Pre-diabetesNCT01556880
RCT of SMS for Drivers With Pre-DM
A study testing Short Message Service (SMS) in people with Pre-diabetes and Diabetes, run by The University of Hong Kong at 3 sites in Hong Kong.
Trial summary
The purpose of this study is to prevent the professional drivers from pre-diabetes to diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre-diabetes, Diabetes
- What is being tested?
- Short Message Service (SMS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 3 sitesHong Kong
- Study dates
- May 2009to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
Department of Family Medicine and Primary Care, The University of Hong Kong
Hong Kong Island
Diabetes Centre, Department of Medicine and Rehabilitation, Tung Wah Eastern Hospital
Hong Kong Island
School of Nursing, The University of Hong Kong
Hong Kong Island
About this study
Official title: A Randomized Controlled Trial of Short Message Service by Cellular Phone for Professional Drivers With Pre-diabetes
The purpose of this study is to prevent the professional drivers from pre-diabetes to diabetes.
Read the 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.
- Conditions
- Pre-diabetes, Diabetes
- Being tested
- Short Message Service (SMS)
- Keywords
- Drivers, Chinese, Short Message Service, Cellular Phone
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Message Service (SMS)Behavioural
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 group | Role | What they receive |
|---|---|---|
| Short Message Service (SMS) | Experimental | 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. Receives: Behavioral: Short Message Service (SMS) |
| Standard usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence rate of DM
the incidence rate of DM during first year 12-month period
Measured: Follow-up in 12 months
Secondary outcomes (6)
Body mass index
Measured: Baseline, follow-up in 12 months and 24 months
Waist Circumference
Measured: Baseline, follow-up in 12 months and 24 months
Fasting Glucose
Fasting plasma glucose and two-hour post-meal loading plasma glucose
Measured: Baseline, follow-up in 12 months and 24 months
Blood pressure
Systolic blood pressure and diastolic blood pressure
Measured: Baseline, follow-up in 12 months and 24 months
Lipid profile
Total cholesterol, triglycerides, high density lipoprotein cholesterol and low density lipoprotein cholesterol
Measured: Baseline, follow-up in 12 months and 24 months
incidence of DM
incidence of DM for first two year 24-month period
Measured: Follow-up in 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startMay 2009
- Primary completionMay 2010
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Tung Wah Eastern Hospital
- Responsible party
- Principal investigator, WONG King Ho Carlos, The University of Hong Kong
- Investigators
- Cindy L.K. Lam, MD, Study chair, Department of Family Medicine and Primary Care, The University of Hong KongYvonne Y.C. Lo, MBBS, Principal investigator, Department of Family Medicine and Primary Care, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556880
- Sponsor's protocol ID
- HKCTR-560
- Status last verified
- Feb 2014
- First submitted
- 15 Mar 2012
- Last updated
- 5 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24466598Wong 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.
PubMed 30309382Wong 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.
PubMed 26798647
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Short Message Service by Cellular Phone for Professional Drivers With Pre-diabetes
- ClinicalTrials.gov ID
- NCT01556880
- Acronym / sponsor ID
- HKCTR-560
- Conditions
- Pre-diabetes, Diabetes
- Keywords
- Drivers, Chinese, Short Message Service, Cellular Phone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Tung Wah Eastern Hospital
- Study start
- May 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 16 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short Message Service (SMS) | Experimental | 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. |
| Standard usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Short Message Service (SMS) |
Primary outcome
incidence rate of DM
Time frame: Follow-up in 12 months
the incidence rate of DM during first year 12-month period
6 secondary outcomes
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
Blood pressure
Time frame: Baseline, follow-up in 12 months and 24 months
Lipid profile
Time frame: Baseline, follow-up in 12 months and 24 months
incidence of DM
Time frame: Follow-up in 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2014.
- Results publication: PubMed 24466598Wong 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.
- Derived from this study: PubMed 30309382Wong 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.
- Derived from this study: PubMed 26798647Wong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy L.K. Lam, MD study chair
Department of Family Medicine and Primary Care, The University of Hong Kong
Yvonne Y.C. Lo, MBBS principal investigator
Department of Family Medicine and Primary Care, The University of Hong Kong
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Message Service (SMS) in people with Pre-diabetes and Diabetes, run by The University of Hong Kong at 3 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence rate of DM (time frame: Follow-up in 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01556880, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2014.