Stakeholder perceptions on scaling-up community-led interventions for prevention and control of non-communicable diseases in Bangladesh: a qualitative study.

BACKGROUND: Engaging communities is an important component of multisectoral action to address the growing burden of non-communicable diseases (NCDs) in low- and middle-income countries. We conducted research with non-communicable disease stakeholders in Bangladesh to understand how a community-led intervention which was shown to reduce the incidence of type 2 diabetes in rural Bangladesh could be scaled-up. METHODS: We purposively sampled any actor who could have an interest in the intervention, or that could affect or be affected by the intervention. We interviewed central level stakeholders from donor agencies, national health policy levels, public, non-governmental, and research sectors to identify scale-up mechanisms. We interviewed community health workers, policy makers, and non-governmental stakeholders, to explore the feasibility and acceptability of implementing the suggested mechanisms. We discussed scale-up options in focus groups with community members who had attended a community-led intervention. We iteratively developed our data collection tools based on our analysis and re-interviewed some participants. We analysed the data deductively using a stakeholder analysis framework, and inductively from codes identified in the data. RESULTS: Despite interest in addressing NCDs, there was a lack of a clear community engagement strategy at the government level, and most interventions have been implemented by non-governmental organisations. Many felt the Ministry of Health and Family Welfare should lead on community engagement, and NCD screening and referral has been added to the responsibilities of community health workers and health volunteers. Yet there remains a focus on reproductive health and NCD diagnosis and referral instead of prevention at the community level. There is potential to engage health volunteers in community-led interventions, but their present focus on engaging women for reproductive health does not fit with community needs for NCD prevention. CONCLUSIONS: Research highlighted the need for a preventative community engagement strategy to address NCDs, and the potential to utilise existing cadres to scale-up community-led interventions. It will be important to work with key stakeholders to address gender issues and ensure flexibility and responsiveness to community concerns. We indicate areas for further implementation research to develop scaled-up models of community-led interventions to address NCDs.

Care-seeking and managing diabetes in rural Bangladesh: a mixed methods study.

BACKGROUND: Type 2 diabetes mellitus poses a major health challenge worldwide and in low-income countries such as Bangladesh, however little is known about the care-seeking of people with diabetes. We sought to understand the factors that affect care-seeking and diabetes management in rural Bangladesh in order to make recommendations as to how care could be better delivered. METHODS: Survey data from a community-based random sample of 12,047 adults aged 30 years and above identified 292 individuals with a self-reported prior diagnosis of diabetes. Data on health seeking practices regarding testing, medical advice, medication and use of non-allopathic medicine were gathered from these 292 individuals. Qualitative semi-structured interviews and focus group discussions with people with diabetes and semi-structured interviews with health workers explored care-seeking behaviour, management of diabetes and perceptions on quality of care. We explore quality of care using the WHO model with the following domains: safe, effective, patient-centred, timely, equitable and efficient. RESULTS: People with diabetes who are aware of their diabetic status do seek care but access, particularly to specialist diabetes services, is hindered by costs, time, crowded conditions and distance. Locally available services, while more accessible, lack infrastructure and expertise. Women are less likely to be diagnosed with diabetes and attend specialist services. Furthermore costs of care and dissatisfaction with health care providers affect medication adherence. CONCLUSION: People with diabetes often make a trade-off between seeking locally available accessible care and specialised care which is more difficult to access. It is vital that health services respond to the needs of patients by building the capacity of local health providers and consider practical ways of supporting diabetes care. TRIAL REGISTRATION: ISRCTN41083256 . Registered on 30/03/2016.

Participatory learning and action to address type 2 diabetes in rural Bangladesh: a qualitative process evaluation.

