Clinical trial NCT01556880: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetes
Diabetes
Keywords: Drivers
Chinese
Short Message Service
Cellular Phone
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Tung Wah Eastern Hospital
First posted: 2012-03-16
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: incidence rate of DM
timeFrame: Follow-up in 12 months
Secondary outcomes:
measure: Body mass index
timeFrame: Baseline, follow-up in 12 months and 24 months
measure: Waist Circumference
timeFrame: Baseline, follow-up in 12 months and 24 months
measure: Fasting Glucose
timeFrame: Baseline, follow-up in 12 months and 24 months
measure: Blood pressure
timeFrame: Baseline, follow-up in 12 months and 24 months
measure: Lipid profile
timeFrame: Baseline, follow-up in 12 months and 24 months
measure: incidence of DM
timeFrame: Follow-up in 24 months
Other outcomes:
Locations:
city: Hong Kong Island
country: Hong Kong
facility: Department of Family Medicine and Primary Care, The University of Hong Kong
city: Hong Kong Island
country: Hong Kong
facility: Diabetes Centre, Department of Medicine and Rehabilitation, Tung Wah Eastern Hospital
city: Hong Kong Island
country: Hong Kong
facility: School of Nursing, The University of Hong Kong
Study officials:
affiliation: Department of Family Medicine and Primary Care, The University of Hong Kong
name: Cindy L.K. Lam, MD
role: STUDY_CHAIR
affiliation: Department of Family Medicine and Primary Care, The University of Hong Kong
name: Yvonne Y.C. Lo, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.