iHealth-T2D 研究：一项针对中心性肥胖和糖尿病前期南亚人群的 2 型糖尿病预防的聚类随机试验——统计分析计划。

The iHealth-T2D study: a cluster randomised trial for the prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes-a statistical analysis plan.

机构信息

Department of Public Health, Amsterdam UMC, University of Amsterdam, Amsterdam Public Health Research Institute, Meibergdreef 9, Amsterdam, The Netherlands.

Amsterdam Public Health, Health Behaviours & Cardiovascular Diseases, Amsterdam Cardiovascular Sciences, Diabetes & Metabolism, Amsterdam, The Netherlands.

出版信息

Trials. 2022 Sep 6;23(1):755. doi: 10.1186/s13063-022-06667-1.

DOI:10.1186/s13063-022-06667-1

PMID:36068618

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9450360/

Abstract

BACKGROUND

South Asians are at high risk of type 2 diabetes (T2D). Lifestyle modification is effective at preventing T2D amongst South Asians, but the approaches to screening and intervention are limited by high costs, poor scalability and thus low impact on T2D burden. An intensive family-based lifestyle modification programme for the prevention of T2D was developed. The aim of the iHealth-T2D trial is to compare the effectiveness of this programme with usual care.

METHODS

The iHealth-T2D trial is designed as a cluster randomised controlled trial (RCT) conducted at 120 sites across India, Pakistan, Sri Lanka and the UK. A total of 3682 South Asian men and women with age between 40 and 70 years without T2D but at elevated risk for T2D [defined by central obesity (waist circumference ≥ 95 cm in Sri Lanka or ≥ 100 cm in India, Pakistan and the UK) and/or prediabetes (HbA1c ≥ 6.0%)] were included in the trial. Here, we describe in detail the statistical analysis plan (SAP), which was finalised before outcomes were available to the investigators. The primary outcome will be evaluated after 3 years of follow-up after enrolment to the study and is defined as T2D incidence in the intervention arm compared to usual care. Secondary outcomes are evaluated both after 1 and 3 years of follow-up and include biochemical measurements, anthropometric measurements, behavioural components and treatment compliance.

DISCUSSION

The iHealth-T2D trial will provide evidence of whether an intensive family-based lifestyle modification programme for South Asians who are at high risk for T2D is effective in the prevention of T2D. The data from the trial will be analysed according to this pre-specified SAP.

ETHICS AND DISSEMINATION

The trial was approved by the international review board of each participating study site. Study findings will be disseminated through peer-reviewed publications and in conference presentations.

TRIAL REGISTRATION

EudraCT 2016-001,350-18 . Registered on 14 April 2016.

CLINICALTRIALS

gov NCT02949739 . Registered on 31 October 2016.

摘要

背景

南亚人患 2 型糖尿病（T2D）的风险很高。生活方式的改变对于预防南亚人患 T2D 是有效的，但由于成本高、可扩展性差，因此对 T2D 负担的影响较低，筛查和干预方法受到限制。我们开发了一种针对预防 T2D 的强化家庭为基础的生活方式改变方案。iHealth-T2D 试验的目的是比较该方案与常规护理的效果。

方法

iHealth-T2D 试验设计为在印度、巴基斯坦、斯里兰卡和英国的 120 个地点进行的群组随机对照试验（RCT）。共有 3682 名年龄在 40 至 70 岁之间、没有 T2D 但 T2D 风险较高（定义为中心性肥胖（斯里兰卡腰围≥95cm，印度、巴基斯坦和英国腰围≥100cm）和/或糖尿病前期（HbA1c≥6.0%））的南亚男女参加了这项试验。在这里，我们详细描述了统计分析计划（SAP），该计划是在研究结果可供研究者使用之前确定的。主要结果将在纳入研究后 3 年的随访后进行评估，并定义为干预组与常规护理相比的 T2D 发病率。次要结果将在 1 年和 3 年的随访后进行评估，包括生化测量、人体测量测量、行为成分和治疗依从性。