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IRCT20170607034381N12 IRCT 2025-10-12 Shahroud University of Medical Sciences The impact of counseling on self-care of gestational diabetes The effect of acceptance and commitment-based counseling on self-care and obstetric outcomes in women with gestational diabetes. 2025-11-01 anticipated 100 Complete https://irct.ir/trial/86569 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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. N/A Gestational diabetes. Intervention 1: 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. Intervention 2: Control group: Performing routine care for patients in health centers. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentifiable individuals When: 12 months after the results are published To whom: Researchers working in scientific and academic institutions Conditions: According to the terms and conditions of Shahroud Medical Sciences University, the data can be used Where to obtain: raziaharabamery@gmail.com How to obtain: Written request and consent of the Executor of the project and colleagues Comments:
public Razieh Arabameri
Hafte Tir Square
Shahroud Iran (Islamic Republic of) 36147-73943 +98 23 3239 5054 raziaharabamery@gmail.com Shahroud University of Medical Sciences scientific Razieh Arabameri
Hafte Tir Square
Shahroud Iran (Islamic Republic of) 36147-73943 +98 23 3239 5054 raziaharabamery@gmail.com Shahroud University of Medical Sciences Iran (Islamic Republic of) 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 18 years 45 years Female Receive similar training or counseling Having other medical conditions O24.41 Gestational diabetes mellitus in pregnancy Behavior N/A 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 Control group: Performing routine care for patients in health centers Self care. Timepoint: Before and after the intervention. Method of measurement: Glasgow and Tobert Self-Care Questionnaire. Apgar. Timepoint: After delivery. Method of measurement: Hospital file. Infant weight. Timepoint: After delivery. Method of measurement: Hospital file. Cesarean section. Timepoint: Delivery. Method of measurement: Hospital file. Blood pressure. Timepoint: After delivery. Method of measurement: Hospital file. Shahroud University of Medical Sciences Approved 2025-09-23 Research Ethics Committee of Shahroud University of Medical Sciences Hafte Tir Square Shahroud Semnan Iran (Islamic Republic of)