BACKGROUND: Diabetes is 7th largest cause of death worldwide, and prevalence is increasing rapidly in low-and middle-income countries. There is an urgent need to develop and test interventions to prevent and control diabetes and develop the theory about how such interventions can be effective. We conducted a participatory learning and action (PLA) intervention with community groups in rural Bangladesh which was evaluated through a cluster randomised controlled trial. There was a large reduction in the combined prevalence of type 2 diabetes and intermediate hyperglycaemia in the PLA group compared with the control group. We present findings from qualitative process evaluation research to explore how this intervention was effective. METHODS: We conducted group interviews and focus group discussions using photovoice with purposively sampled group attenders and non-attenders, and intervention implementers. Data were collected before the trial analysis. We used inductive content analysis to generate theory from the data. RESULTS: The intervention increased the health literacy of individuals and communities - developing their knowledge, capacity and self-confidence to enact healthy behaviours. Community, household and individual capacity increased through social support and social networks, which then created an enabling community context, further strengthening agency and enabling community action. This increased opportunities for healthy behaviour. Community actions addressed lack of awareness about diabetes, gendered barriers to physical activity and lack of access to blood glucose testing. The interaction between the individual, household, and community contexts amplified change, and yet there was limited engagement with macro level, or 'state', barriers to healthy behaviour. CONCLUSIONS: The participatory approach enabled groups to analyse how context affected their ability to have healthy behaviours and participants engaged with issues as a community in the ways that they felt comfortable. We suggest measuring health literacy and social networks in future interventions and recommend specific capacity strengthening to develop public accountability mechanisms and health systems strengthening to complement community-based interventions. TRIAL REGISTRATION: Registered at ISRCTN on 30th March 2016 (Retrospectively Registered) Registration number: ISRCTN41083256 .

Effectiveness of a multi-country implementation-focused network on quality of care: Delivery of interventions and processes for improved maternal, newborn and child health outcomes.

The Network for Improving Quality of Care for Maternal, Newborn and Child Health (QCN) aims to work through learning, action, leadership and accountability. We aimed to evaluate the effectiveness of QCN in these four areas at the global level and in four QCN countries: Bangladesh, Ethiopia, Malawi and Uganda. This mixed method evaluation comprised 2-4 iterative rounds of data collection between 2019-2022, involving stakeholder interviews, hospital observations, QCN members survey, and document review. Qualitative data was analysed using a coding framework developed from underlying theories on network effectiveness, behaviour change, and QCN proposed theory of change. Survey data capturing respondents' perception of QCN was analysed with descriptive statistics. The QCN global level, led by the WHO secretariat, was effective in bringing together network countries' governments and global actors via providing online and in-person platforms for communication and learning. In-country, various interventions were delivered in 'learning districts', however often separately by different partners in different locations, and pandemic-disrupted. Governance structures for quality of care were set-up, some preceding QCN, and were found to be stronger and better (though often externally) resourced at national than local levels. Awareness of operational plans and network activities differed between countries, was lower at local than national levels, but increased from 2019 to 2022. Engagement with, and value of, QCN was perceived to be higher in Uganda and Bangladesh than in Malawi or Ethiopia. Capacity building efforts were implemented in all countries-yet often dependent on implementing partners and donors. QCN stakeholders agreed 15 core monitoring indicators though data collection was challenging, especially for indicators requiring new or parallel systems. Accountability initiatives remained nascent in 2022. Global and national leadership elements of QCN have been most effective to date, with action, learning and accountability more challenging, partner or donor dependent, remaining to be scaled-up, and pandemic-disrupted.

Individual, organizational and system circumstances, and the functioning of a multi-country implementation-focused network for maternal, newborn and child health: Bangladesh, Ethiopia, Malawi, and Uganda.

Better policies, investments, and programs are needed to improve the integration and quality of maternal, newborn, and child health services. Previously, partnerships and collaborations that involved multiple countries with a unified aim have been observed to yield positive results. Since 2017, the WHO and partners have hosted the Quality of Care Network [QCN], a multi-country implementation network focused on improving maternal, neonatal, and child health care. In this paper, we examine the functionality of QCN in different contexts. We focus on implementation circumstances and contexts in four network countries: Bangladesh, Ethiopia, Malawi, and Uganda. In each country, the study was conducted over several consecutive rounds between 2019-2022, employing 227 key informant interviews with major stakeholders and members of the network countries, and 42 facility observations. The collected data were coded using Nvivo-12 software and categorized thematically. The study showed that individual, organizational and system-level circumstances all played an important role in shaping implementation success in network countries, but that these levels were inter-linked. Systems that enabled leadership, motivated and trained staff, and created a positive culture of data use were critical for policy-making including addressing financing issues-to the day-to-day practice improvement at the front line. Some characteristics of QCN actively supported this, for example, shared learning forums for continuous learning, a focus on data and tracking progress, and emphasising the importance of coordinated efforts towards a common goal. However, inadequate system financing and capacity also hampered network functioning, especially in the face of external shocks.

Opportunities to sustain a multi-country quality of care network: Lessons on the actions of four countries Bangladesh, Ethiopia, Malawi, and Uganda.

The Quality of Care Network (QCN) is a global initiative that was established in 2017 under the leadership of WHO in 11 low-and- middle income countries to improve maternal, newborn, and child health. The vision was that the Quality of Care Network would be embedded within member countries and continued beyond the initial implementation period: that the Network would be sustained. This paper investigated the experience of actions taken to sustain QCN in four Network countries (Bangladesh, Ethiopia, Malawi, and Uganda) and reports on lessons learned. Multiple iterative rounds of data collection were conducted through qualitative interviews with global and national stakeholders, and non-participatory observation of health facilities and meetings. A total of 241 interviews, 42 facility and four meeting observations were carried out. We conducted a thematic analysis of all data using a framework approach that defined six critical actions that can be taken to promote sustainability. The analysis revealed that these critical actions were present with varying degrees in each of the four countries. Although vulnerabilities were observed, there was good evidence to support that actions were taken to institutionalize the innovation within the health system, to motivate micro-level actors, plan opportunities for reflection and adaptation from the outset, and to support strong government ownership. Two actions were largely absent and weakened confidence in future sustainability: managing financial uncertainties and fostering community ownership. Evidence from four countries suggested that the QCN model would not be sustained in its original format, largely because of financial vulnerability and insufficient time to embed the innovation at the sub-national level. But especially the efforts made to institutionalize the innovation in existing systems meant that some characteristics of QCN may be carried forward within broader government quality improvement initiatives.

Community participatory learning and action cycle groups to reduce type 2 diabetes in Bangladesh (D:Clare): an updated study protocol for a parallel arm cluster randomised controlled trial.

The "Diabetes: Community-led Awareness, Response and Evaluation" (D:Clare) trial aims to scale up and replicate an evidence-based participatory learning and action cycle intervention in Bangladesh, to inform policy on population-level T2DM prevention and control.The trial was originally designed as a stepped-wedge cluster randomised controlled trial, with the interventions running from March 2020 to September 2022. Twelve clusters were randomly allocated (1:1) to implement the intervention at months 1 or 12 in two steps, and evaluated through three cross-sectional surveys at months 1, 12 and 24. However, due to the COVID-19 pandemic, we suspended project activities on the 20th of March 2020. As a result of the changed risk landscape and the delays introduced by the COVID-19 pandemic, we changed from the stepped-wedge design to a wait-list parallel arm cluster RCT (cRCT) with baseline data. We had four key reasons for eventually agreeing to change designs: equipoise, temporal bias in exposure and outcomes, loss of power and time and funding considerations.Trial registration ISRCTN42219712 . Registered on 31 October 2019.

Individual interactions in a multi-country implementation-focused quality of care network for maternal, newborn and child health: A social network analysis.

The Network for Improving Quality of Care for Maternal, Newborn and Child Health (QCN) was established to build a cross-country platform for joint-learning around quality improvement implementation approaches to reduce mortality. This paper describes and explores the structure of the QCN in four countries and at global level. Using Social Network Analysis (SNA), this cross-sectional study maps the QCN networks at global level and in four countries (Bangladesh, Ethiopia, Malawi and Uganda) and assesses the interactions among actors involved. A pre-tested closed-ended structured questionnaire was completed by 303 key actors in early 2022 following purposeful and snowballing sampling. Data were entered into an online survey tool, and exported into Microsoft Excel for data management and analysis. This study received ethical approval as part of a broader evaluation. The SNA identified 566 actors across the four countries and at global level. Bangladesh, Malawi and Uganda had multiple-hub networks signifying multiple clusters of actors reflecting facility or district networks, whereas the network in Ethiopia and at global level had more centralized networks. There were some common features across the country networks, such as low overall density of the network, engagement of actors at all levels of the system, membership of related committees identified as the primary role of actors, and interactions spanning all types (learning, action and information sharing). The most connected actors were facility level actors in all countries except Ethiopia, which had mostly national level actors. The results reveal the uniqueness and complexity of each network assessed in the evaluation. They also affirm the broader qualitative evaluation assessing the nature of these networks, including composition and leadership. Gaps in communication between members of the network and limited interactions of actors between countries and with global level actors signal opportunities to strengthen QCN.

Influences on policy-formulation, decision-making, organisation and management for maternal, newborn and child health in Bangladesh, Ethiopia, Malawi and Uganda: The roles and legitimacy of a multi-country network.

