CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,062 enrolled
Drug / intervention
Short text messagesother
Likely dose
Not stated in record
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Search/NCT01795833
NCT01795833N/ACompleted

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 London·interventional·Posted Feb 21, 2013·Updated Oct 30, 2020

In Brief

A clinical study evaluating Short text messages for Prediabetes. Completed, enrolled 2,062 participants across 1 site.

Detailed Summary

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).

Study Details

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 21, 2013
Enrollment StartJun 3, 2013
Primary CompletionNov 30, 2017
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 13.4 years ago

Interventions

Short text messagesother

In addition to structured education on healthy lifestyle provided at baseline, subjects in the arm will receive short text messages containing educational, motivational and supportive content on diet, physical activity, and smoking (if appropriate) during the study period. The content will be appropriate to the stage of the transtheoretical model of behavioural change that the subject is in. This will be assessed by questionnaire at each visit to clinic.