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RCT of SMS for Drivers With Pre-DM

This study has been completed.
Sponsor:
Collaborator:
Tung Wah Eastern Hospital
Information provided by (Responsible Party):
WONG King Ho Carlos, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01556880
First received: March 15, 2012
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention
Pre-diabetes
Diabetes
 Behavioral: Short Message Service (SMS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Short Message Service by Cellular Phone for Professional Drivers With Pre-diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • incidence rate of DM [ Time Frame: Follow-up in 12 months ] [ Designated as safety issue: No ]
    the incidence rate of DM during first year 12-month period


Secondary Outcome Measures:
  • Body mass index [ Time Frame: Baseline, follow-up in 12 months and 24 months ] [ Designated as safety issue: No ]
  • Waist Circumference [ Time Frame: Baseline, follow-up in 12 months and 24 months ] [ Designated as safety issue: No ]
  • Fasting Glucose [ Time Frame: Baseline, follow-up in 12 months and 24 months ] [ Designated as safety issue: No ]
    Fasting plasma glucose and two-hour post-meal loading plasma glucose

  • Blood pressure [ Time Frame: Baseline, follow-up in 12 months and 24 months ] [ Designated as safety issue: No ]
    Systolic blood pressure and diastolic blood pressure

  • Lipid profile [ Time Frame: Baseline, follow-up in 12 months and 24 months ] [ Designated as safety issue: No ]
    Total cholesterol, triglycerides, high density lipoprotein cholesterol and low density lipoprotein cholesterol

  • incidence of DM [ Time Frame: Follow-up in 24 months ] [ Designated as safety issue: No ]
    incidence of DM for first two year 24-month period


Enrollment: 104
Study Start Date: May 2009
Study Completion Date: March 2012
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556880

Locations
Hong Kong
Diabetes Centre, Department of Medicine and Rehabilitation, Tung Wah Eastern Hospital
Hong Kong Island, Hong Kong
Department of Family Medicine and Primary Care, The University of Hong Kong
Hong Kong Island, Hong Kong
School of Nursing, The University of Hong Kong
Hong Kong Island, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
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
  More Information

No publications provided

Responsible Party: WONG King Ho Carlos, Post-doctoral Fellow, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01556880     History of Changes
Other Study ID Numbers: HKCTR-560
Study First Received: March 15, 2012
Last Updated: November 28, 2012
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
Drivers
Chinese
Short Message Service
Cellular Phone

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on May 23, 2013