The Network for Improving Quality of Care for Maternal, Newborn and Child Health (QCN) is intended to facilitate learning, action, leadership and accountability for improving quality of care in member countries. This requires legitimacy-a network's right to exert power within national contexts. This is reflected, for example, in a government's buy-in and perceived ownership of the work of the network. During 2019-2022 we conducted iterative rounds of stakeholder interviews, observations of meetings, document review, and hospital observations in Bangladesh, Ethiopia, Malawi, Uganda and at the global level. We developed a framework drawing on three models: Tallberg and Zurn which conceptualizes legitimacy of international organisations dependent on their features, the legitimation process and beliefs of audiences; Nasiritousi and Faber, which looks at legitimacy in terms of problem, purpose, procedure, and performance of institutions; Sanderink and Nasiritousi, to characterize networks in terms of political, normative and cognitive interactions. We used thematic analysis to characterize, compare and contrast institutional interactions in a cross-case synthesis to determine salient features. Political and normative interactions were favourable within and between countries and at global level since collective decisions, collaborative efforts, and commitment to QCN goals were observed at all levels. Sharing resources and common principles were not common between network countries, indicating limits of the network. Cognitive interactions-those related to information sharing and transfer of ideas-were more challenging, with the bi-directional transfer, synthesis and harmonization of concepts and methods, being largely absent among and within countries. These may be required for increasing government ownership of QCN work, the embeddedness of the network, and its legitimacy. While we find evidence supporting the legitimacy of QCN from the perspective of country governments, further work and time are required for governments to own and embed the work of QCN in routine care.

Equity impact of participatory learning and action community mobilisation and mHealth interventions to prevent and control type 2 diabetes and intermediate hyperglycaemia in rural Bangladesh: analysis of a cluster randomised controlled trial.

BACKGROUND: A cluster randomised trial of mHealth and participatory learning and action (PLA) community mobilisation interventions showed that PLA significantly reduced the prevalence of intermediate hyperglycaemia and type 2 diabetes mellitus (T2DM) and the incidence of T2DM among adults in rural Bangladesh; mHealth improved knowledge but showed no effect on glycaemic outcomes. We explore the equity of intervention reach and impact. METHODS: Intervention reach and primary outcomes of intermediate hyperglycaemia and T2DM were assessed through interview surveys and blood fasting glucose and 2-hour oral glucose tolerance tests among population-based samples of adults aged ≥30 years. Age-stratified, gender-stratified and wealth-stratified intervention effects were estimated using random effects logistic regression. RESULTS: PLA participants were similar to non-participants, though female participants were younger and more likely to be married than female non-participants. Differences including age, education, wealth and marital status were observed between individuals exposed and those not exposed to the mHealth intervention.PLA reduced the prevalence of T2DM and intermediate hyperglycaemia in all age, gender and wealth strata. Reductions in 2-year incidence of T2DM of at least 51% (0.49, 95% CI 0.26 to 0.92) were observed in all strata except among the oldest and least poor groups. mHealth impact on glycaemic outcomes was observed only among the youngest group, where a 47% reduction in the 2-year incidence of T2DM was observed (0.53, 95% CI 0.28 to 1.00). CONCLUSION: Large impacts of PLA across all strata indicate a highly effective and equitable intervention. mHealth may be more suitable for targeting higher risk, younger populations. TRIAL REGISTRATION NUMBER: ISRCTN41083256.

Learning from a diabetes mHealth intervention in rural Bangladesh: what worked, what did not and what next?

There is an urgent need for population-based interventions to slow the growth of the diabetes epidemic in low-and middle-income countries. We tested the effectiveness of a population-based mHealth voice messaging intervention for T2DM prevention and control in rural Bangladesh through a cluster randomised controlled trial. mHealth improved knowledge and awareness about T2DM but there was no detectable effect on T2DM occurrence. We conducted mixed-methods research to understand this result. Exposure to messages was limited by technological faults, high frequency of mobile phone number changes, message fatigue and (mis)perceptions that messages were only for those who had T2DM. Persistent social norms, habits and desires made behaviour change challenging, and participants felt they would be more motivated by group discussions than mHealth messaging alone. Engagement with mHealth messages for T2DM prevention and control can be increased by (1) sending identifiable messages from a trusted source (2) using participatory design of mHealth messages to inform modelling of behaviours and increase relevance to the general population (3) enabling interactive messaging. mHealth messaging is likely to be most successful if implemented as part of a multi-sectoral, multi-component approach to address T2DM and non-communicable disease risk factors.

