The Effect of Couples Counseling on Social Support and Glucose Tolerance Test in Mothers with Gestational Diabetes
Design
The present randomized clinical trial will consist of a control and experimental group with 96 couples, which will be used for randomization by blocking method using random allocation software.
Settings and conduct
The research environment will be 4 health centers in south of Tehran. mothers in the last month of pregnancy will enter the study if they want to have the inclusion criteria if they wish after obtaining informed consent. Due to the nature of the study there is no possibility of blindness.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- informed consent couples
- Mothers aged 18 to 45 years
- Diagnosis of gestational diabetes
- The presence of the wife during the consultation
- couple's primary education
Exclusion criteria:
- Overt Diabetes
- Death of a spouse or divorce
- Non-Iranian
Intervention groups
The control group will receive routine care by health care providers of the health center and couples counseling will be held in 2 sessions for the intervention group, the first session will be done in person and the second session will be virtual counseling.
Main outcome variables
The status of social support of the spouse after childbirth;
The status of postpartum glucose tolerance test doing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231103059938N1
Registration date:2023-12-23, 1402/10/02
Registration timing:prospective
Last update:2023-12-23, 1402/10/02
Update count:0
Registration date
2023-12-23, 1402/10/02
Registrant information
Name
Zeinab Shakori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6642 9878
Email address
zeinabshakori2023@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Couples Counseling on Social Support and postpartum Glucose Tolerance Test doing in Mothers with Gestational Diabetes
Public title
The Effect of Couples Counseling on Prevention of Diabetes in Mothers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Obtaining informed consent from couples to participate in the study
Mothers aged 18 to 45 years
Diagnosis of gestational diabetes during pregnancy according to a doctor's opinion
Have at least a couple's primary education
Exclusion criteria:
Overt diabetes
Death of a spouse or divorce
Non-Iranian Nationality
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
The research environment will be the health centers of south of Tehran, which will be selected from among the centers with the highest number of pregnant mothers referring to the accident of 4 centers. The number of samples will be 96 couples with a 10% probability of loss, of which 48 will be divided into two groups of control and experiment. In each center, 24 couples were selected by available sampling method and through random allocation software by blocking method to 6 blocks 4 mothers will be divided in each health center with 12 mothers in the control group and 12 mothers in the experimental group.
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 Tehran University of Medical Sciences
Street address
13th Floor, Block A, Central Headquarters of Ministry of Health and Medical Education, Iran Simaye St., Ghods Town, Qods Town, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2023-11-25, 1402/09/04
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.456
Health conditions studied
1
Description of health condition studied
Gestational Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Glucose tolerance test with 75 grams of glucose
Timepoint
6 weeks after delivery
Method of measurement
Checklist
2
Description
Husband's social support after childbirth
Timepoint
First and sixth week after delivery
Method of measurement
The Postpartum Partner Support Scale of Denise et al
Secondary outcomes
1
Description
Glucose tolerance test values with 75 grams of glucose
Timepoint
6 weeks after delivery
Method of measurement
Laboratory Test
Intervention groups
1
Description
Intervention group: For the intervention group, in addition to routine care, couples counseling will be held in 2 sessions, the first session will be conducted in the form of one-hour in-person counseling (for couples) on 3-5 days after delivery (at the same time as newborn screening) and the second session will be virtual counseling for one hour at week 3 after birth. The content of the consultation in the first session includes: problems and possible questions of mothers and husbands in controlling postpartum complications of gestational diabetes mellitus and healthy lifestyle education during postpartum, the risk of type 2 diabetes in the coming years and short-term and long-term complications for mother and child in adulthood, importance of screening test in diagnosis of type 2 diabetes and the possibility of prevention or Treatment in the early stages if diagnosed early with lifestyle interventions (weight control, proper diet, physical activity and exercise), how spouses support mothers with gestational diabetes in postpartum, lactation, mental health improvement and postpartum depression prevention. In the second session, feedback will be taken from participants and necessary reviews will be made in consultation content based on their needs.
Category
Prevention
2
Description
Control group: Routine care will be received by health care providers at the health center.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers south of Tehran
Full name of responsible person
Zeinab Shakori
Street address
South Tehran Health Center, Abbas Shafiee Alley, Vesal Shirazi St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1413853781
Phone
+98 21 6695 0069
Fax
+98 21 6697 8053
Email
Behdasht-Jonoob-Tehran@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Akbari Sari
Street address
Unit of Research and Technology Affairs, 6th Floor, Unit 605, Sixth Floor, Headquarters of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Fax
+98 21 8898 9664
Email
research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zeinab Shakori
Position
MSc Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Unit 6, No. 6, Sabokro Karimi Alley, North Eskandari St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419763536
Phone
+98 21 6642 9878
Email
zeinabshakori2023@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehrnaz Geranmayeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Zone 6- Nosrat St.- School of Nursing and Midwifery, Tehran University of Medical Sciences- Vice Chancellor for Research
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4567
Email
geranmay@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zeinab Shakori
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
North Eskandari St., Sabkaro Karimi Alley, No. 6, Unit 6
City
Tehran
Province
Tehran
Postal code
1419763536
Phone
+98 21 6642 9878
Fax
Email
zeinabshakori2023@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Participants' demographic data will be shared after making people unidentifiable
When the data will become available and for how long
The start of access will be after the results are printed.
To whom data/document is available
Scientific researchers and health care workers
Under which criteria data/document could be used
Observing the rules based on the article
From where data/document is obtainable
Zeinab Shakori (MSc. Student of Midwifery Tehran University of Medical Sciences): zeinabshakori2023@gmail.com
Mehrnaz Geranmayeh (Assistant Professor of Medical Education, Tehran University of Medical Sciences): geranmay@tums.ac.ir
What processes are involved for a request to access data/document