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IRCT20250408065253N1 IRCT 2025-04-14 Qazvin University of Medical Sciences The effect of non-pharmacological lifestyle modification intervention on self-efficacy, lifestyle, and life satisfaction in women with gestational diabetes. Investigating the effect of non-pharmacological lifestyle modification intervention on self-efficacy, health-promoting lifestyle behaviors, and life satisfaction in women with gestational diabetes: A randomized clinical trial study 2025-04-18 anticipated 60 Complete https://irct.ir/trial/82827 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, a block randomization method with variable block sizes (4 and 6) was used to maintain a uniform distribution of participants in the two intervention and control groups. The randomization unit was the individual; each participant was independently assigned to one of the two groups. Stratified randomization was used to increase the balance between the groups in terms of age (under 30 years and 30 years and older) and education level (diploma and below, higher than diploma). The random sequence generation tool was SPSS statistical software version 26, which was implemented by an independent researcher (not involved in the data collection process or analysis of the results). The random sequence was first generated completely by the software and then the group allocation was concealed using serial numbering and opaque, unpredictable, and sealed envelopes. Allocation concealment was performed in such a way that the person responsible for registering and entering participants into the study was not aware of the allocation sequence, and the envelopes were opened sequentially only when the participant entered and confirmed the entry conditions, Blinding description: This study is a single-blind clinical trial. Therefore, blinding will be implemented in the assessors who will analyze the study data. For this purpose, the questionnaires that will be completed by the researchers in all two groups will be identified by an agreement between the researchers with one of the English letters at the top, indicating which of the study groups the questionnaire was completed by the participants; however, the assessors analyzing the data will not be aware of the agreement between the researchers that has been assigned to each group. N/A Gestational Diabetes. Intervention 1: Intervention group: Intervention group: Participants in this group received a non-pharmacological educational program based on lifestyle modification. The program content included training in the following areas: healthy and balanced nutrition during pregnancy, appropriate physical activity for pregnant women, stress management and mind-relaxation strategies, improving sleep quality, strengthening social support and interpersonal communication. The program was held in person at the medical center in the form of 6 weekly sessions (each session about 90 minutes). Also, supplementary materials including multimedia files, nutritional guides and relaxation exercises were sent to the participants via messenger so that the education could continue continuously. The educational content was developed by members of the research team in collaboration with health education specialists and was based on reliable and up-to-date pregnancy health guides. Intervention 2: Control group: This group will have routine and ongoing interventions, including receiving medication and conventional counseling. Yes - There is a plan to make this available What will be shared: Only a portion of the data, such as information related to the main outcome and general demographic information, can be shared. When: Access period starts 3 months after results are published. To whom: Doctors, nurses, midwives, researchers working in universities, medical centers and hospitals, clinical psychologists Conditions: For use for scientific purposes, with reference to the source used and request for the journal in which the article will be published. Where to obtain: Communication via email (if sharing information is legally and ethically possible, such as sharing the primary outcome of the study) To receive information, contact the following email address: Corresponding author's email: leiladehghankar66@gmail.com How to obtain: Find the email of the responsible author, state the reason, and comply with ethical and legal matters; in this case, a quick response will be given to the requesting person. Comments:
public Leila Dehghankar
Nor
Qazvin Iran (Islamic Republic of) 3415613911 +98 28 3333 8034 leiladehghankar66@gmail.com Qazvin University of Medical Sciences scientific Leila Dehghankar
Nor
Qazvin Iran (Islamic Republic of) 3415613911 +98 28 3333 8034 leiladehghankar66@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) 18 and 40 years old Having a definitive diagnosis of gestational diabetes by a gynecologist or physician Gestational age between 24 and 28 weeks Willingness to participate in the study and written informed consent Ability to read and write No concurrent chronic debilitating diseases (as determined by a doctor) 18 years 40 years Female Not filling the questionarrie before the beginning of the intervention No participation in two consecutive sessions O24.4 Gestational diabetes mellitus Lifestyle Treatment - Drugs Intervention group: Intervention group: Participants in this group received a non-pharmacological educational program based on lifestyle modification. The program content included training in the following areas: healthy and balanced nutrition during pregnancy, appropriate physical activity for pregnant women, stress management and mind-relaxation strategies, improving sleep quality, strengthening social support and interpersonal communication. The program was held in person at the medical center in the form of 6 weekly sessions (each session about 90 minutes). Also, supplementary materials including multimedia files, nutritional guides and relaxation exercises were sent to the participants via messenger so that the education could continue continuously. The educational content was developed by members of the research team in collaboration with health education specialists and was based on reliable and up-to-date pregnancy health guides. Control group: This group will have routine and ongoing interventions, including receiving medication and conventional counseling. Health-promoting lifestyle behaviors score was based on the HPLP-II questionnaire (Health-Promoting Lifestyle Profile II), which was measured in two stages before the intervention and 6 weeks after it. Timepoint: Measurement of primary outcome variables will be conducted at two time points:At baseline (before the intervention)Six weeks after the end of the educational intervention. Method of measurement: To measure this variable, the Health Promoting Lifestyle Profile II questionnaire is used. This questionnaire consists of 52 items in six different dimensions and uses a 4-point Likert scale for scoring. Participants' self-efficacy score was based on the standard Scherrer Self-Efficacy Scale, which was measured before the intervention and 6 weeks after the end of the intervention. