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RCT of SMS for Drivers With Pre-DM

Primary Purpose

Pre-diabetes, Diabetes

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Short Message Service (SMS)
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-diabetes focused on measuring Drivers, Chinese, Short Message Service, Cellular Phone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Short Message Service (SMS)

Standard usual care

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 15, 2012
Last Updated
February 4, 2014
Sponsor
The University of Hong Kong
Collaborators
Tung Wah Eastern Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01556880
Brief Title
RCT of SMS for Drivers With Pre-DM
Official Title
A Randomized Controlled Trial of Short Message Service by Cellular Phone for Professional Drivers With Pre-diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Tung Wah Eastern Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes, Diabetes
Keywords
Drivers, Chinese, Short Message Service, Cellular Phone

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short Message Service (SMS)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard usual care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Short Message Service (SMS)
Intervention Description
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 Measure Information:
Title
incidence rate of DM
Description
the incidence rate of DM during first year 12-month period
Time Frame
Follow-up in 12 months
Secondary Outcome Measure Information:
Title
Body mass index
Time Frame
Baseline, follow-up in 12 months and 24 months
Title
Waist Circumference
Time Frame
Baseline, follow-up in 12 months and 24 months
Title
Fasting Glucose
Description
Fasting plasma glucose and two-hour post-meal loading plasma glucose
Time Frame
Baseline, follow-up in 12 months and 24 months
Title
Blood pressure
Description
Systolic blood pressure and diastolic blood pressure
Time Frame
Baseline, follow-up in 12 months and 24 months
Title
Lipid profile
Description
Total cholesterol, triglycerides, high density lipoprotein cholesterol and low density lipoprotein cholesterol
Time Frame
Baseline, follow-up in 12 months and 24 months
Title
incidence of DM
Description
incidence of DM for first two year 24-month period
Time Frame
Follow-up in 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cindy L.K. Lam, MD
Organizational Affiliation
Department of Family Medicine and Primary Care, The University of Hong Kong
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yvonne Y.C. Lo, MBBS
Organizational Affiliation
Department of Family Medicine and Primary Care, The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Family Medicine and Primary Care, The University of Hong Kong
City
Hong Kong Island
Country
Hong Kong
Facility Name
Diabetes Centre, Department of Medicine and Rehabilitation, Tung Wah Eastern Hospital
City
Hong Kong Island
Country
Hong Kong
Facility Name
School of Nursing, The University of Hong Kong
City
Hong Kong Island
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
24466598
Citation
Wong CK, Fung CS, Siu SC, Lo YY, Wong KW, Fong DY, Lam CL. A short message service (SMS) intervention to prevent diabetes in Chinese professional drivers with pre-diabetes: a pilot single-blinded randomized controlled trial. Diabetes Res Clin Pract. 2013 Dec;102(3):158-66. doi: 10.1016/j.diabres.2013.10.002.
Results Reference
result
PubMed Identifier
30309382
Citation
Wong CKH, Siu SC, Wong KW, Yu EYT, Lam CLK. Five-year effectiveness of short messaging service (SMS) for pre-diabetes. BMC Res Notes. 2018 Oct 10;11(1):709. doi: 10.1186/s13104-018-3810-y.
Results Reference
derived
PubMed Identifier
26798647
Citation
Wong CK, Jiao FF, Siu SC, Fung CS, Fong DY, Wong KW, Yu EY, Lo YY, Lam CL. Cost-Effectiveness of a Short Message Service Intervention to Prevent Type 2 Diabetes from Impaired Glucose Tolerance. J Diabetes Res. 2016;2016:1219581. doi: 10.1155/2016/1219581. Epub 2015 Dec 21.
Results Reference
derived

Learn more about this trial

RCT of SMS for Drivers With Pre-DM

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