The Effects of an educational intervention based on the theory of planned behavior on self-care behavior and blood glucose levels in pregnant women with gestational diabetes treated with insulin
This randomized clinical trial study was done with the aim of determining the effect of an educational intervention based on the theory of planned behavior on self-care behavior and blood glucose levels in pregnant women with gestational diabetes treated with insulin. The main inclusion criteria was women with gestational diabetes treated with insulin with gestational age of 30-24 week, without having physical and mental illnesses Which were referred to Hospital Diabetes Clinic Ommolbanin Mashhad in 1393. They were randomly divided into two groups of 30 individuals (60 individuals). In intervention group, education based on the theory of planned behavior was performed with 4 sessions of 60 minutes and in the control group received no intervention. Data collection instruments was demographic questionnaire, knowledge and questionnaire theory of planned behavior questions and self-care behavior, perceived stress questionnaire.The blood sugar tests was including fasting blood sugar and Blood sugar two hours after a meal. Completed questionnaires before and four weeks after the completion of the intervention and Blood glucose tests were performed. In the end, based on the results was evaluated Impact theory-based intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014080418682N1
Registration date:2015-03-13, 1393/12/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-13, 1393/12/22
Registrant information
Name
maryam hoseinzadeh
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 4254 0384
Email address
hoseinzadehm911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2014-10-31, 1393/08/09
Expected recruitment end date
2015-02-19, 1393/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of an educational intervention based on the theory of planned behavior on self-care behavior and blood glucose levels in pregnant women with gestational diabetes treated with insulin
Public title
The Effects of an educational intervention based on the theory of planned behavior on self-care and blood glucose levels in pregnant women with gestational diabetes treated with insulin
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: (1) Written informed consent have for participation in the study (2) Maternal gestational age 20-24 weeks at the time of study entrance based on The first day of the last menstrual or the first half of pregnancy ultrasoundS (3) Iranian and resident of Mashhad (4) At least fifth grade literacy (5) Pregnant women with diagnosis of gestational diabetes are treated with human insulin (not analog) (6) Being able to communicate verbally.(7).No alcohol, smoking and drugs (8) dose not medical history of the medical disease (9).dose not referral to the psychiatrist or psychologist During the year prior and medication and hospitalization due to mental illness (10) dose not a high risk pregnancy (11) dose not to the cause underlying disease taking Continuously Glucocorticoid therapy (12) have The phone number for contact. Exclusion criteria during the study: (1) lack of willingness to continue participation in study (2) major stressful events during the study (3) the absence in any training sessions (4) The occurrence of pregnancy-related complications.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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
The ethics committeeat the University ofMedical SciencesMashhad
Street address
University Avenue-University of Medical Sciences headquarters
City
mashhad
Postal code
Approval date
2014-10-29, 1393/08/07
Ethics committee reference number
research/930418/1/199
2
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Crossroads Doctora- Mashhad -school of Nursing and Midwifery
City
mashhad
Postal code
Approval date
2014-10-29, 1393/08/07
Ethics committee reference number
research/930418/1/199
Health conditions studied
1
Description of health condition studied
gestational diabetes
ICD-10 code
024.4
ICD-10 code description
Diabetes mellitus arising in pregnancy
Primary outcomes
1
Description
self Care Behavior
Timepoint
Baseline (pre-intervention) and one month after intervention
Method of measurement
questionnaire
2
Description
self care Behavior
Timepoint
Baseline (pre-intervention) and one month after intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
blood glucose tests was including fasting blood glucose and Blood glucose two hours after a meal
Timepoint
before and four weeks after the completion of the intervention
Method of measurement
Blood tests
2
Description
Level Blood glucose
Timepoint
Baseline (pre-intervention) and one month after intervention
Method of measurement
Blood tests
Intervention groups
1
Description
patients in the control group received routine prenatal visits by Diabetologist and obstetrician or midwife and only education based on the theory of planned behavior did not receive So that was mentioned in the intervention group.
Category
Behavior
2
Description
In intervention group, education based on the theory of planned behavior was performed with 4 sessions of 60 minutes
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ommolbanin hospital diabetes clinic
Full name of responsible person
maryam hoseinzadeh
Street address
City
mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen tafaghodi
Street address
mashhad- University avenue-University of Medical Sciencesheadquarters
City
mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Hoseinzadeh
Position
post graduate student midwifery
Other areas of specialty/work
Street address
Mashhad, University Avenue, Crossroads doctora, Ibn Sina Avenue, School of Nursing and Midwifery
City
mashhad
Postal code
Phone
+98 13 4254 0384
Fax
Email
HoseinzadehM911@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
talat Khadivzadeh
Position
PhD in Reproductive Health - Member of Scientific Advisory Board
Other areas of specialty/work
Street address
Mashhad, University Avenue, Crossroads doctora, Avenue Ibn Sina, Faculty of Nursing and Midwifery
City
mashhad
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
Khadivzadeht@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
maryam hoseinzadeh
Position
Postgraduate Student Midwifery
Other areas of specialty/work
Street address
Mashhad, University Avenue, Crossroads doctora, Ibn Sina Avenue, School of Nursing and Midwifery
City
mashhad
Postal code
Phone
Fax
Email
HoseinzadehM911@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)