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临床试验/NCT01795833
NCT01795833已完成不适用

A Pragmatic and Scaleable Strategy Using Mobile Technology to Promote Sustained Lifestyle Changes to Prevent Type 2 Diabetes in India and the UK

Imperial College London2 个研究点 分布在 1 个国家目标入组 2,062 人开始时间: 2013年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,062
试验地点
2
主要终点
Number of Participants With Progression to Type 2 Diabetes

研究概览

简要总结

Type 2 diabetes is a major healthcare problem in the developed and developing world. Recent clinical trials have demonstrated that it may be prevented by lifestyle intervention focused on diet and physical activity. These trials have been expensive and labour intensive and this has limited translation of the known benefits to the population at large.

We propose using a mobile phone intervention for lifestyle change and will assess it in a clinical trial(study) in people with impaired glucose regulation (high risk at developing type 2 diabetes).

The study will be conducted in both India and the UK. The purpose of the study is to assess the effectiveness and acceptability of a text messaging system to prevent the progression to diabetes in people with high risk. The study involves five visits to clinic over 2 year period.

Study participants will be divided into two groups by the computer generated random method - one is 'Usual Care' group and the other 'Text Messaging' group.

  • Usual care will consist of a 30 minute interview, delivering personalized diet and exercise advice, supplemented by written material and education regarding diabetes. This will be delivered once at the beginning of the study.
  • The intervention group will undergo the same initial interview and, in addition, will receive 3 times weekly text messaging with education, advice, support and motivation. These messages will be personalized to individual targets set at the initial interview.

The primary outcome will be progression to diabetes, with and without SMS intervention. Secondary outcomes will be improvements in physical activity (reported and directly measured), body weight and other cardiovascular risk factors (blood pressure, total and HDL cholesterol and serum triglycerides).

详细描述

Recruitment:

  • Target recruitment number will be 1834 in total (1134 for India and 700 for UK).
  • In India people at risk will be ascertained using the Indian Diabetes Risk Score followed by measurement of a single blood sample to assess glucose regulation (HbA1c) in those with high scores.
  • In the UK, high risk subjects will be ascertained from the National Health service (NHS) Health Check Scheme and from routine screening in primary care; UK recruitment will also be based on HbA1c.

Trial Design:

  1. Visit 1 (Screening)
  • Potential subjects will be invited to clinic for screening to determine their prediabetic state (defined as an HbA1c of 6.0-6.4%)and suitability to take part in the study.
  • Screening involves clinical measurements, physical measurements and laboratory measurements. Also, baseline questionnaires will be carried out at this visit.
  • ActiGraph, physical activity monitoring device will be fitted on that is to be kept for 7 days.
  1. Visit 2 (Education and Randomization)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults 18 yrs or over and less than 75 yrs
  • HbA1c between 6.0-6.4%

排除标准

  • Pregnant or planning pregnancy
  • Breastfeeding
  • Enrolled in other clinical trials
  • Have active malignancy or under investigation for malignancy
  • Are unable to follow the protocol for any other reason

结局指标

主要结局

Number of Participants With Progression to Type 2 Diabetes

时间窗: 24 months

The primary outcome will be progression to type 2 diabetes as measured by HbA1c at baseline, 6 months, 12 months and 24 months or by any validated criteria in any other care setting. the World health Organization (WHO) / International Diabetes Federation (IDF) criteria for diagnosis of diabetes will be used throughout.

次要结局

  • Body Weight(Baseline and 24 months)
  • Blood Pressure(Baseline and 24 months)
  • HDL Cholesterol(Baseline and 24 months)
  • LDL Cholesterol(Baseline and 24 months)
  • Triglycerides(Baseline and 24 months)
  • Total Physical Activity(Baseline and 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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