Visual Participatory Analysis: A Qualitative Method for Engaging Participants in Interpreting the Results of Randomized Controlled Trials of Health Interventions.

This article contributes to the field of mixed methods by introducing a new method for eliciting participant perspectives of the quantitative results of randomized controlled trials. Participants are rarely asked to interpret trial results, obscuring potentially valuable information about why a trial either succeeds or fails. We introduce a unique method called visual participatory analysis and discuss the insights gained in its use as part of a trial to prevent risk and reduce the prevalence of diabetes in Bangladesh. Findings highlight benefits such as elucidating contextualized explanations for null results and identifying causal mechanisms, as well as challenges around communicating randomized controlled trial methodologies to lay audiences. We conclude that visual participatory analysis is a valuable method to use after a trial.

Community participatory learning and action cycle groups to reduce type 2 diabetes in Bangladesh (D:Clare trial): study protocol for a stepped-wedge cluster randomised controlled trial.

BACKGROUND: An estimated 463 million people globally have diabetes, with the prevalence growing in low-and middle-income settings, such as Bangladesh. Given the need for context-appropriate interventions to prevent type 2 diabetes mellitus (T2DM), the 'Diabetes: Community-led Awareness, Response and Evaluation' (D:Clare) trial will rigorously evaluate the replication and scale-up of a participatory learning and action (PLA) cycle intervention in Bangladesh, to inform policy on population-level T2DM prevention and control. METHODS: This is a stepped-wedge cluster randomised controlled trial, with integrated process and economic evaluations, conducted from March 2020 to September 2022. The trial will evaluate a community-based four-phase PLA cycle intervention focused on prevention and control of T2DM implemented over 18 months, against a control of usual care. Twelve clusters will be randomly allocated (1:1) to implement the intervention at project month 1 or 12. The intervention will be evaluated through three cross-sectional surveys at months 1, 12 and 24. The trial will be conducted in Alfadanga Upazila, Faridpur district, with an estimated population of 120,000. Clusters are defined as administrative geographical areas, with approximately equal populations. Each of the six unions in Alfadanga will be divided into two clusters, forming 12 clusters in total. Given the risk of inter-cluster contamination, evaluation surveys will exclude villages in border areas. Participants will be randomly sampled, independently for each survey, from a population census conducted in January 2020. The primary outcome is the combined prevalence of intermediate hyperglycaemia and T2DM, measured through fasting and 2-h post-glucose load blood tests. A total of 4680 participants provide 84% power to detect a 30% reduction in the primary outcome, assuming a baseline of 30% and an ICC of 0.07. The analysis will be by intention-to-treat, comparing intervention and control periods across all clusters, adjusting for geographical clustering. DISCUSSION: This study will provide further evidence of effectiveness for community-based PLA to prevent T2DM at scale in a rural Bangladesh setting. However, we encountered several challenges in applying the stepped-wedge design to our research context, with particular consideration given to balancing seasonality, timing and number of steps and estimation of partial versus full effect. TRIAL REGISTRATION: ISRCTN: ISRCTN42219712 . Registered on 31 October 2019.

Gendered perceptions of physical activity and diabetes in rural Bangladesh: a qualitative study to inform mHealth and community mobilization interventions.

Background Diabetes prevalence is increasing rapidly in Bangladesh, and there is an urgent need to promote preventive behaviours for type 2 diabetes, such as maintaining a healthy body weight, eating healthily, avoiding tobacco and being active for 150 minutes per week. Methods We used a qualitative methodology informed by the capability, opportunity, motivation theory of behaviour change to explore the factors affecting physical activity among men and women in rural Bangladesh. We conducted semi-structured interviews and focus group discussions with 64 purposively sampled participants with and without diabetes, and five health workers. From the results of descriptive content analysis, we identified key capabilities, opportunities and motivations to engage with in our mHealth and community mobilization interventions. Results Men and women without diabetes lacked awareness about the need to remain physically active to prevent diabetes, and most felt that their activity levels were sufficient. Housework was not commonly perceived as physical activity among all respondents. These knowledge and capability gaps could be addressed through mHealth messaging and community mobilization providing information on sufficiency and types of physical activity to prevent and control diabetes. Men were physically active while working outside the home, whereas women felt unsafe and conspicuous, and were constrained by family commitments and social expectations of appropriate behaviour. Women engaged in strategies to protect their own and their family's reputations. These opportunity factors affecting physical activity indicated the need for strategies developed through participatory processes to challenge unhealthy gender norms and increase women's safety. Conclusion Formative research data can enable the development of contextually relevant interventions. Data show that mHealth interventions should consider gendered barriers to physical activity, tailoring information to meet men's and women's needs, and that community mobilization interventions should enable unhealthy, gendered community norms to be challenged. Participatory interventions can enable communities to push the boundaries of socially acceptable behaviours to increase physical activity, helping to prevent and control diabetes.

