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尼泊尔预防糖尿病的工作场所干预研究:一项随机试验方案。

Worksite intervention study to prevent diabetes in Nepal: a randomised trial protocol.

作者信息

Pyakurel Prajjwal, Shrestha Archana, Karmacharya Biraj M, Budhathoki Shyam S, Chaudhari Rajendra Kumar, Tamrakar Dipesh, Shrestha Abha, Karmacharya Robin M, Shrestha Anmol, Sharma Sumitra, Sharma Sanjib Kumar, Spiegelman Donna

机构信息

B.P. Koirala Institute of Health Sciences, Dharan, Nepal

Kathmandu University School of Medical Sciences, Kathmandu, Nepal.

出版信息

Open Heart. 2020 Aug;7(2). doi: 10.1136/openhrt-2019-001236.

Abstract

INTRODUCTION

In Nepal, approximately 31% of adult industrial employees have diabetes. While the prevention of type 2 diabetes through behavioural intervention has been disseminated, worksite could be an effective platform for the translation of this knowledge into action as employed adults spend most of their workday waking hours at workplaces.

METHODS AND ANALYSIS

We will conduct a randomised controlled trial to assess the effectiveness of a behavioural and a canteen intervention on diabetes risk reduction among those who are prediabetic at two worksites in eastern Nepal. We will recruit 162 adult full-time factory workers with haemoglobin A1c (HbA1c) of 5.7%-6.4% at baseline or fasting blood sugar of 100-125 mg/dL. The 8-14 months' control period will be followed by the behavioural intervention where half of the participants will be randomised to receive the behavioural intervention and half will act as a control and will not receive any intervention. Then, all participants will receive the canteen intervention. The analysis will be intent-to-treat, comparing the difference in the change in HbA1c% between the behavioural intervention group and the control group using a two-sample t-test. The within-participant changes in HbA1c after 6 or more months on the canteen intervention among those not randomised to the behavioural intervention in the previous period will be assessed using the paired t-test.

ETHICS AND DISSEMINATION

Ethical approval was obtained from the Institutional Review Board at Yale School of Public Health, New Havens, USA and the Nepal Health Research Council.

TRIAL REGISTRATION NUMBER

NCT04161937.

摘要

引言

在尼泊尔,约31%的成年产业工人患有糖尿病。虽然通过行为干预预防2型糖尿病的方法已得到推广,但工作场所可能是将这一知识转化为行动的有效平台,因为成年就业人员大部分工作日清醒时间都在工作场所度过。

方法与分析

我们将进行一项随机对照试验,以评估行为干预和食堂干预对尼泊尔东部两个工作场所的糖尿病前期患者降低糖尿病风险的有效性。我们将招募162名成年全职工厂工人,他们在基线时糖化血红蛋白(HbA1c)为5.7%-6.4%或空腹血糖为100-125毫克/分升。在为期8-14个月的对照期之后进行行为干预,届时一半参与者将被随机分配接受行为干预,另一半作为对照组,不接受任何干预。然后,所有参与者都将接受食堂干预。分析将采用意向性分析,使用双样本t检验比较行为干预组和对照组之间HbA1c%变化的差异。对于前一阶段未被随机分配接受行为干预的参与者,将使用配对t检验评估在食堂干预6个月或更长时间后HbA1c的个体内变化。

伦理与传播

已获得美国纽黑文耶鲁大学公共卫生学院机构审查委员会和尼泊尔卫生研究委员会的伦理批准。

试验注册号

NCT04161937。

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