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Trial record 89 of 666 for:    SMS

RCT of SMS for Drivers With Pre-DM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01556880
Recruitment Status : Completed
First Posted : March 16, 2012
Last Update Posted : February 5, 2014
Sponsor:
Collaborator:
Tung Wah Eastern Hospital
Information provided by (Responsible Party):
WONG King Ho Carlos, The University of Hong Kong

Tracking Information
First Submitted Date  ICMJE March 15, 2012
First Posted Date  ICMJE March 16, 2012
Last Update Posted Date February 5, 2014
Study Start Date  ICMJE May 2009
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
incidence rate of DM [ Time Frame: Follow-up in 12 months ]
the incidence rate of DM during first year 12-month period
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01556880 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
  • Body mass index [ Time Frame: Baseline, follow-up in 12 months and 24 months ]
  • Waist Circumference [ Time Frame: 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
  • Blood pressure [ Time Frame: Baseline, follow-up in 12 months and 24 months ]
    Systolic blood pressure and diastolic blood pressure
  • 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
  • incidence of DM [ Time Frame: Follow-up in 24 months ]
    incidence of DM for first two year 24-month period
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RCT of SMS for Drivers With Pre-DM
Official Title  ICMJE A Randomized Controlled Trial of Short Message Service by Cellular Phone for Professional Drivers With Pre-diabetes
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Condition  ICMJE
  • Pre-diabetes
  • Diabetes
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Short Message Service (SMS)
  • No Intervention: Standard usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2012)
104
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01556880
Other Study ID Numbers  ICMJE HKCTR-560
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party WONG King Ho Carlos, The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE Tung Wah Eastern Hospital
Investigators  ICMJE
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
PRS Account The University of Hong Kong
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP