RCT of SMS for Drivers With Pre-DM

February 4, 2014 updated by: WONG King Ho Carlos, The University of Hong Kong

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong Island, Hong Kong
        • Department of Family Medicine and Primary Care, The University of Hong Kong
      • Hong Kong Island, Hong Kong
        • Diabetes Centre, Department of Medicine and Rehabilitation, Tung Wah Eastern Hospital
      • Hong Kong Island, Hong Kong
        • School of Nursing, The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Behavioral: 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.
NO_INTERVENTION: Standard usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence rate of DM
Time Frame: Follow-up in 12 months
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
Time Frame: Baseline, follow-up in 12 months and 24 months
Baseline, follow-up in 12 months and 24 months
Waist Circumference
Time Frame: Baseline, follow-up in 12 months and 24 months
Baseline, follow-up in 12 months and 24 months
Fasting Glucose
Time Frame: Baseline, follow-up in 12 months and 24 months
Fasting plasma glucose and two-hour post-meal loading plasma glucose
Baseline, follow-up in 12 months and 24 months
Blood pressure
Time Frame: Baseline, follow-up in 12 months and 24 months
Systolic blood pressure and diastolic blood pressure
Baseline, follow-up in 12 months and 24 months
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
Baseline, follow-up in 12 months and 24 months
incidence of DM
Time Frame: Follow-up in 24 months
incidence of DM for first two year 24-month period
Follow-up in 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Tung Wah Eastern Hospital

Investigators

  • Study Chair: Cindy L.K. Lam, MD, Department of Family Medicine and Primary Care, The University of Hong Kong
  • Principal Investigator: Yvonne Y.C. Lo, MBBS, Department of Family Medicine and Primary Care, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

March 15, 2012

First Submitted That Met QC Criteria

March 15, 2012

First Posted (ESTIMATE)

March 16, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 5, 2014

Last Update Submitted That Met QC Criteria

February 4, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKCTR-560

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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