This clinical trial was conducted to compare the effects of gain messages and loss messages sent through the short messaging service on eating behaviors among men with diabetes type 2, attended two educational medical centers in Isfahan, Iran. Method: 108 men with diabetes type 2 were selected through convenience sampling method and then divided into three case and control groups (36 men were allocated to each group through simple randomization). Simple randomization means that numbers 1-3 were assigned to the patients repeatedly and patients were assigned to one of the groups according to the (number 1 to the gain group; number 2 to the loss group; and number 3 to the control group). It was a single-blind study in which the patients were not aware of the group they were assigned. Inclusion criteria: Ability to read and write; ages over 30 years; ability to work with cell phones; and willingness of participating in the study. Exclusion criteria; suffering from diabetes less than 6 months; being illiterate; having no access to a cell phone; not residing in Isfahan; suffering from diagnosed mental disorders; suffering from severe visual and hearing impairments; and having advanced severe diseases in critical organs. The control group received routine care; and the case group was trained through the short messaging service for 3 months. The patients’ information was collected before and after intervention using a questionnaire. The outcomes in this study were Self-care feeding behaviors and side effects of unhealthy feeding behaviors.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012232104N1
Registration date:2017-06-21, 1396/03/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-21, 1396/03/31
Registrant information
Name
Fataneh Goodarzi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 910 605 1519
Email address
f.goodarzi@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Isfahan University of Medical Sciences.
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effects of Gain and Loss Messages Sent Through the Short Messaging Service on Eating Behaviors of Men with Diabetes Type 2.
Public title
Effects of Short Messages Sent by Cell Phone on Eating Behaviors.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria
Having medical records in the two educational medical centers; having cell phones personally or in the family; being able to read and write; being able to work with cell phones; being over 30 years old; suffering diabetes diagnosed at least 6 months earlier; suffering no diagnosed mental disorders if it was recorded in the patient’ medical records; having no advanced severe diseases in critical organs; such as kidneys and liver; and suffering no severe visual and hearing impairments.
Exclusion criteria: Having diabetes less than 6 months; being illiterate; having no access to a cell phone; not residing in Isfahan; suffering from diagnosed mental disorders; suffering from severe visual and hearing impairments; and having advanced severe diseases in critical organs;such as kidneys and liver.
Age
From 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 of Isfahan University of Medical Sciences.
Street address
Isfahan University of Medical Sciences, Hezarjarib Street, Isfahan
City
Isfahan
Postal code
8174673461
Approval date
2016-01-30, 1394/11/10
Ethics committee reference number
IR.mui.REC.1394.3.830
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
E10, E11,
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Self-care feeding behaviors
Timepoint
Before intervention and Immediately after the intervention.
Method of measurement
feeding behaviors Questionnaire.
Secondary outcomes
1
Description
Side effects of unhealthy feeding behaviors
Timepoint
Before intervention and Immediately after the intervention.
Method of measurement
feeding behaviors Questionnaire.
Intervention groups
1
Description
The gain case group: gain training messages were sent to patients in this case group twice a week; one message each time; for three months.
Category
Behavior
2
Description
The loss case group: loss training messages were sent to patients in this case group twice a week; one message each time; for three months.
Category
Behavior
3
Description
The Control case group: Control case group during three months receives of their routine education from diabetic clinic.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
T. S. Research Center
Full name of responsible person
Fataneh Goodarzi
Street address
Isfahan University of Medical Sciences, Hezarjarib Street, Isfahan
City
Isfahan
2
Recruitment center
Name of recruitment center
Al Zahra Hospital
Full name of responsible person
Fataneh Goodarzi
Street address
Isfahan University of Medical Sciences, Hezarjarib Street, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Isfahan University of Medical Sciences.
Full name of responsible person
Doctor Mahdi Nemat Bakhsh
Street address
Isfahan University of Medical Sciences, Hezarjarib Street, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Isfahan University of Medical Sciences.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fataneh Goodarzi
Position
Master Student in Health Education
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjarib Street, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 2752
Fax
+98 31 3668 2509
Email
fataneh.goodarzi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fereshteh Zamani-Alavijeh
Position
Associate Professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjarib Street, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 3292
Fax
+98 31 3668 2509
Email
fe.zamani@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fataneh Goodarzi
Position
M.SC Student of Health Education
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjarib Street, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 2752
Fax
+98 31 3668 2509
Email
fataneh.goodarzi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)