Assessing the effect of education intervention program on improving self-management among women with gestational diabetes:Application of Health Belief Model
(1)Objectives: To determine the effect of educational intervention program on improving self-management among women with gestational diabetes: Application of Health Belief Model (2) Design: Interventional trial based on random allocation using randomized four blocks method in order to select two intervention and control groups. (3)Setting and conduct: This study is an interventional one which study population is women with gestational diabetes. Sample size considers 110 participants which will randomly select in two groups. (4)Participants including major eligibility criteria: Inclusion criteria: confirm gestational diabetes; tendency to study participation; history of at least one year of gestational diabetes. Exclusion criteria: unwillingness to study participation; not attendance in educational sessions. (5) Intervention: After determining the sample size, questionnaires will be completed by both intervention and control groups. Then, according to collected data, four educational sessions which will be lasted about 30 to 40 minutes using group discussion and question and answer accompany with educational package during one month. Then, in order to determine the effect of educational intervention program, questionnaires will be filled up after 3 and 6 months later. (6) Main outcome measures (variables):Self-management improvement.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072612460N10
Registration date:2016-09-19, 1395/06/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-19, 1395/06/29
Registrant information
Name
Roya Sadedgi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 327 5692
Email address
sadeghir@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Education vice chancellor of Tehran
Expected recruitment start date
2015-10-05, 1394/07/13
Expected recruitment end date
2016-02-05, 1394/11/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of education intervention program on improving self-management among women with gestational diabetes:Application of Health Belief Model
Public title
Assessing the effect of educational intervention program on improving self-management among women with gestational diabetes:Application of Health Belief Model
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: confirm gestational diabetes;tendency to study participation; history of at least one year of gestational diabetes.
exclusion criteria: unwillingness to study participation; not attendance in educational sessions.
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
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 committee of Tehran University of Medical Sciences
Street address
Poursina Ave.
City
Tehran
Postal code
Approval date
2015-08-04, 1394/05/13
Ethics committee reference number
IR.TUMS.REC.1394.982
Health conditions studied
1
Description of health condition studied
Type 2 diabete
ICD-10 code
024
ICD-10 code description
Diabetes Mellitus Arising In Pregnancy
Primary outcomes
1
Description
Self-management
Timepoint
Baseline and 3 and 6 month after intervention
Method of measurement
ُStandard Self-management Questionnaire
Secondary outcomes
1
Description
Health Beliefe Model constructs
Timepoint
Baseline and 3 and 6 months after intervention
Method of measurement
Researcher made Questionnaire
Intervention groups
1
Description
Intervention program will be conducted during one month including four educational sessions based on blended educational intervention program (Lecture,Group discussion,Question & Answer, Role playing,Educational film).
Each session's time is about 30-40 minutes.The meetings will try to discuss on diabetes,its complications,how to Self-management and diabetic diet.
Category
Prevention
2
Description
In the control group education will be in accordance with care centers usual process.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
South of Tehran health centers
Full name of responsible person
Dr.Javad Barzegr
Street address
No.4,Shafeei Alley,Quods Ave,Enghelab Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for education, Tehran University of Medical Sciences
Full name of responsible person
Dr.Mohammad Jalili
Street address
Central Building of Tehran University of Medical sciences,Quods St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for education, Tehran University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran university of Medical Sciences
Full name of responsible person
Dr.Masood Yonesiyan
Street address
Central Building of Tehran University of Medical sciences,Quods St.
City
Tehran
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, Tehran university of Medical Sciences
Proportion provided by this source
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
Tehran University of Medical Sciences
Full name of responsible person
Dr.Roya Sadeghi
Position
PhD/Academic staff
Other areas of specialty/work
Street address
Public Health Faculty, Tehran University of Medical Sciences ,Poorsina Ave.
City
Tehran
Postal code
141556446
Phone
+98 21 4293 3210
Fax
00
Email
sadeghir@tums.ac.ir
Web page address
00
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Roya Sadeghi
Position
phD
Other areas of specialty/work
Street address
Public Health Faculty,Tehran University of Medical Sciences , Poorsina Ave.
City
Tehran
Postal code
141556446
Phone
+98 21 4293 3210
Fax
00
Email
sadeghir@tums.ac.ir
Web page address
00
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Roya Sadeghi
Position
Academic staff/phD
Other areas of specialty/work
Street address
Public Health Faculty,Tehran University of Medical Sciences, Poorsina Ave.
City
Tehran
Postal code
141556446
Phone
+98 21 4293 3210
Fax
00
Email
sadeghir@tums.ac.ir
Web page address
00
Sharing plan
Deidentified Individual Participant Data Set (IPD)