and expectations of healthcare providers regarding the adoption of mHealth apps in the context of stroke caregiving. The study was complemented by quantitative data collected through an online survey using an adjusted version of the technology acceptance model tool. Results: In total, 239 participants from diverse backgrounds and professions were enrolled in the study, with 12 in the qualitative component and 227 in the quantitative component. The findings from the quantitative survey showed that over 80% of the participants expressed their intention to use mHealth apps. The qualitative component generated two themes related to the acceptability and expectations of mHealth apps, which were integrated with the quantitative findings. Additionally, in-depth interviews revealed a new theme, namely the key features of mHealth, with three sub-themes: availability of services for caregivers, provision of knowledge skills, and supporting caregivers in managing stroke patients. Conclusion: Healthcare providers demonstrated excellent acceptability of this mHealth intervention as part of caregiving assistance, particularly with the inclusion of essential key features. However, future investigations are necessary to establish the feasibility of integrating the mHealth app into the healthcare system and to ensure its long-term sustainability.

Experiences and needs of the caregivers of stroke survivors in Malaysia-A phenomenological exploration.

Introduction: Informal caregivers play a crucial role in supporting the activities of daily living, rehabilitation, and the road to recovery for stroke survivors. However, these informal caregivers are often reported as experiencing neglect and lack of recognition despite their primary contribution to stroke recovery. This study investigated the experiences of the caregivers of stroke survivors and access to stroke care in Malaysia. Method: This qualitative study with a phenomenological approach utilized in-depth interviews, including ten primary caregivers, one formal caregiver, and stroke healthcare providers as the participants. The interviews were done until the data saturation was achieved, and the data was analyzed using thematic analysis. Result: Three primary themes and 14 subthemes were identified from the interviews. The role of primary caregivers of stroke survivors had tremendous physical, mental and social impact on the caregivers. Caregivers had two primary needs. The need for information about comprehensive stroke care at home and the need for psychological support to themselves. The key internal driver for providing care was identified to be the motivation level of the stroke survivor and the external driver was identified to be the societal support with access to comprehensive stroke care. Conclusion: The role of informal caregivers becomes critical for continuum of stroke care. As caregivers take up the roles and responsibilities of those who contribute to stroke rehabilitation single-handedly soon after hospital discharge. Results of this study highlights the needs for providing systematic support to caregivers for engaging them in effective stroke care, particularly in the community. Stroke service providers, policy makers and program planners must be sensitized to empower caregivers of stroke survivors in effectively supporting stroke survivor in their family on the road of recovery.

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.

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.

Study protocol on risk factors for the diagnosis of gestational diabetes mellitus in different trimesters and their relation to maternal and neonatal outcomes (GDM-RIDMAN).

INTRODUCTION: Gestational 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 ANALYSIS: This 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 DISSEMINATION: This 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.

Process evaluation protocol of a cluster randomised trial for a scalable solution for delivery of Diabetes Self-Management Education in Thailand (DSME-T).

INTRODUCTION: Type 2 diabetes mellitus is a major global challenge, including for Thai policy-makers, as an estimated 4 million people in Thailand (population 68 million) have this condition. Premature death and disability due to diabetes are primarily due to complications which can be prevented by good risk factor control. Diabetes Self-Management Education (DSME) programmes provide patients with diabetes with the necessary knowledge and skills to effectively manage their disease. Currently, a trial is being conducted in Thailand to evaluate the effectiveness, defined as HbA1c<7 at 12 months after enrolment, of a culturally tailored DSME in Thailand. A process evaluation can provide further interpretation of the results from complex interventions as well as insight into the success of applying the programme into a broader context. METHODS AND ANALYSIS: The aim of the process evaluation is to understand how and why the intervention was effective or ineffective and to identify contextually relevant strategies for future successful implementation. For the process evaluation, the design will be a mixed-method study collecting data from nurse providers, and village health volunteers (community health workers) as well as patients. This will be conducted using observations, interviews and focus groups from the three purposively selected groups at the beginning and end of trial. Quantitative data will be collected through surveys conducted at the beginning, during 6-month follow-up, and at the end of trial. The mixed-methods analysis will be triangulated to assess differences and similarities across the various data sources. The overall effectiveness of the intervention will be examined using multilevel analysis of repeated measures. ETHICS AND DISSEMINATION: Study approved by the Chiang Mai University Research Ethics Committee (326/2018) and the London School of Hygiene & Tropical Medicine (16113/RR/12850). Results will be published in open access, peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT03938233.

