Protocol summary
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Study aim
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Determining the Effect of Education through the Mobile Program on blood sugar and Health Promoting lifestyle of women with pregnancy diabet
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Design
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Clinical trial with control and intervention group, with groups of parallel groups, without blinding, randomized, on 76 patients. For randomization, a randomization list is used by a statistician.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Improving the right lifestyle; Improve blood sugar; Reduction of maternal and neonatal complications
General information
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Reason for update
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The expected start and end dates are before the registration date of the clinical trial, and the journals have objections to publish the article.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200817048434N1
Registration date:
2020-11-04, 1399/08/14
Registration timing:
prospective
Last update:
2023-07-24, 1402/05/02
Update count:
1
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Registration date
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2020-11-04, 1399/08/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-12-21, 1399/10/01
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Expected recruitment end date
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2022-04-20, 1401/01/31
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Actual recruitment start date
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2020-12-21, 1399/10/01
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Actual recruitment end date
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2022-04-20, 1401/01/31
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Trial completion date
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2022-04-20, 1401/01/31
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Scientific title
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Effect of Education through the Mobile Program on blood sugar and Health Promoting lifestyle of women with pregnancy diabet
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Public title
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Effect of Education through the Mobile Program on blood sugar and Health Promoting lifestyle of women with pregnancy diabet
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
76
Actual sample size reached:
76
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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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).
Ethics committees
1
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Ethics committee
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Approval date
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2020-04-18, 1399/01/30
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Ethics committee reference number
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IR.AJUMS.REC.1399.076
Health conditions studied
1
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Description of health condition studied
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Gestational Diabetes
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ICD-10 code
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O24.41
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ICD-10 code description
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Gestational diabetes mellitus in pregnancy
Primary outcomes
1
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Description
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Gestational Diabetes
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Timepoint
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Before intervention, after intervention
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Method of measurement
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Blood sugar test, health-promoting lifestyle questionnaire
Intervention groups
1
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Description
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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.
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Category
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Lifestyle
2
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Description
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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.
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available