Diabetes Prevention Using SMS Technology
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Pragmatic and Scaleable Strategy Using Mobile Technology to Promote Sustained Lifestyle Changes to Prevent Type 2 Diabetes in India and the UK|
- Progression to type 2 diabetes [ Time Frame: at baseline, 6 months, 12 months and 24 months following randomisaton ] [ Designated as safety issue: No ]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.
- Change in physical measurements [ Time Frame: At baseline, 6 months, 12 months and 24 months following randomisation ] [ Designated as safety issue: No ]Change in physical measurements will be assessed by measuring weight, body mass index (BMI), waist circumference, hip circumference and waist: hip ratio at baseline, 6 months, 12 months and 24 months.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Text Messages
Short text messages related to healthy lifestyle will be sent to half the subjects three times per week, in addition to one off 'one-to-one structured education' during the study period.
Other: Short text messages
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.
No Intervention: Control
Half of the subjects who has received only one off 'one-to-one structured education about healthy lifestyle during the study period
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01795833
|Imperial college Healthcare NHS Trust|
|London, United Kingdom, W2 1NY|
|Principal Investigator:||Desmond G Johnston, PhD, MB ChB||Imperial College London|