RCT of SMS for Drivers With Pre-DM

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556880
• Other study ID #: HKCTR-560
• Status: Completed
• Phase: N/A
• First received: March 15, 2012
• Last updated: February 4, 2014
• Start date: May 2009
• Est. completion date: March 2012

Study information

• Verified date: February 2014
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: March 2012
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Glucose Intolerance
• Pre-diabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
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	Hong Kong Island

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Tung Wah Eastern Hospital

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence rate of DM	the incidence rate of DM during first year 12-month period	Follow-up in 12 months	No
Secondary	Body mass index		Baseline, follow-up in 12 months and 24 months	No
Secondary	Waist Circumference		Baseline, follow-up in 12 months and 24 months	No
Secondary	Fasting Glucose	Fasting plasma glucose and two-hour post-meal loading plasma glucose	Baseline, follow-up in 12 months and 24 months	No
Secondary	Blood pressure	Systolic blood pressure and diastolic blood pressure	Baseline, follow-up in 12 months and 24 months	No
Secondary	Lipid profile	Total cholesterol, triglycerides, high density lipoprotein cholesterol and low density lipoprotein cholesterol	Baseline, follow-up in 12 months and 24 months	No
Secondary	incidence of DM	incidence of DM for first two year 24-month period	Follow-up in 24 months	No