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Cluster randomised controlled trial of a peer-led lifestyle intervention program: study protocol for the Kerala diabetes prevention program

机译：由同伴主导的生活方式干预计划的整群随机对照试验：喀拉拉邦糖尿病预防计划的研究方案

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Background India currently has more than 60 million people with Type 2 Diabetes Mellitus (T2DM) and this is predicted to increase by nearly two-thirds by 2030. While management of those with T2DM is important, preventing or delaying the onset of the disease, especially in those individuals at ‘high risk’ of developing T2DM, is urgently needed, particularly in resource-constrained settings. This paper describes the protocol for a cluster randomised controlled trial of a peer-led lifestyle intervention program to prevent diabetes in Kerala, India. Methods/design A total of 60 polling booths are randomised to the intervention arm or control arm in rural Kerala, India. Data collection is conducted in two steps. Step 1 (Home screening): Participants aged 30–60?years are administered a screening questionnaire. Those having no history of T2DM and other chronic illnesses with an Indian Diabetes Risk Score value of ≥60 are invited to attend a mobile clinic (Step 2). At the mobile clinic, participants complete questionnaires, undergo physical measurements, and provide blood samples for biochemical analysis. Participants identified with T2DM at Step 2 are excluded from further study participation. Participants in the control arm are provided with a health education booklet containing information on symptoms, complications, and risk factors of T2DM with the recommended levels for primary prevention. Participants in the intervention arm receive: (1) eleven peer-led small group sessions to motivate, guide and support in planning, initiation and maintenance of lifestyle changes; (2) two diabetes prevention education sessions led by experts to raise awareness on T2DM risk factors, prevention and management; (3) a participant handbook containing information primarily on peer support and its role in assisting with lifestyle modification; (4) a participant workbook to guide self-monitoring of lifestyle behaviours, goal setting and goal review; (5) the health education booklet that is given to the control arm. Follow-up assessments are conducted at 12 and 24?months. The primary outcome is incidence of T2DM. Secondary outcomes include behavioural, psychosocial, clinical, and biochemical measures. An economic evaluation is planned. Discussion Results from this trial will contribute to improved policy and practice regarding lifestyle intervention programs to prevent diabetes in India and other resource-constrained settings. Trial registration Australia and New Zealand Clinical Trials Registry: ACTRN12611000262909 .
机译：背景技术印度目前有超过6000万人患有2型糖尿病（T2DM），预计到2030年将增加近三分之二。尽管对T2DM的管理很重要，但要预防或延缓该病的发作，尤其是迫切需要那些处于发展T2DM高风险人群中，尤其是在资源紧张的环境中。本文介绍了一项在印度喀拉拉邦开展的由同伴主导的生活方式干预计划的集群随机对照试验的协议，该试验旨在预防糖尿病。方法/设计在印度喀拉拉邦农村地区，总共有60个投票站被随机分配给干预部门或控制部门。数据收集分两个步骤进行。第1步（家庭筛查）：向30至60岁的参与者进行筛查问卷调查。那些没有T2DM病史和其他慢性病且印度糖尿病风险评分值≥60的患者被邀请去流动诊所就诊（第2步）。在流动诊所，参与者完成问卷调查，进行物理测量并提供血液样本用于生化分析。在第2步中以T2DM身份识别的参与者不参与进一步的研究。向对照组的参与者提供了一本健康教育手册，其中包含有关T2DM的症状，并发症和危险因素的信息，并推荐一级预防的水平。干预部门的参与者将收到：（1）11个由同伴主导的小组会议，以激励，指导和支持生活方式的规划，发起和维持; （2）由专家主持的两次糖尿病预防教育会议，以提高人们对T2DM危险因素，预防和管理的认识; （3）参与者手册，其中主要包含同伴支持及其在改变生活方式方面的作用的信息; （4）参加者工作手册，以指导生活方式行为的自我监测，目标设定和目标审查; （5）发放给控制部门的健康教育手册。随访评估在12和24个月进行。主要结局是2型糖尿病的发生率。次要结果包括行为，心理，临床和生化指标。计划进行经济评估。讨论的结果该试验的结果将有助于改善生活方式干预计划的政策和实践，以预防印度和其他资源紧张地区的糖尿病。试验注册澳大利亚和新西兰临床试验注册：ACTRN12611000262909。

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