Plain English Summary
Background and study aims
Pre-diabetes is a condition where the person is not yet diabetic but is at a great risk to be so. A person with pre-diabetes has high blood sugar but not high enough to be called diabetic. A major way to stop a pre-diabetic from becoming diabetic is to have good amount of daily physical activity and eat a healthy diet. There are many ways to help people live a healthy lifestyle. The aim of this study is to see whether encouraging people through text messages helps them to eat healthily and move more.
Who can participate?
People above the age of 18 who are pre-diabetic
What does the study involve?
Participants are randomly allocated to one of two groups. One group is sent the text messages and the other group does not get any messages. Their blood sugar is measured to see which group benefited more. Both groups also get a standard education session on how to eat healthily and move more.
What are the possible benefits and risks of participating?
The expected side effect is a little pain from the needle when taking blood to test blood sugar.
Where is the study run from?
King Saud University Medical City (Saudi Arabia)
When is the study starting and how long is it expected to run for?
September 2018 to December 2020 (as of 19/10/2018)
Who is funding the study?
King Abdulaziz City for Science and Technology (Saudi Arabia)
Who is the main contact?
Dr Rasmieh AlZeidan
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
E-17-27607
Study information
Scientific title
The effectiveness of the text messages to modify lifestyle prevent or delay the onset of type 2 diabetes mellitus among university employees and their families with impaired glucose tolerance in Saudi Arabia: a randomized controlled trial
Acronym
Study hypothesis
The trialists hypothesize that the intervention group will have a significant bigger reduction in HA1C than the control group.
Ethics approval
IRB of King Saud University, College of Medicine, 03/10/2017, ref: E-17-27607
Study design
Prospective parallel-group randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Pre-diabetes
Intervention
A computer-generated randomization sequence (Matlab randperm version 6) based on Marsaglia's algorithm to randomly allocate patients (1:1) to individually tailored phone messaging or to a control group that received standard life modification advice at baseline visit only.
The intervention is lifestyle modification text messages that are tailored to the participant according to the Trans Theoretical Model (TTM) stage of change. Both control and intervention groups will receive a baseline standard lifestyle modification education session, and both groups take metformin tablets as prescribed by their treating physician.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Incident type 2 diabetes measured at the end of the study after 24 months
2. Hyperglycemia measured by HbA1c at baseline and 24 months
Secondary outcome measures
1. Level of low density lipoprotein cholesterol (LDL-C) at baseline and 24 months
2. Systolic diastolic blood pressure at baseline and 24 months
3. Body weight at baseline, 12 months and 24 months
4. Physical activity level checked at every 6 month follow up visit and at 24 months
5. Fruit/vegetables intake portions consumed per day at 24 months
6. Incidence of myocardial infarction, stroke, death and re-hospitalization checked through subjects' electronic file at the end of the study
Overall trial start date
01/09/2018
Overall trial end date
31/12/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. ≥ 18 years old
2. Speak and read Arabic or English as applicable
3. Use text messages on their mobile phones
4. Have prediabetes
5. HbA1c value between 5.7-6.4%
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
600
Participant exclusion criteria
1. < 18 years old
2. Pregnant women
3, Any subject who has overt diabetes
Recruitment start date
01/09/2018
Recruitment end date
30/09/2018
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
King Saud University Medical City
11472
Saudi Arabia
Funders
Funder type
Government
Funder name
King Abdulaziz City for Science and Technology
Alternative name(s)
KACST
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Saudi Arabia
Results and Publications
Publication and dissemination plan
Protocol and results to be published in a high impact peer reviewed journal.
IPD sharing statement
The access for data will be restricted to the minimal considering the patients' privacy and upon the approval of King Saud University IRB as it is not clear to what extent the trialists can share data from the legal point of view in Saudi Arabia.
Intention to publish date
31/12/2021
Participant level data
Other
Basic results (scientific)
Publication list
2019 protocol in https://www.ncbi.nlm.nih.gov/pubmed/31752774 (added 25/11/2019)