Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/05/2018
Date assigned
04/06/2018
Last edited
31/05/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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 August 2020

Who is funding the study?
King Abdulaziz City for Science and Technology (Saudi Arabia)

Who is the main contact?
Dr Rasmieh AlZeidan

Trial website

Contact information

Type

Public

Primary contact

Dr Rasmieh Alzeidan

ORCID ID

Contact details

PO Box 102599
Riyadh
11685
Saudi Arabia

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

31/08/2020

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

Sponsor information

Organisation

King Saud University

Sponsor details

PO Box 102599
Riyadh
11685
Saudi Arabia

Sponsor type

University/education

Website

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

31/08/2021

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes