Determining the Effect of Education through the Mobile Program on blood sugar and Health Promoting lifestyle of women with pregnancy diabet
Design
Clinical trial with control and intervention group, with groups of parallel groups, without blinding, randomized, without phase phase on 76 patients. For randomization, a randomization list is used by a statistician.
Settings and conduct
The place is the health center and hospital of Baghmalek city. Before the intervention, intervention and control groups, in addition to informed consent, fasting blood sugar tests and oral glucose tolerance test are performed. Health and demographic health-promoting lifestyle questionnaire is completed. Lifestyle software is installed on the intervention group mobile phone. And the control group receive only routine care. The tests are taken again 4 weeks after the intervention and the lifestyle questionnaire is completed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Literacy for reading and writing -Pregnant women with prediabetes -Gestational age between 24 to 28 weeks-Having a smart phone-Willingness to participate in the study
Exclusion criteria: over diabetes - Use of lifestyle software - preeclampsia - hypertension - Reluctance to participate in the study
Intervention groups
Before the intervention, fasting blood sugar tests and oral glucose tolerance test are performed from the two intervention and control groups. The health-promoting lifestyle questionnaire is completed. The lifestyle software is installed on the intervention group's mobile phone and the control group only takes care of Receive routine. 4 weeks after the intervention, the tests are taken again and the questionnaire is completed.
Main outcome variables
Improving the right lifestyle; Improve blood sugar; Reduction of maternal and neonatal complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200817048434N1
Registration date:2020-11-04, 1399/08/14
Registration timing:registered_while_recruiting
Last update:2020-11-04, 1399/08/14
Update count:1
Registration date
2020-11-04, 1399/08/14
Registrant information
Name
Maryam Maleki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3323 9519
Email address
maleki.ma@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-21, 1399/06/31
Expected recruitment end date
2021-03-17, 1399/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Education through the Mobile Program on blood sugar and Health Promoting lifestyle of women with pregnancy diabet
Public title
Effect of Education through the Mobile Program on blood sugar and Health Promoting lifestyle of women with pregnancy diabet
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Literacy
pregnant women with pre-diabetes
gestational age between 24 and 28 weeks
having a smart phone
willingness to participate in the study
Exclusion criteria:
overt diabetes
use of lifestyle software
preeclampsia
hypertension
unwillingness to participate in the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning the type of intervention of the participants is random and random permutation blocks with block size 6 (using the table related to random permutations). A random list is prepared by a statistician. According to the randomized list, it is assigned by someone outside the study and according to the corresponding codes, to each person who enters the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Mobile application designed by Dr. Rokh Afrooz. Includes educational materials on six dimensions of a health-promoting lifestyle (diet and nutrition, physical activity and exercise, responsibility, interpersonal relationships, spiritual growth, stress management).
Intervention group: After randomization and informed consent, fasting blood sugar tests and oral glucose tolerance test are performed and a health-promoting lifestyle questionnaire is completed. Then, in addition to routine and routine care, Lifestyle software, which includes six dimensions of a health-promoting lifestyle, is installed on the intervention group's mobile phone and how to use it. It (including the use of educational materials, observance and attention to the correct principles of nutrition, exercise) is taught to pregnant mothers. 4 weeks after the test is taken again and the questionnaire is completed.
Category
Lifestyle
2
Description
Control group: After randomization and informed consent, fasting blood glucose and oral glucose tolerance tests are evaluated for the control group and a demographic questionnaire and a health-promoting lifestyle are completed. For people in the control group, only routine and normal care is considered. 4 weeks later, the tests are checked again and the health-promoting lifestyle questionnaire is completed. Finally, the results of the two groups are compared.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
City Clinic Number One
Full name of responsible person
Dr. Ali Davarpanah
Street address
Ayatollah Khamenei Street, next to Sepah Bank, Clinic No. 1 in the city
City
Baghmalek
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 4372 2497
Email
info@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad badvi
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6315733653
Phone
+98 61 3733 3838
Email
badvi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Maleki
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Gendarmerie plaza, Street next to Haj Heshmat Shahbazi University, The alley in front of the culture store
City
Nahavand
Province
Hamadan
Postal code
6591717851
Phone
+98 81 3323 9519
Email
Maleki.ma@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parvaneh Mousavi
Position
teacher
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ahvaz Jundishapur University of Medical Sciences
City
ahvaz
Province
Khouzestan
Postal code
6315733653
Phone
+98 61 3733 3838
Email
mousavi-p@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Maleki
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Gendarmerie plaza, Street next to Haj Heshmat Shahbazi University, The alley in front of the culture store
City
Nahvand
Province
Hamadan
Postal code
6591717851
Phone
0098 81 39519
Email
Maleki.ma@ajums.ac.ir
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