Cluster randomised controlled trial of a peer-led lifestyle intervention program: study protocol for the Kerala diabetes prevention program
Cluster randomised controlled trial of a peer-led lifestyle intervention program: study protocol for the Kerala diabetes prevention program
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DOI：
10.1186/1471-2458-13-1035
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发表时间：
2013-11-04
影响因子：
4.5
通讯作者：
Oldenburg, Brian
中科院分区：
文献类型：
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作者：
Sathish, Thirunavukkarasu;Williams, Emily D.;Oldenburg, Brian
背景资料：印度目前有超过6000万人患有2型糖尿病（T2 DM），预计到2030年将增加近三分之二。虽然对T2 DM患者的管理很重要，但迫切需要预防或延迟疾病的发作，特别是在发展为T2 DM的“高风险”人群中，特别是在资源有限的环境中。本文介绍了一个群集随机对照试验的协议，同行为主导的生活方式干预计划，以防止印度喀拉拉邦的糖尿病。方法/设计：在印度农村喀拉拉邦，共有60个投票站被随机分配到干预组或对照组，数据收集分两步进行。第1步（家庭筛选）：对30-60岁的参与者进行筛选问卷调查。邀请无T2 DM和其他慢性病史且印度糖尿病风险评分值≥ 60的患者参加移动的诊所（第2步）。在移动的诊所，参与者完成问卷调查，进行身体测量，并提供血液样本进行生化分析。在第2步确定为T2 DM的受试者将被排除在进一步研究参与之外。向对照组的参与者提供健康教育小册子，其中包含有关T2 DM症状、并发症和风险因素的信息，以及一级预防的建议水平。干预组的参与者将接受：（1）11次同伴领导的小组会议，以激励、指导和支持计划、启动和维持生活方式的改变;（2）两次由专家领导的糖尿病预防教育会议，以提高对T2 DM风险因素、预防和管理的认识;（3）一份参与者手册，主要载有关于同伴支持及其在协助改变生活方式方面的作用的信息;（4）一份参与者手册，以指导自我监测生活方式行为、目标设定和目标回顾;（5）发给对照组的健康教育小册子。在12个月和24个月时进行随访评估。主要结局是T2 DM的发生率。次要结局包括行为、心理社会、临床和生化指标。经济评估planned.Discussion：本试验的结果将有助于改善政策和实践的生活方式干预计划，以防止糖尿病在印度和其他资源有限的settings.Trial注册：澳大利亚和新西兰临床试验注册：ACTRN 12611000262909。
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.