A peer-support lifestyle intervention for preventing type 2 diabetes in India: A cluster-randomized controlled trial of the Kerala Diabetes Prevention Program
A peer-support lifestyle intervention for preventing type 2 diabetes in India: A cluster-randomized controlled trial of the Kerala Diabetes Prevention Program
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DOI：
10.1371/journal.pmed.1002575
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发表时间：
2018-06-01
期刊：
影响因子：
15.8
通讯作者：
Oldenburg, Brian
中科院分区：
文献类型：
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作者：
Thankappan, Kavumpurathu R.;Sathish, Thirunavukkarasu;Oldenburg, Brian
背景关于糖尿病预防的主要疗效试验使用资源密集型方法来识别高危个体并提供生活方式干预。在低收入和中等收入国家(LMIC)更广泛地实施这些战略是不可行的。我们的目的是评估同伴支持的生活方式干预在根据简单的糖尿病风险评分确定的高危个体中预防2型糖尿病的有效性。方法和发现喀拉拉邦糖尿病预防计划是一项整群随机对照试验，在印度喀拉拉邦Trivandrum区的Neyyattinkara taluk(分区)的60个投票区(群)进行。参与者(年龄30-60岁)是那些印度糖尿病风险评分(IDRS)=60，并且在口服葡萄糖耐量试验(OGTT)中没有糖尿病的人。共有1007名参与者(47.2%为女性)参加了试验(对照组507名，干预组500名)。来自干预小组的参与者参加了为期12个月的基于社区的同行支持计划，该计划包括15个小组会议(其中12个由训练有素的非专业同行领导领导)和一系列社区活动，以支持生活方式的改变。来自控制组的参与者收到了一本教育小册子，上面有改变生活方式的建议。主要结果是通过年度OGTT诊断的24个月时糖尿病的发病率。次要结果是行为、临床和生化特征以及健康相关的生活质量(HRQOL)。共有964名(95.7%)的参与者在24个月时得到了随访。两个研究组之间的集群和参与者的基线特征相似。中位随访24个月后，对照组和干预组分别有17.1%(79/463)和14.9%(68/456)发生糖尿病(相对危险度[RR]0.88，95%可信区间0.66-1.16，p=0.36)。24个月后，与对照组相比，干预参与者在IDRS评分(平均差异：-1.5分，p=0.022)和饮酒(RR0.77，p=0.018)方面有更大的下降，而在水果和蔬菜摄入量(RR1.83，p=0.008)和HRQOL量表的身体功能评分(平均差异：3.9分，p=0.016)方面有更大的增加。提供同伴支持干预的费用为每名参与者22.5美元。没有与干预相关的不良事件。我们没有调整多重比较，这可能增加了总体的I型错误率。结论低成本的基于社区的同伴支持生活方式干预导致这一高危人群在24个月时糖尿病发病率没有显著降低。然而，一些心血管危险因素和HRQOL量表的身体功能评分有显著改善。
BackgroundThe major efficacy trials on diabetes prevention have used resource-intensive approaches to identify high-risk individuals and deliver lifestyle interventions. Such strategies are not feasible for wider implementation in low-and middle-income countries (LMICs). We aimed to evaluate the effectiveness of a peer-support lifestyle intervention in preventing type 2 diabetes among high-risk individuals identified on the basis of a simple diabetes risk score.Methods and findingsThe Kerala Diabetes Prevention Program was a cluster-randomized controlled trial conducted in 60 polling areas (clusters) of Neyyattinkara taluk (subdistrict) in Trivandrum district, Kerala state, India. Participants (age 30-60 years) were those with an Indian Diabetes Risk Score (IDRS) >= 60 and were free of diabetes on an oral glucose tolerance test (OGTT). A total of 1,007 participants (47.2% female) were enrolled (507 in the control group and 500 in the intervention group). Participants from intervention clusters participated in a 12-month community-based peer-support program comprising 15 group sessions (12 of which were led by trained lay peer leaders) and a range of community activities to support lifestyle change. Participants from control clusters received an education booklet with lifestyle change advice. The primary outcome was the incidence of diabetes at 24 months, diagnosed by an annual OGTT. Secondary outcomes were behavioral, clinical, and biochemical characteristics and health-related quality of life (HRQoL). A total of 964 (95.7%) participants were followed up at 24 months. Baseline characteristics of clusters and participants were similar between the study groups. After a median follow-up of 24 months, diabetes developed in 17.1% (79/463) of control participants and 14.9% (68/456) of intervention participants (relative risk [RR] 0.88, 95% CI 0.66-1.16, p = 0.36). At 24 months, compared with the control group, intervention participants had a greater reduction in IDRS score (mean difference: -1.50 points, p = 0.022) and alcohol use (RR 0.77, p = 0.018) and a greater increase in fruit and vegetable intake (>= 5 servings/day) (RR 1.83, p = 0.008) and physical functioning score of the HRQoL scale (mean difference: 3.9 score, p = 0.016). The cost of delivering the peer-support intervention was US$22.5 per participant. There were no adverse events related to the intervention. We did not adjust for multiple comparisons, which may have increased the overall type I error rate.ConclusionsA low-cost community-based peer-support lifestyle intervention resulted in a nonsignificant reduction in diabetes incidence in this high-risk population at 24 months. However, there were significant improvements in some cardiovascular risk factors and physical functioning score of the HRQoL scale.