Intermediate hyperglycaemia, diabetes and blood pressure in rural Bangladesh: five-year post-randomisation follow-up of the DMagic cluster-randomised controlled trial.

Background: The DMagic trial showed that participatory learning and action (PLA) community mobilisation delivered through facilitated community groups, and mHealth voice messaging interventions improved diabetes knowledge in Bangladesh and the PLA intervention reduced diabetes occurrence. We assess intervention effects three years after intervention activities stopped. Methods: Five years post-randomisation, we conducted a cross-sectional survey among a random sample of adults aged ≥30-years living in the 96 DMagic villages, and a cohort of individuals identified with intermediate hyperglycaemia at the start of the DMagic trial in 2016. Primary outcomes were: 1) the combined prevalence of intermediate hyperglycaemia and diabetes; 2) five-year cumulative incidence of diabetes among the 2016 cohort of individuals with intermediate hyperglycaemia. Secondary outcomes were: weight, BMI, waist and hip circumferences, blood pressure, knowledge and behaviours. Primary analysis compared outcomes at the cluster level between intervention arms relative to control. Findings: Data were gathered from 1623 (82%) of the randomly selected adults and 1817 (87%) of the intermediate hyperglycaemia cohort. 2018 improvements in diabetes knowledge in mHealth clusters were no longer observable in 2021. Knowledge remains significantly higher in PLA clusters relative to control but no difference in primary outcomes of intermediate hyperglycaemia and diabetes prevalence (OR (95%CI) 1.23 (0.89, 1.70)) or five-year incidence of diabetes were observed (1.04 (0.78, 1.40)). Hypertension (0.73 (0.54, 0.97)) and hypertension control (2.77 (1.34, 5.75)) were improved in PLA clusters relative to control. Interpretation: PLA intervention effect on intermediate hyperglycaemia and diabetes was not sustained at 3 years after intervention end, but benefits in terms of blood pressure reduction were observed. Funding: Medical Research Council UK: MR/M016501/1 (DMagic trial); MR/T023562/1 (DClare study), under the Global Alliance for Chronic Diseases (GACD) Diabetes and Scale-up Programmes, respectively.

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.

Changes in non-communicable diseases, diet and exercise in a rural Bangladesh setting before and after the first wave of COVID-19.

Prevalence of non-communicable diseases (NCDs) is high in rural Bangladesh. Given the complex multi-directional relationships between NCDs, COVID-19 infections and control measures, exploring pandemic impacts in this context is important. We conducted two cross-sectional surveys of adults ≥30-years in rural Faridpur district, Bangladesh, in February to March 2020 (survey 1, pre-COVID-19), and January to March 2021 (survey 2, post-lockdown). A new random sample of participants was taken at each survey. Anthropometric measures included: blood pressure, weight, height, hip and waist circumference and fasting and 2-hour post-glucose load blood glucose. An interviewer-administered questionnaire included: socio-demographics; lifestyle and behavioural risk factors; care seeking; self-rated health, depression and anxiety assessments. Differences in NCDs, diet and exercise were compared between surveys using chi2 tests, logistic and linear regression; sub-group analyses by gender, age and socio-economic tertiles were conducted. We recruited 950 (72.0%) participants in survey 1 and 1392 (87.9%) in survey 2. The percentage of the population with hypertension increased significantly from 34.5% (95% CI: 30.7, 38.5) to 41.5% (95% CI: 38.2, 45.0; p-value = 0.011); the increase was more pronounced in men. Across all measures of self-reported health and mental health, there was a significant improvement between survey 1 and 2. For self-rated health, we observed a 10-point increase (71.3 vs 81.2, p-value = 0.005). Depression reduced from 15.3% (95% CI: 8.4, 26.1) to 6.0% (95% CI: 2.7, 12.6; p-value = 0.044) and generalised anxiety from 17.9% (95% CI: 11.3, 27.3) to 4.0% (95% CI: 2.0, 7.6; p-value<0.001). No changes in fasting blood glucose, diabetes status, BMI or abdominal obesity were observed. Our findings suggest both positive and negative health outcomes following COVID-19 lockdown in a rural Bangladeshi setting, with a concerning increase in hypertension. These findings need to be further contextualised, with prospective assessments of indirect effects on physical and mental health and care-seeking.

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.

Participatory learning and action cycles with women's groups to prevent neonatal death in low-resource settings: A multi-country comparison of cost-effectiveness and affordability.

