RCT of SMS for Drivers With Pre-DM

Not Applicable

Completed

• Conditions: Diabetes; Pre-diabetes
• Interventions: Behavioral: Short Message Service (SMS)

• Registration Number: NCT01556880
• Lead Sponsor: The University of Hong Kong

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2010-05
• Study Completion: 2012-03
• Study First Submitted: 2012-03-15
• Study First Submitted QC: 2012-03-15
• Study First Posted: 2012-03-16
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-04
• Last Update Posted: 2014-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short Message Service (SMS)	Short Message Service (SMS)	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.

Primary Outcome Measures

Name	Time	Method
incidence rate of DM	Follow-up in 12 months	the incidence rate of DM during first year 12-month period

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Diabetes Centre, Department of Medicine and Rehabilitation, Tung Wah Eastern Hospital; 🇭🇰 Hong Kong Island, Hong Kong

School of Nursing, The University of Hong Kong; 🇭🇰 Hong Kong Island, Hong Kong

Department of Family Medicine and Primary Care, The University of Hong Kong; 🇭🇰 Hong Kong Island, Hong Kong