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IRCT20231103059938N1 IRCT 2023-12-23 Tehran University of Medical Sciences The Effect of Couples Counseling on Prevention of Diabetes in Mothers The Effect of Couples Counseling on Social Support and postpartum Glucose Tolerance Test doing in Mothers with Gestational Diabetes 2024-01-21 anticipated 96 Complete https://irct.ir/trial/73787 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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. N/A Gestational Diabetes. Intervention 1: 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. Intervention 2: Control group: Routine care will be received by health care providers at the health center. Yes - There is a plan to make this available What will be shared: Participants' demographic data will be shared after making people unidentifiable When: The start of access will be after the results are printed. To whom: Scientific researchers and health care workers Conditions: Observing the rules based on the article Where to obtain: 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 How to obtain: Email to the main authors of the article Comments:
public Zeinab Shakori
Unit 6, No. 6, Sabokro Karimi Alley, North Eskandari St., Tehran, Iran
Tehran Iran (Islamic Republic of) 1419763536 +98 21 6642 9878 zeinabshakori2023@gmail.com Tehran University of Medical Sciences scientific Mehrnaz Geranmayeh
Zone 6- Nosrat St.- School of Nursing and Midwifery, Tehran University of Medical Sciences- Vice Chancellor for Research
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4567 geranmay@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 45 years Both Overt diabetes Death of a spouse or divorce Non-Iranian Nationality E08 Diabetes mellitus due to underlying condition Prevention N/A 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. Control group: Routine care will be received by health care providers at the health center. Glucose tolerance test with 75 grams of glucose. Timepoint: 6 weeks after delivery. Method of measurement: Checklist. 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. Glucose tolerance test values with 75 grams of glucose. Timepoint: 6 weeks after delivery. Method of measurement: Laboratory Test. Tehran University of Medical Sciences Approved 2023-11-25 Ethics Committee of Tehran University of Medical Sciences 13th Floor, Block A, Central Headquarters of Ministry of Health and Medical Education, Iran Simaye St., Ghods Town, Qods Town, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)