WHO recommends participatory learning and action cycles with women's groups as a cost-effective strategy to reduce neonatal deaths. Coverage is a determinant of intervention effectiveness, but little is known about why cost-effectiveness estimates vary significantly. This article reanalyses primary cost data from six trials in India, Nepal, Bangladesh and Malawi to describe resource use, explore reasons for differences in costs and cost-effectiveness ratios, and model the cost of scale-up. Primary cost data were collated, and costing methods harmonized. Effectiveness was extracted from a meta-analysis and converted to neonatal life-years saved. Cost-effectiveness ratios were calculated from the provider perspective compared with current practice. Associations between unit costs and cost-effectiveness ratios with coverage, scale and intensity were explored. Scale-up costs and outcomes were modelled using local unit costs and the meta-analysis effect estimate for neonatal mortality. Results were expressed in 2016 international dollars. The average cost was $203 (range: $61-$537) per live birth. Start-up costs were large, and spending on staff was the main cost component. The cost per neonatal life-year saved ranged from $135 to $1627. The intervention was highly cost-effective when using income-based thresholds. Variation in cost-effectiveness across trials was strongly correlated with costs. Removing discounting of costs and life-years substantially reduced all cost-effectiveness ratios. The cost of rolling out the intervention to rural populations ranges from 1.2% to 6.3% of government health expenditure in the four countries. Our analyses demonstrate the challenges faced by economic evaluations of community-based interventions evaluated using a cluster randomized controlled trial design. Our results confirm that women's groups are a cost-effective and potentially affordable strategy for improving birth outcomes among rural populations.

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 .

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.

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.

Growth and body composition of children aged 2-4 years after exposure to community mobilisation women's groups in Bangladesh.

BACKGROUND: Women's groups interventions in Bangladesh reduced neonatal deaths by 38% and improved hygienic delivery, newborn care practices and breast feeding. We explore the longer-term impact of exposure to women's groups during pregnancy on child growth at 2-4 years. METHODS: We performed a cross-sectional survey of child anthropometric measures (analysed as z-scores) among children born to women who had participated in the women's groups interventions while pregnant, compared with an age-matched and sex-matched sample of children born to control mothers. Results were stratified by maternal body mass index (BMI) and adjusted for possible confounding effects of maternal education, household asset ownership and, in a separate model, mother-child height difference, a proxy for improved survival of small babies in intervention groups. RESULTS: Data were obtained from 2587 mother-child pairs (91% response). After adjustment for asset ownership, maternal education and potential survival effects, children whose mothers were exposed to the women's group intervention had higher head (0.16 (0.04 to 0.28)), mid-upper arm (0.11 (0.04 to 0.19)), abdominal (0.13 (0.00 to 0.26)) and chest (0.18 (0.08 to 0.29)) circumferences than their control counterparts. No significant differences in subcutaneous fat (subscapular and triceps skinfold thickness) were observed. When stratified by maternal BMI, intervention children had higher weight, BMI and circumferences, and these effects decreased with increasing maternal BMI category. CONCLUSIONS: Women's groups appear to have had a lasting, positive impact on child anthropometric outcomes, with most significant results clustering in children of underweight mothers. Observed differences are likely to be of public health significance in terms of the nutritional and metabolic development of children.

Intrapartum-related stillbirths and neonatal deaths in rural bangladesh: a prospective, community-based cohort study.

OBJECTIVE: Using a low-cost community surveillance system, we aimed to estimate intrapartum stillbirth and intrapartum-related neonatal death rates for a low-income community setting. PATIENTS AND METHODS: From 2005 to 2008, information on all deliveries in 18 unions of 3 districts of Bangladesh was ascertained by using traditional birth attendants as key informants. Outcomes were measured using a structured interview with families 6 weeks after delivery. RESULTS: We ascertained information on 31 967 deliveries, of which 26 173 (82%) occurred at home. For home deliveries, the mean cluster-adjusted stillbirth rate was 26 (95% confidence interval [CI[: 24-28) per 1000 births, and the perinatal mortality rate was 51 per 1000 births (95% CI: 47-55). The NMR was 33 per 1000 live births (95% CI: 30-37). There were 3186 (12.5%) home-born infants who did not breathe immediately. Of these, 53% underwent some form of resuscitation. Of 1435 infants who were in poor condition at 5 minutes (5% of all deliveries), 286 (20%) died; 35% of all causes of neonatal mortality. Of 201 fresh stillbirths, 40 (14%) of the infants had major congenital abnormalities. Our estimate of the intrapartum-related crude mortality rate among home-born infants is 17 in 1000 (95% CI: 16-19), 6 in 1000 stillborn and 11 in 1000 neonatal deaths after difficulties at birth. CONCLUSIONS: Difficulty initiating respiration among infants born at home in rural Bangladesh is common, and resuscitation is frequently attempted. Newborns who remain in poor condition at 5 minutes have a 20% mortality rate. Evaluation of resuscitation methods, early intervention trials including antibiotic regimes, and follow-up studies of survivors of community-based resuscitation are needed.