Protocol summary

Study aim
Comparing the effect of text messaging and Telegram Reminder on Adherence to the Drug and Food Regimen of Teens with Diabetes
Design
In this study, 75 adolescents aged 12-16 years with diabetes who were randomly selected to enter the study were selected and divided into three groups of two groups of intervention and one control group and each participant was assigned a code.
Settings and conduct
the patients were divided into three groups of 25, control, SMS and telegram groups. All three groups of Mediterranean diet and drug compliance questionnaires were assigned 8 items of MMAS-8. Then, the questionnaires were completed by the control group, SMS and telegram during the intervention at the end of the 4th, 8th and 12th week.
Participants/Inclusion and exclusion criteria
Sample acceptance criteria: 1. Have reading and writing skills 2. Having a mobile phone 3. Familiarity with SMS and Telegram 4. Use SMS service 5. Ability to read SMS by patient or companion 6. Parental Satisfaction in the Student Company of the Students 7. Without chronic mental illness. 8-Three to eight months have passed from their medical diagnosis and they have not had a severe complication. Sampling criteria: 1-Unwilling to continue participating in the study 2. Failure to understand and answer questions 3. There is a specific disease other than diabetes. 4. Subjects have not participated in courses.
Intervention groups
In the intervention group, there is no intervention in the control group regarding the diet, physical activity and exercise, glucose control with glucometer, drug use, and response to questions and resolution of the ambiguities for adolescents with diabetes.
Main outcome variables
Adherence to the diet and diet of adolescents with type 1 diabetes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170512033932N4
Registration date: 2018-08-21, 1397/05/30
Registration timing: retrospective

Last update: 2018-08-21, 1397/05/30
Update count: 0
Registration date
2018-08-21, 1397/05/30
Registrant information
Name
Hosein Motahariniya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3222 4908
Email address
h_hojjati@aliabadiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-06-10, 1397/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of text messaging and Telegram Reminder on Adherence to the Drug and Food Regimen of Teens with Diabetes
Public title
Comparing the effect of text messaging and Telegram Reminder on Adherence to the Drug and Food Regimen of Teens with Diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have reading and writing skills Having a cell phone Introduction to SMS and Telegram Ability to read SMS by the patient or accompanying him Parental satisfaction at the company of their children in the study No chronic mental illness Three months have passed since their medical diagnosis and they have no complications.
Exclusion criteria:
Unwillingness to continue participating in the study Failure to understand and answer questions There is a specific disease other than diabetes. Subjects did not attend training courses.
Age
From 12 years old to 16 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
The random sampling method was randomly assigned to those who entered the study and randomly divided into randomized, randomized, randomized random-assignment (Random allocation rule) to control and control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee for Biological Researches at the Azad University of shahrood
Street address
Azad University Ave,Shahrood Azad University
City
shahrood
Province
Semnan
Postal code
43189-36199
Approval date
2018-04-28, 1397/02/08
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1397.1

Health conditions studied

1

Description of health condition studied
The diet of diabetic patients
ICD-10 code
E10.7
ICD-10 code description
The diet of diabetic patients

Primary outcomes

1

Description
MMAS-8 drug compliance questionnaire
Timepoint
Before the intervention begins and after intervention
Method of measurement
Based on the total score of drug compliance

2

Description
Mediterranean dietary scorecard score
Timepoint
Before the intervention begins and after intervention
Method of measurement
Based on the total score of the Mediterranean diet

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the SMS group of Persian SMS, and in the telegram group, along with educational messages with the help of photographs, educational films are also sent. The contents of the educational program are the implications of the Mediterranean diet, physical activity and exercise, glucose control with glucometers, and drug use.
Category
Behavior

2

Description
Control group: Without special training
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Children's Hospital in Gorgan
Full name of responsible person
Dr. Hamid Haghshenas
Street address
Janbazan Ave., Children's Hospital Taleghani
City
Gorgan
Province
Golestan
Postal code
49166 68197
Phone
+98 17 3223 4364
Email
hoseinmotahari@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ruholah Samiee
Street address
Azad univercity Blvd,azad univercity
City
Aliabad katun
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 4500
Email
h_hojjati1362@yahoo.com
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahla Tajari
Position
Masters student of children
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Azad university, Azad blvd.
City
Ali abad katul
Province
Golestan
Postal code
4916845118
Phone
+98 17 3212 8035
Email
hoseinmotathari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahla Tajari
Position
Nursing Graduate Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Azad ave, Azad univercity
City
Aliabad katul
Province
Golestan
Postal code
4941793451
Phone
+98 911 177 2258
Email
hoseinmotahari@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamaid Hojjati
Position
Associate Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Azad blvd.
City
Aliabad katul
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 4500
Email
h_hojjati1392@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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