Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Fottrell E

PROVIDER: S-EPMC10015271 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Publications

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

Fottrell Edward E King Carina C Ahmed Naveed N Shaha Sanjit Kumer SK Morrison Joanna J Pires Malini M Kuddus Abdul A Nahar Tasmin T Haghparast-Bidgoli Hassan H Khan A K Azad AKA Azad Kishwar K

The Lancet regional health. Southeast Asia 20230301

<h4>Background</h4>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.<h4>Methods</h4>Five years post-randomisation, we conducted a cross-sectional survey among a random sample of adults aged ...[more]

PMID: 36938333

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Project description:BackgroundStrategies 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.MethodsDMagic 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.FindingsThe 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.InterpretationOur 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.FundingUK Medical Research Council.

Project description:BackgroundSanitation interventions typically result in modest increases in latrine access, and any gains in latrine access and use are often not sustained over time. Sanitation programs also rarely include child-focused interventions such as potties. We aimed to assess the sustained effect of a multi-component sanitation intervention on access to and use of latrines and child feces management tools in rural Bangladesh.MethodsWe conducted a longitudinal substudy nested within the WASH Benefits randomized controlled trial. The trial provided latrine upgrades, child potties and sani-scoops for feces removal, along with behavior change promotion to encourage use of the delivered hardware. Promotion visits to intervention recipients were frequent during the first 2 years after intervention initiation, decreased in frequency between years 2-3, and ceased after 3 years. We enrolled a random subset of 720 households from the sanitation and control arms of the trial in a substudy and visited them quarterly between 1 and 3.5 years after intervention initiation. At each visit, field staff recorded sanitation-related behaviors through spot-check observations and structured questionnaires. We assessed intervention effects on observed indicators of hygienic latrine access, potty use and sani-scoop use and investigated whether these effects were modified by duration of follow-up, ongoing behavior change promotion and household characteristics.ResultsThe intervention increased hygienic latrine access from 37% among controls to 94% in the sanitation arm (p < 0.001). Access among intervention recipients remained high 3.5 years after intervention initiation, including periods with no active promotion. Gains in access were higher among households with less education, less wealth and larger number of residents. The intervention increased availability of child potties from 29% among controls to 98% in the sanitation arm (p < 0.001). However, fewer than 25% of intervention households reported exclusive child defecation in a potty or had observed indicators of potty and sani-scoop use, and gains in potty use declined over the follow-up period, even with ongoing promotion.ConclusionOur findings from an intervention that provided free products and intensive initial behavior change promotion suggest a sustained increase in hygienic latrine access up to 3.5 years after intervention initiation but infrequent use of child feces management tools. Studies should investigate strategies to ensure sustained adoption of safe child feces management practices.

Project description:BackgroundKilled whole-cell oral cholera vaccines (OCVs) are widely used for prevention of cholera in developing countries. However, few studies have evaluated the protection conferred by internationally recommended OCVs for durations beyond 2 years of follow-up.MethodsIn this study, we followed up the participants of a cluster-randomised controlled trial for 2 years after the end of the original trial. Originally, we had randomised 90 geographical clusters in Dhaka slums in Bangladesh in equal numbers (1:1:1) to a two-dose regimen of OCV alone (targeted to people aged 1 year or older), a two-dose regimen of OCV plus a water-sanitation-hygiene (WASH) intervention, or no intervention. There was no masking of group assignment. The WASH intervention conferred little additional protection to OCV and was discontinued at 2 years of follow-up. Surveillance for severe cholera was continued for 4 years. Because of the short duration and effect of the WASH intervention, we combined the two OCV intervention groups. The primary outcomes were OCV overall protection (protection of all members of the intervention clusters) and total protection (protection of individuals who got vaccinated in the intervention clusters) against severe cholera, which we assessed by multivariable survival models appropriate for cluster-randomised trials. This trial is registered on ClinicalTrials.gov, NCT01339845.FindingsThe study was done between April 17, 2011, and Nov 1, 2015. 268 896 participants were present at the time of the first dose, with 188 206 in the intervention group and 80 690 in the control group. OCV coverage of the two groups receiving OCV was 66% (123 659 of 187 214 participants). During 4 years of follow-up, 441 first episodes of severe cholera were detected (243 episodes in the vaccinated groups and as 198 episodes in the unvaccinated group). Overall OCV protection was 36% (95% CI 19 to 49%) and total OCV protection was 46% (95% CI 32 to 58). Cumulative total vaccine protection was notably lower for people vaccinated before the age of 5 years (24%; -30 to 56) than for people vaccinated at age 5 years or older (49%; 35 to 60), although the differences in protection for the two age groups were not significant (p=0·3308). Total vaccine protection dropped notably (p=0·0115) after 3 years in children vaccinated at 1-4 years of age.InterpretationThese findings provide further evidence of long-term effectiveness of killed whole-cell OCV, and therefore further support for the use of killed whole-cell OCVs to control endemic cholera, but indicate that protection is shorter-lived in children vaccinated before the age of 5 years than in people vaccinated at the age of 5 years or older.FundingBill & Melinda Gates Foundation.TranslationFor the Bengali translation of the abstract see Supplementary Materials section.

Dataset Information

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

Background

Methods

Findings

Interpretation

Funding

Publications

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

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