RCT of SMS for Drivers With Pre-DM

Study Overview
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Brief Summary
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The purpose of this study is to prevent the professional drivers from pre-diabetes to diabetes.

Detailed Description
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Mobile phone use is almost a routine part of society worldwide. All mobile phones can deliver and receive short-messaging service text messages, providing a perfect medium for delivering information and support. Since short-messaging service is little exploited in clinical research or practice in Chinese population, this study examined the effectiveness of one-way messaging which is less expensive and is easier to undertake. We aimed to determine the effectiveness of using SMS to provide pre-diabetes and diabetes information by promoting healthy lifestyle modification and reducing the two-hour post-glucose loading plasma glucose, the risk of acquiring Type 2 Diabetes Mellitus among professional drivers with pre-diabetes.

Official Title
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A Randomized Controlled Trial of Short Message Service by Cellular Phone for Professional Drivers With Pre-diabetes

Conditions
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Pre-diabetes, Diabetes

Intervention / Treatment
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* Behavioral: Short Message Service (SMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: identified within the last 3 months with pre-diabetes which is defined as a fasting plasma glucose level of 5.6-6.9 mmol/L or a two-hour level after a 75 grams glucose load of 7.8-11 mmol/L based on the World Health Organization 1998 criteria; accessible by mobile phone that could receive Chinese text messages. Exclusion Criteria: a history of diabetes mellitus; currently on medicines known to alter glucose tolerance; did not have a mobile phone; unable to read Chinese characters; refused to take part in current study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short Message Service (SMS)<br>A computer-based text message database was created. Messages prompted subjects to get rid of smoking and eating out, to persevere with the quit smoking attempt with the emphasis on the peer pressure on the smoking cessation by the smoking ban in restaurants. They encouraged them to overcome the barriers of healthy eating diet and physical activity with a block of text messages. | Behavioral: Short Message Service (SMS)<br>* A computer-based text message database was created. Messages prompted subjects to get rid of smoking and eating out, to persevere with the quit smoking attempt with the emphasis on the peer pressure on the smoking cessation by the smoking ban in restaurants. They encouraged them to overcome the barriers of healthy eating diet and physical activity with a block of text messages.<br>|
| No Intervention: Standard usual care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence rate of DM | the incidence rate of DM during first year 12-month period | Follow-up in 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index |  | Baseline, follow-up in 12 months and 24 months | 
| Waist Circumference |  | Baseline, follow-up in 12 months and 24 months | 
| Fasting Glucose | Fasting plasma glucose and two-hour post-meal loading plasma glucose | Baseline, follow-up in 12 months and 24 months | 
| Blood pressure | Systolic blood pressure and diastolic blood pressure | Baseline, follow-up in 12 months and 24 months | 
| Lipid profile | Total cholesterol, triglycerides, high density lipoprotein cholesterol and low density lipoprotein cholesterol | Baseline, follow-up in 12 months and 24 months | 
| incidence of DM | incidence of DM for first two year 24-month period | Follow-up in 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drivers, Chinese, Short Message Service, Cellular Phone