Evaluating a digital intervention for prevention of type 2 diabetes: protocol for a cluster-randomised controlled trial in urban and rural India.

IF 3.6 2区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH
Parizad Avari, Harish Ranjani, Sharma Nitika, Narayanaswamy Jagannathan, Viswanathan Mohan, Ashutosh Yadav, Menka Loomba, Akansha Tyagi, Nick Oliver, Vinitaa Jha, John Campbell Chambers, Jonathan Valabhji, Ranjit Mohan Anjana
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引用次数: 0

Abstract

Background: The rising prevalence of diabetes, particularly in low- and middle-income countries, highlights an urgent need for innovative approaches to prevention. India faces a growing burden of type 2 diabetes (T2D), placing considerable strain on affected individuals and healthcare systems. This study aims to evaluate the effectiveness of a digital intervention designed to prevent T2D in individuals with pre-diabetes in India.

Methods: A total of 3,240 individuals with pre-diabetes will be recruited across urban and rural settings in Tamil Nadu and Delhi. Participants will be cluster randomised to either the digital intervention group or the control group (usual standard of care). Clusters will comprise of wards in urban areas and villages in rural areas. Initial screening will be conducted using the Indian Diabetes Risk Score (IDRS) ≥ 30 and/or a random capillary blood glucose level ≥ 110 mg/dL. Final recruitment into the study will be based on capillary oral glucose tolerance testing (OGTT) and/or HbA1c levels. The primary outcome is incidence of T2D at 24 months, and secondary outcomes are cardiometabolic events, lifestyle and behavioural factors, and cost effectiveness of digital interventions. The study is registered with the Central Trials Registry of India (CTRI/2022/02/040650).

Discussion: This protocol paper details the comprehensive study design aimed at evaluating the effectiveness of a digital intervention to prevent T2D in India. If effective, the study will provide important insights into the use of technology in resource-constrained settings and offer a scalable solution for diabetes prevention. The findings could also inform future interventions and policies aimed at curbing the rising burden of diabetes in low- and middle-income countries.

Trial registration: CTRI/2022/02/040650 (registration date: 28.02.2022).  https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NjE2NzE=&Enc=&userName=.

评估数字干预预防2型糖尿病:印度城市和农村集群随机对照试验方案
背景:糖尿病患病率不断上升,特别是在低收入和中等收入国家,这突出表明迫切需要创新的预防方法。印度面临着日益加重的2型糖尿病(T2D)负担,给受影响的个人和卫生保健系统带来了相当大的压力。本研究旨在评估数字干预的有效性,旨在预防印度糖尿病前期个体的T2D。方法:将在泰米尔纳德邦和德里的城市和农村环境中招募总共3240名糖尿病前期患者。参与者将被随机分组到数字干预组或对照组(通常的护理标准)。集群将包括城市地区的病房和农村地区的村庄。初始筛查将使用印度糖尿病风险评分(IDRS)≥30和/或随机毛细血管血糖水平≥110 mg/dL进行。最终纳入研究将基于毛细血管口服葡萄糖耐量试验(OGTT)和/或HbA1c水平。主要结果是24个月时T2D的发病率,次要结果是心脏代谢事件、生活方式和行为因素以及数字干预的成本效益。该研究已在印度中央试验登记处注册(CTRI/2022/02/040650)。讨论:本协议文件详细介绍了旨在评估印度数字干预预防T2D有效性的综合研究设计。如果有效,该研究将为在资源受限环境下使用技术提供重要见解,并为糖尿病预防提供可扩展的解决方案。这些发现还可以为未来的干预措施和政策提供信息,旨在遏制中低收入国家日益增加的糖尿病负担。试验注册:CTRI/2022/02/040650(注册日期:28.02.2022)。https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NjE2NzE=&Enc=&userName=。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
BMC Public Health
BMC Public Health 医学-公共卫生、环境卫生与职业卫生
CiteScore
6.50
自引率
4.40%
发文量
2108
审稿时长
1 months
期刊介绍: BMC Public Health is an open access, peer-reviewed journal that considers articles on the epidemiology of disease and the understanding of all aspects of public health. The journal has a special focus on the social determinants of health, the environmental, behavioral, and occupational correlates of health and disease, and the impact of health policies, practices and interventions on the community.
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