The role of text messages in helping people to change to a healthy lifestyle to stop them from getting diabetes type 2

ISRCTN	ISRCTN10857643
DOI	https://doi.org/10.1186/ISRCTN10857643
Protocol serial number	E-17-27607
Sponsor	King Saud University
Funder	King Abdulaziz City for Science and Technology

Submission date: 24/05/2018
Registration date: 04/06/2018
Last edited: 25/11/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Rasmieh Alzeidan
Public

PO Box 102599
Riyadh
11685
Saudi Arabia

Study information

Primary study design	Interventional
Study design	Prospective parallel-group randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	The trialists hypothesize that the intervention group will have a significant bigger reduction in HA1C than the control group.
Ethics approval(s)	IRB of King Saud University, College of Medicine, 03/10/2017, ref: E-17-27607
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	600
Key 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%
Key exclusion criteria	1. < 18 years old 2. Pregnant women 3, Any subject who has overt diabetes
Date of first enrolment	01/09/2018
Date of final enrolment	30/09/2018

Locations

Countries of recruitment

Saudi Arabia

Study participating centre

King Saud University Medical City

11472
Saudi Arabia

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
IPD sharing plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	21/11/2019	25/11/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/11/2019: Publication reference added.
19/10/2018: The following changes have been made to the trial record:
1. The overall trial end date has been changed from 31/08/2020 to 31/12/2020
2. The plain English summary has been updated to reflect the new trial end date
3. The intention to publish date has been changed from 31/08/2021 to 31/12/2021