Implementation and fidelity of a participatory learning and action cycle intervention to prevent and control type 2 diabetes in rural Bangladesh.

INTRODUCTION: There is an urgent need to address the growing type 2 diabetes disease burden. 20-30% of adults in rural areas of Bangladesh have intermediate hyperglycaemia and about 10% have diabetes. We report on the implementation and fidelity of a Participatory Learning and Action (PLA) intervention, evaluated through a three-arm cluster randomised controlled trial which reduced the incidence of diabetes and intermediate hyperglycaemia in rural Bangladesh. PLA interventions have been effective in addressing population level health problems in low income country contexts, and therefore we sought to use this approach to engage communities to identify and address community barriers to prevention and control of type 2 diabetes. METHODS: We used a mixed methods approach collecting quantitative data through field reports and qualitative data through observations and focus group discussions. Through descriptive analysis, we considered fidelity to the participatory approach and implementation plans. RESULTS: One hundred twenty-two groups per month were convened by 16 facilitators and supervised by two coordinators. Groups worked through a four phase PLA cycle of problem identification, planning together, implementation and evaluation to address the risk factors for diabetes - diet, physical activity, smoking and stress. Groups reported a lack of awareness about diabetes prevention and control, the prohibitive cost of care and healthy eating, and gender barriers to exercise for women. Groups set targets to encourage physical activity, kitchen-gardening, cooking with less oil, and reduced tobacco consumption. Anti-tobacco committees operated in 90 groups. One hundred twenty-two groups arranged blood glucose testing and 74 groups organized testing twice. Forty-one women's groups established funds, and 61 communities committed not to ridicule women exercising. Experienced and committed supervisors enabled fidelity to a participatory methodology. A longer intervention period and capacity building could enable engagement with systems barriers to behaviour change. CONCLUSION: Our complex intervention was implemented as planned and is likely to be valid in similar contexts given the flexibility of the participatory approach to contextually specific barriers to prevention and control of type 2 diabetes. Fidelity to the participatory approach is key to implementing the intervention and effectively addressing type 2 diabetes in a low-income country.

Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycaemia in Bangladesh (DMagic): a cluster-randomised controlled trial.

BACKGROUND: Strategies are needed to prevent and control type 2 diabetes and intermediate hyperglycaemia, which together affect roughly a third of adults in Bangladesh. We aimed to assess the effects of mHealth and community mobilisation on the prevalence of intermediate hyperglycaemia and diabetes among the general adult population in rural Bangladesh, and to assess the effect of these interventions on the incidence of type 2 diabetes among people with intermediate hyperglycaemia within the study population. METHODS: DMagic was a three-arm, cluster-randomised trial of participatory community mobilisation, mHealth mobile phone messaging, and usual care (control) in 96 villages (population roughly 125 000) in Bangladesh. Community mobilisation involved 18 monthly group meetings, led by lay facilitators, applying a participatory learning and action (PLA) cycle focused on diabetes prevention and control. mHealth involved twice-weekly voice messages over 14 months promoting behaviour change to reduce diabetes risk. The primary outcomes were the combined prevalence of type 2 diabetes and intermediate hyperglycaemia in the overall population at the end of the intervention implementation period, and 2-year cumulative incidence of type 2 diabetes in a cohort with intermediate hyperglycaemia at baseline. Primary outcomes were assessed through fasting blood glucose concentrations and 2-h oral glucose tolerance tests among a cross-section of adults aged 30 years and older and a cohort of individuals identified with intermediate hyperglycaemia. Prevalence findings are based on a cross-sectional survey at the end of the study; incidence findings are based on 2-year follow-up survey of a cohort of individuals identified with intermediate hyperglycaemia through a cross-sectional survey at baseline. We also assessed the cost-effectiveness of the interventions. This trial is registered with the ISRCTN registry, number ISRCTN41083256, and is completed. FINDINGS: The study took place between June 27, 2015, and June 28, 2018, with the PLA intervention running in 32 villages from June, 2016, to December, 2017, and the mHealth intervention running in 32 villages from Oct 21, 2016, to Dec 24, 2017. End-of study prevalence was assessed in 11 454 individuals and incidence in 2100 individuals. There was a large reduction in the combined prevalence of type 2 diabetes and intermediate hyperglycaemia in the PLA group compared with the control group at the end of the study (adjusted [for stratification, clustering, and wealth] odds ratio [aOR] 0·36 [0·27-0·48]), with an absolute reduction of 20·7% (95% CI 14·6-26·7). Among 2470 adults with intermediate hyperglycaemia at baseline, 2100 (85%) were followed-up at 2 years. The 2-year cumulative incidence of diabetes in this cohort was significantly lower in the PLA group compared with control (aOR 0·39, 0·24-0·65), representing an absolute incidence reduction of 8·7% (3·5-14·0). There was no evidence of effect of mHealth on combined prevalence of intermediate hyperglycaemia and diabetes (aOR 0·93, 0·74-1·16) or the incidence of diabetes (1·02, 0·73-1·43). The incremental cost-effectiveness ratios for PLA were INT$316 per case of intermediate hyperglycaemia or type 2 diabetes prevented and $6518 per case of type 2 diabetes prevented among individuals with intermediate hyperglycaemia. INTERPRETATION: Our data provide strong evidence to support the use of community mobilisation based on PLA to prevent type 2 diabetes in this rural Bangladeshi population. Despite raising knowledge and awareness of diabetes, the mHealth intervention did not change disease outcomes in our population. Replication studies in other populations should be a priority. FUNDING: UK Medical Research Council.

Developing a theory-driven contextually relevant mHealth intervention.

Background: mHealth interventions have huge potential to reach large numbers of people in resource poor settings but have been criticised for lacking theory-driven design and rigorous evaluation. This paper shares the process we developed when developing an awareness raising and behaviour change focused mHealth intervention, through applying behavioural theory to in-depth qualitative research. It addresses an important gap in research regarding the use of theory and formative research to develop an mHealth intervention. Objectives: To develop a theory-driven contextually relevant mHealth intervention aimed at preventing and managing diabetes among the general population in rural Bangladesh. Methods: In-depth formative qualitative research (interviews and focus group discussions) were conducted in rural Faridpur. The data were analysed thematically and enablers and barriers to behaviour change related to lifestyle and the prevention of and management of diabetes were identified. In addition to the COM-B (Capability, Opportunity, Motivation-Behaviour) model of behaviour change we selected the Transtheoretical Domains Framework (TDF) to be applied to the formative research in order to guide the development of the intervention. Results: A six step-process was developed to outline the content of voice messages drawing on in-depth qualitative research and COM-B and TDF models. A table to inform voice messages was developed and acted as a guide to scriptwriters in the production of the messages. Conclusions: In order to respond to the local needs of a community in Bangladesh, a process of formative research, drawing on behavioural theory helped in the development of awareness-raising and behaviour change mHealth messages through helping us to conceptualise and understand behaviour (for example by categorising behaviour into specific domains) and subsequently identify specific behavioural strategies to target the behaviour.

Distribution of diabetes, hypertension and non-communicable disease risk factors among adults in rural Bangladesh: a cross-sectional survey.

BACKGROUND: Non-communicable diseases (NCDs) are increasing in low-income settings. We conducted a survey of risk factors, blood pressure and blood glucose in rural Bangladesh and assessed variations by age, sex and wealth. METHODS: We surveyed a random sample of 12 280 adults aged >30 years in 96 villages in rural Bangladesh. Fieldworkers measured blood glucose and conducted an insulin tolerance test with a repeat blood test 120 min post glucose ingestion. Blood pressure, anthropometric, socioeconomic, lifestyle and behavioural risk factors data were also collected. Data were analysed to describe the prevalence of diabetes, intermediate hyperglycaemia, hypertension and NCD risk factors by age, sex and wealth. RESULTS: Women had higher levels of overweight or obesity and lower levels of physical activity and fruit and vegetable consumption than men; 63% of men used tobacco compared with 41.3% of women. Overweight or obesity and abdominal obesity (waist to hip ratio) increased with socioeconomic status (least poor vs most poor: OR (95% CI) 3.21 (2.51 to 4.11) for men and 2.83 (2.28 to 3.52) for women). Tobacco use, passive smoke exposure and salt consumption fell with increasing socioeconomic status in both sexes. Clustering of risk factors showed more than 70% of men and women reported at least three risk factors. Women in the least poor group were 33% more likely to have three or more risk factors compared with women in the most poor group (1.33 (95% CI 1.17 to 1.58)). The combined prevalence of impaired fasting glucose, impaired glucose tolerance and diabetes was 26.1% among men and 34.9% among women, and increased with age. The prevalence of prehypertension and hypertension was 30.7% and 15.9% among men and 27.2% and 22.5% among women, with similar rising prevalence with age. CONCLUSION: NCD risk factors, hyperglycaemia and raised blood pressure are an immediate health threat in rural Bangladesh. Initiatives to improve detection, treatment and prevention strategies are needed.

