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

Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycaemia in Bangladesh (DMagic): a cluster-randomised controlled trial
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DOI:
10.1016/s2213-8587(19)30001-4
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发表时间:
2019-03-01
影响因子:
44.5
通讯作者:
Azad, Kishwar
Azad, Kishwar
中科院分区:
医学1区
文献类型:
--
作者:
Fottrell, Edward;Ahmed, Naveed;Azad, Kishwar

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背景:需要制定战略来预防和控制2型糖尿病和中度高血糖,这两种疾病共同影响着孟加拉国大约三分之一的成年人。我们的目的是评估移动健康和社区动员对孟加拉国农村普通成年人中中度高血糖和糖尿病患病率的影响,并评估这些干预措施对研究人群中中度高血糖人群中2型糖尿病发病率的影响。DMagic是一项在孟加拉国96个村庄(人口约12.5万)进行的参与性社区动员、移动健康手机短信和常规护理(对照)的三组、集群随机试验。社区动员包括18个每月小组会议,由非专业人员主持,采用以糖尿病预防和控制为重点的参与式学习和行动(PLA)周期。移动健康在14个月的时间里每周发送两次语音信息,促进行为改变以降低糖尿病风险。主要结果是干预实施期结束时总体人群中2型糖尿病和中度高血糖的联合患病率,以及基线时中度高血糖队列中2型糖尿病的累计发病率。主要结果通过空腹血糖浓度和2小时口服葡萄糖耐量试验在30岁及以上成年人的横断面和确定为中度高血糖的个体队列中进行评估。患病率调查结果基于研究结束时的横断面调查;发病率的发现是基于对一组在基线时通过横断面调查确定为中度高血糖的个体进行的2年随访调查。我们还评估了干预措施的成本效益。该试验已在ISRCTN注册中心注册,注册号为ISRCTN41083256,并已完成。研究于2015年6月27日至2018年6月28日进行,解放军干预于2016年6月至2017年12月在32个村庄进行,移动健康干预于2016年10月21日至2017年12月24日在32个村庄进行。研究结束时对11454人的患病率和2100人的发病率进行了评估。研究结束时,与对照组相比,PLA组2型糖尿病和中度高血糖的联合患病率大幅降低(调整[分层、聚类和财富]优势比[aOR] 0.36[0.27-0.48]),绝对降低20.7% (95% CI 14.6-26.7)。在2470名基线时患有中度高血糖的成年人中,2100名(85%)进行了2年的随访。该队列中,PLA组的2年累计糖尿病发病率显著低于对照组(aOR为0.39,0.24-0.65),绝对发病率降低8.7%(3.5-14.0)。没有证据表明移动健康对中度高血糖和糖尿病的联合患病率(aOR为0.93,0.74-1.16)或糖尿病的发病率(aOR为1.02,0.73-1.43)有影响。PLA的增量成本-效果比为预防每例中度高血糖或2型糖尿病316美元,在中度高血糖个体中预防每例2型糖尿病6518美元。我们的数据提供了强有力的证据来支持基于PLA的社区动员在孟加拉国农村人口中预防2型糖尿病的使用。尽管提高了人们对糖尿病的认识和意识,移动健康干预并没有改变我们人群的疾病结局。在其他人群中的重复研究应该是优先考虑的。版权所有(c) 2019作者。Elsevier Ltd.出版。
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. Copyright (c) 2019 The Author(s). Published by Elsevier Ltd.