The effect of ACT counseling on self-care in women with gestational diabetes
The effect of ACT counseling on obstetric outcomes in women with gestational diabetes
Design
This intervention is a randomized controlled clinical trial with parallel groups. The sample (100 study participants) will be randomized using block randomization (50 in the control group and 50 in the intervention group).
Settings and conduct
Eligible women referring to the Shahroud city health center will enter the study after the intervention is explained to them.
Participants/Inclusion and exclusion criteria
1. Pregnant women aged 18 to 45 with gestational diabetes (individuals whose fasting blood sugar, one hour or two hours later, after a two-hour oral glucose tolerance test with 75 grams of glucose at 24-28 weeks of pregnancy, was greater than or equal to 92, 180, and 153 milligrams per deciliter, respectively)
2. Having informed consent
3. Iranian nationality
4. Having a reading and writing education
5. Able to communicate verbally
6. Being a resident of Shahroud
7. Gestational age 24 to 30 weeks
8. Single pregnancy
Intervention groups
For the intervention group, 4 weekly ACT counseling sessions will be held at the health center. During the clinical trial, the control group will benefit from routine pregnancy care, and no intervention will be performed by the research team. However, after the trial, the educational content will be provided to them.
The effect of acceptance and commitment-based counseling on self-care and obstetric outcomes in women with gestational diabetes.
Public title
The impact of counseling on self-care of gestational diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women aged 18 to 45 with gestational diabetes (individuals whose fasting blood sugar, one hour or two hours later, after a two-hour oral glucose tolerance test with 75 grams of glucose at 24-28 weeks of pregnancy, was greater than or equal to 92, 180, and 153 milligrams per deciliter, respectively)
Having informed consent
Iranian nationality
Having a reading and writing education
Able to communicate verbally
Being a resident of Shahroud
Gestational age 24 to 30 weeks
Single pregnancy
Exclusion criteria:
Receive similar training or counseling
Having other medical conditions
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:
100
Randomization (investigator's opinion)
Randomized
Randomization description
After determining the sequences, individuals will be selected using a simple random method and assigned to two groups using block randomization with a block size of 4. The procedure is as follows: the group assignments, based on the generated sequence, will be placed in sealed envelopes, and the envelopes will be numbered. For each individual, according to their order of entry into the study, the corresponding numbered envelope will be opened, and they will be assigned to one of the groups without the participant being aware
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
Research Ethics Committee of Shahroud University of Medical Sciences
Street address
Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۴۳
Approval date
2025-09-23, 1404/07/01
Ethics committee reference number
IR.SHMU.REC.1404.092
Health conditions studied
1
Description of health condition studied
Gestational diabetes
ICD-10 code
O24.41
ICD-10 code description
Gestational diabetes mellitus in pregnancy
Primary outcomes
1
Description
Self care
Timepoint
Before and after the intervention
Method of measurement
Glasgow and Tobert Self-Care Questionnaire
2
Description
Apgar
Timepoint
After delivery
Method of measurement
Hospital file
3
Description
Infant weight
Timepoint
After delivery
Method of measurement
Hospital file
4
Description
Cesarean section
Timepoint
Delivery
Method of measurement
Hospital file
5
Description
Blood pressure
Timepoint
After delivery
Method of measurement
Hospital file
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Acceptance and Commitment Therapy (ACT) – 4 Sessions Session 1: Introduction and getting to know group members* Introduction to the Acceptance and Commitment Therapy (ACT) approach* Information about gestational diabetes and the importance of balanced blood glucose levels Education on self-care and its impact on blood sugar control Teaching the concept of mindfulness Training in mindful breathing Identifying thoughts and obstacles related to practicing self-care Homework: Mindfulness exercises assigned for daily practice throughout the week Session 2: Review of previous homework Replacing control strategies with value-based behaviors Teaching that control is not the solution and can worsen the problem Encouraging behavior based on personal values instead of control Distinguishing personal judgments and evaluations from reality Training in observing thoughts and attitudes toward gestational diabetes rather than reacting to them Homework: List strategies to cope with negative emotions Session 3: Review of previous homework Training in diffusion techniques to deal with disturbing thoughts Strengthening connection with the present moment Addressing personal challenges such as communication with doctors, following dietary plans, and incorporating exercise into daily routines Exploring personal values and how to use them to pursue meaningful goals Homework: Design a personalized exercise and dietary plan and commit to following it Session 4:Providing strategies to overcome behavioral change obstacles and planning for continued commitment Reviewing personal values and achievements shared by participants Emphasizing mindful eating and the adoption of healthy dietary habits Enhancing the ability to be fully present in all aspects of life, especially during meals
Category
Behavior
2
Description
Control group: Performing routine care for patients in health centers
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Azima Health Services Center
Full name of responsible person
Razieh Arabameri
Street address
Imam Square
City
Shahroud
Province
Semnan
Postal code
0000000000
Phone
+98 23 3233 1550
Email
info@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Hosein Ebrahimi
Street address
Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۴۳
Phone
+98 23 3239 5054
Email
ebrahimi@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Razieh Arabameri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
36147-73943
Phone
+98 23 3239 5054
Email
raziaharabamery@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Razieh Arabameri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
36147-73943
Phone
+98 23 3239 5054
Email
raziaharabamery@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Razieh Arabameri
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
36147-73943
Phone
+98 23 3239 5054
Email
raziaharabamery@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
12 months after the results are published
To whom data/document is available
Researchers working in scientific and academic institutions
Under which criteria data/document could be used
According to the terms and conditions of Shahroud Medical Sciences University, the data can be used
From where data/document is obtainable
raziaharabamery@gmail.com
What processes are involved for a request to access data/document
Written request and consent of the Executor of the project and colleagues