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).

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.

Scalable solution for delivery of diabetes self-management education in Thailand (DSME-T): a cluster randomised trial study protocol.

INTRODUCTION: Type 2 diabetes mellitus is among the foremost health challenges facing policy makers in Thailand as its prevalence has more than tripled over the last two decades, accounting for considerable death, disability and healthcare expenditure. Diabetes self-management education (DSME) programmes show promise in improving diabetes outcomes, but this is not routinely used in Thailand. This study aims to test a culturally tailored DSME model in Thailand, using a three-arm cluster randomised controlled trial comparing a nurse-led model, a peer-assisted model and standard care. We will test which model is effective and cost effective to improve cardiovascular risk and control of blood glucose among people with diabetes. METHODS AND ANALYSIS: 21 primary care units in northern Thailand will be randomised to one of three interventions, enrolling a total of 693 patients. The primary care units will be randomised (1:1:1) to participate in a culturally-tailored DSME intervention for 12 months. The three-arm trial design will compare effectiveness of nurse-led, peer-assisted (Thai village health volunteers) and standard care. The primary trial outcomes are changes in haemoglobin A1c and cardiovascular risk score. A process evaluation and cost effectiveness evaluation will be conducted to produce policy relevant guidance for the Thai Ministry of Public Health. The planned trial period will start in January 2020 and finish October 2021. ETHICS AND DISSEMINATION: Ethical approval has been obtained from Thailand and the UK. We will share our study data with other researchers, advertising via our publications and web presence. In particular, we are committed to sharing our findings and data with academic audiences in Thailand and other low-income and middle-income countries. TRIAL REGISTRATION NUMBER: NCT03938233.

Effectiveness of behaviour change techniques on lifestyle interventions of patients with a high risk of developing cardiovascular disease. Using a qualitative approach.

This study aimed to identify key active ingredients on the maintenance of behaviour change for lifestyle interventions of patients with a high risk of developing cardiovascular disease (CVD) who participated in a MOtiVational intErviewing InTervention (MOVE IT) randomised control trial (RCT). A process evaluation was carried out using focus groups. Twenty-six participants of the MOVE IT RCT were purposively recruited and split into six focus groups. Four groups had attended six or more sessions of the intensive phase (completers) and two groups had withdrawn before the end of the intensive phase or had not attended any sessions (non-completers). Focus groups were audio recorded, transcribed verbatim and analysed inductively using thematic analysis. Three overall themes were generated from the six focus groups: (a) long-term benefits from diet and physical activity education, (b) group versus individual structure and adherence and (c) impact on health beliefs and risk of CVD. A fourth theme was generated from the two groups of non-completers only: (d) need for professional rapport building and feedback. We found that the key active ingredients for effective behavioural change in lifestyle interventions are having well-developed rapport between facilitators and patients; and providing alternative forms of feedback to encourage maintenance of behaviour change. Furthermore, such programmes also need to have established and strong relationships with associated health professionals (i.e. the General Practitioner) to increase participation and maintenance of engagement.

Exploring healthcare professionals' perspectives of barriers and facilitators to supporting people with severe mental illness and Type 2 diabetes mellitus.

Individuals with comorbid severe mental illness (SMI) and diabetes experience an average mortality gap of 20 years compared to individuals without these conditions. There has been some recognition by policies that there is a gap between mental healthcare and physical healthcare for SMI patients. Despite this, there are still no defined care pathways for individuals with SMI and diabetes. The aim of this study was to explore healthcare professionals' (HCPs) perspectives of barriers and solutions to supporting people with SMI and diabetes. HCPs in areas of South London were invited to attend a workshop event to discuss their views of SMI and diabetes pathways. Fifty participants were recruited using the Local Care Network. HCPs included GPs, mental health nurses, psychiatrists, diabetologists and care co-ordinators. The main themes were as follows: (a) poor coordination of care and care planning between services; (b) key techniques to improve integrated care; (c) perceived difficulties achieving better care and (d) supporting patient empowerment. The findings and recommendations from this workshop may provide some insight into key factors in providing and improving integrated SMI and diabetes care for patients in South East London and further afield.