Diabetes knowledge and care practices among adults in rural Bangladesh: a cross-sectional survey.

BACKGROUND: Population knowledge of how to prevent, detect and control diabetes is critical to public health initiatives to tackle the disease. We undertook a cross-sectional survey of adults in rural Bangladesh to estimate knowledge and practices related to diabetes. METHODS: In 96 villages in Faridpur district, trained fieldworkers surveyed 12 140 randomly selected men and women aged ≥30. They collected data on sociodemographic status, knowledge of diabetes and history of blood and urine glucose testing. Fasting and 2-hour post-glucose load capillary blood tests ascertained the diabetic status of respondents. Levels of knowledge and practices were analysed by sociodemographic characteristics and diabetic status. RESULTS: The population showed low levels of diabetes knowledge overall, with only one in three adults able to report any valid causes of the disease. Knowledge of diabetes causes, symptoms, complications, prevention and control was significantly associated with age, education, wealth and employment. Only 14% of respondents reported ever having had a blood glucose test and strong associations with wealth were observed (least poor relative to most poor 2.91 (2.32-3.66)). 78.4% of known diabetics (ie, with a prior diagnosis) reported that they did not monitor their blood glucose levels on at least a monthly basis. However, they had better knowledge of the causes (odds relative to normoglycaemic individuals 1.62 (1.23-2.09)), symptoms (5.17 (3.41-7.82)), complications (5.18 (3.75-7.14)), prevention (4.18 (3.04-5.74)) and control (8.43 (4.83-14.71)). CONCLUSION: Knowledge of diabetes among rural adults in Faridpur is extremely poor. Levels of diabetes testing are low and monitoring of blood glucose among known diabetics infrequent. Diabetes prevention and control efforts in this population must include large-scale awareness initiatives which focus not only on high-risk individuals but the whole population. TRIAL REGISTRATION NUMBER: ISRCTN41083256; Pre-results.

Protocol of economic evaluation and equity impact analysis of mHealth and community groups for prevention and control of diabetes in rural Bangladesh in a three-arm cluster randomised controlled trial.

INTRODUCTION: Type 2 diabetes mellitus (T2DM) is one of the leading causes of death and disability worldwide, generating substantial economic burden for people with diabetes and their families, and to health systems and national economies. Bangladesh has one of the largest numbers of adults with diabetes in the South Asian region. This paper describes the planned economic evaluation of a three-arm cluster randomised control trial of mHealth and community mobilisation interventions to prevent and control T2DM and non-communicable diseases' risk factors in rural Bangladesh (D-Magic trial). METHODS AND ANALYSIS: The economic evaluation will be conducted as a within-trial analysis to evaluate the incremental costs and health outcomes of mHealth and community mobilisation interventions compared with the status quo. The analyses will be conducted from a societal perspective, assessing the economic impact for all parties affected by the interventions, including implementing agencies (programme costs), healthcare providers, and participants and their households. Incremental cost-effectiveness ratios (ICERs) will be calculated in terms of cost per case of intermediate hyperglycaemia and T2DM prevented and cost per case of diabetes prevented among individuals with intermediate hyperglycaemia at baseline and cost per mm Hg reduction in systolic blood pressure. In addition to ICERs, the economic evaluation will be presented as a cost-consequence analysis where the incremental costs and all statistically significant outcomes will be listed separately. Robustness of the results will be assessed through sensitivity analyses. In addition, an analysis of equity impact of the interventions will be conducted. ETHICS AND DISSEMINATION: The approval to conduct the study was obtained by the University College London Research Ethics Committee (4766/002) and by the Ethical Review Committee of the Diabetic Association of Bangladesh (BADAS-ERC/EC/t5100246). The findings of this study will be disseminated through different means within academia and the wider policy sphere. TRIAL REGISTRATION NUMBER: ISRCTN41083256; Pre-results.