Objectives: This study aims to determine the effect of training package on self-care behavior and quality of life.
Design: Two parallel arm Randomized Controlled Trial.
Setting and conduct: This study will be conducted on 92 pregnant women with gestational diabetes referring to Tohid Hospital in Sanandaj. Eligible women will be selected convenience and will be randomly assigned into two groups with block sizes of 4 and 6 and allocation ratio of 1:1. A person from research team not involved in the recruitment and assigning participants will generate allocation sequence using a computerized program. Opaque sealed sequentially numbered envelops will be used for allocation concealment.
Participants: Pregnant women with gestational age of 24-28 weeks that suffering from gestational diabetes.
Interventions: Individuals in the intervention group will receive education about self-care behaviors regarding diabetes. Education plan includes four educational sessions as group discussion about 60 minutes; held for groups of 7 to 14 persons for four consecutive weeks. At the end of the first session, a booklet will be given to intervention group. The individuals in the control group will receive routine educations of prenatal care.
Main outcome measures include self-care behavior and quality of life that will be assessed by self-care behavior and quality of life (QOL-GRAV) questionnaires before and four weeks after the end of intervention. Secondary outcomes include pregnancy outcomes (gestational age at delivery, delivery type and anthropometric indices of newborn) that will be assessed by checklist after childbirth.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080510324N25
Registration date:2015-08-26, 1394/06/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-26, 1394/06/04
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2015-08-11, 1394/05/20
Expected recruitment end date
2015-11-11, 1394/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of training package on self-care behavior and quality of life in pregnant women with gestational diabetic
Public title
Effect of training package on self-care behavior and quality of life in pregnant women with gestational diabetic.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women with gestational diabetes under supervision in the diabetic clinic of Tohid Hospital in Sanandaj; Diagnosis of gestational diabetes by OGTT between 24-28 weeks of pregnancy; Singleton pregnancy ; Having at least secondary education; Self-care ability alone; Willingness to participate in the study; Possibility of going to hospital within 4 sequential weeks.
Exclusion criteria: Having other physical diseases (asthma and heart disease) and known psychiatric disease according to patient’s expression.
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, and East Azerbaijan Tabriz
City
Tabriz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
TBZMED.REC.1394.286
Health conditions studied
1
Description of health condition studied
Gestational diabetes
ICD-10 code
O24.4
ICD-10 code description
Diabetes mellitus arising in pregnancy
Primary outcomes
1
Description
Self-care behavior
Timepoint
Before and four weeks after the end of intervention
Method of measurement
Questionnaire
2
Description
Quality of life
Timepoint
Before and four weeks after the end of intervention
Method of measurement
Quality of life (QOL-GRAV) questionnaire
Secondary outcomes
1
Description
Gestational age at the delivery
Timepoint
After childbirth
Method of measurement
Checklist
2
Description
Delivery type
Timepoint
After childbirth
Method of measurement
Checklist
3
Description
Anthropometric indices of newborn
Timepoint
After childbirth
Method of measurement
Checklist
Intervention groups
1
Description
Interventional group: Individuals in the intervention group will receive education about self-care behaviors regarding diabetes. Education plan includes four educational sessions as group discussion about 60 minutes; held for groups of 7 to 14 persons for four consecutive weeks. At the end of the first session, a booklet will be given to intervention group. The content of the training manual contains definition of diabetes, causes, complications, treatment and prevention of disease complications with an emphasis on physical activity and appropriate nutrition.
Category
Lifestyle
2
Description
Control group: The individuals in the control group will receive routine educations of prenatal care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tohid Hospital
Full name of responsible person
Havin Zandi Nava
Street address
Tohid hospital, Geriashan street, Sanandaj city, Kurdistan province
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Havin Zandi Nava
Position
MSc student in Midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street Tabriz
City
Tabriz
Postal code
Phone
+98 87 3362 8972
Fax
Email
farnooshzandinava@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
347-51745
Phone
+98 41 1479 6770
Fax
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
347-51745
Phone
+98 41 1479 6770
Fax
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)