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Completed

NCT Number: NCT01556880

RCT of SMS for Drivers With Pre-DM

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Short Message Service (SMS)

Behavioral

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 outcomes

  1. incidence rate of DM

    Time frame: Follow-up in 12 months

    the incidence rate of DM during first year 12-month period

Secondary outcomes

  1. Body mass index

    Time frame: Baseline, follow-up in 12 months and 24 months

  2. Waist Circumference

    Time frame: Baseline, follow-up in 12 months and 24 months

  3. Fasting Glucose

    Time frame: Baseline, follow-up in 12 months and 24 months

    Fasting plasma glucose and two-hour post-meal loading plasma glucose

  4. Blood pressure

    Time frame: Baseline, follow-up in 12 months and 24 months

    Systolic blood pressure and diastolic blood pressure

  5. Lipid profile

    Time frame: Baseline, follow-up in 12 months and 24 months

    Total cholesterol, triglycerides, high density lipoprotein cholesterol and low density lipoprotein cholesterol

  6. incidence of DM

    Time frame: Follow-up in 24 months

    incidence of DM for first two year 24-month period

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Tung Wah Eastern Hospital

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Mar 16, 2012
Registry last updated
Feb 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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