The aim of this study was to determine the effects of cognitive behavioral counseling on lifestyle and self-efficacy in women with gestational diabetes. This study is a double blind randomized trial. Participants included 60 women with gestational diabetes who referred to diabetes clinic in Sanandaj city and elected by available the sampling method. Inclusion criteria were: age of pregnancy between 20 to 30 weeks; have negative attitude towards gestational diabetes; no mental illness and no taking psychiatric drugs. Using simple random sampling of participants in the intervention and control groups (each group 30 persons) will be allocated. After random distribution, the measures including lifestyle and self efficacy in both groups by Walkers promoting healthy lifestyle questionnaire and diabetes self-efficacy questionnaire carried out. For the intervention group Consultation in the form of groups of 10 people with cognitive behavioral approach during seven sessions of one and half hours every week in one of the health centers in Sanandaj, which is a suitable condition, will be executed. For the control group in addition to routine clinic care, after completing the assessments, a training plan will be held. After the intervention, and a month later measures will be repeated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011631977N1
Registration date:2017-01-26, 1395/11/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-26, 1395/11/07
Registrant information
Name
Aazam Bakhteh
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
کرمانشاه
Email address
aa_bakhteh@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-01-14, 1395/10/25
Expected recruitment end date
2017-04-20, 1396/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cognitive Behavioral Counseling On Lifestyle and Self-efficacy in WomenWith Gestational Diabetes
Public title
Effect of Cognitive Behavioral Counseling on Lifestyle and Self-efficacy in Women With Gestational Diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with gestational diabetes at 20 -30 weeks of gestational age; has a negative attitude towards gestational diabetes; no history of infertility; least literate; fluent in Persian; no participate in class relaxation, yoga, exercise during pregnancy; no underlying physical illness or complication of pregnancy; no history of diabetes before pregnancy; no addiction; no mental illness; no history of mental, nerves and hypnotic drug use and No known diseases of the fetus.
Exclusion criteria: lack of desire to continue to participate in the study; occure maternal or fetal complications during the study (abortion, fetal death, etc); occurrence any mental illness need medication during the intervention; Attending prenatal classes; no participate in more than two sessions of counseling sessions.
Age
From 18 years old to 45 years old
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)
Double 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 Kermanshah University of Medical Sciences
Street address
Building No, 2 of Kermanshah University of Medical Sciences, Shaheid Beheshti Blvd, Kermanshah
City
Kermanshah
Postal code
6714673159
Approval date
2017-01-11, 1395/10/22
Ethics committee reference number
IR.KUMS.REC.1395.596
Health conditions studied
1
Description of health condition studied
Gestational Diabets
ICD-10 code
O24.4
ICD-10 code description
Diabetes Mellitus Arising In Pregnancy
Primary outcomes
1
Description
lifestyle
Timepoint
before intervention, after intervention and one month after intervention
Method of measurement
by using promoting healthy lifestyle questionnaire
Secondary outcomes
1
Description
Self-efficacy
Timepoint
Before intervention, After intervention and One month after intervention
Method of measurement
By using Diabetes Self-efficacy Questionnaire
Intervention groups
1
Description
For the intervention group Consultation in the form of groups of 10 people with cognitive behavioral approach during seven sessions of one and half hours in one of the health centers in Sanandaj, which is a suitable condition, will be executed
Category
Lifestyle
2
Description
For the control group in addition to routine clinic care, after completing the assessments, a training plan will be held.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabet Clinic In Sanandaj City
Full name of responsible person
Nahid Asadi
Street address
Kurdistan University of Medical Sciences, Azadi Square, sanandaj, Iran
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Department of Kermanshah University of Medical Sciences
Full name of responsible person
Kourosh Hamzehei
Street address
Building No. 2 of Kermanshah University of Medical Sciences, Shaheid Beheshti Blvd, Kermanshah
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Department of Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Nahid Asadi
Position
Master Student of Counselling in Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3828 2101
Fax
Email
na.asadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Aazam Bakhteh
Position
Master's Degree of Midwifery, faculty member
Other areas of specialty/work
Street address
University of Nursing and Midwifery, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3828 2101
Fax
Email
aa_bakhteh@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nahid Asadi
Position
Master Student of Counselling in Midwifery
Other areas of specialty/work
Street address
Dolat abad, Isar Square, University of Nursing and Midwifery
City
Kermanshah
Postal code
Phone
+98 83 3828 2101
Fax
Email
na.asadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)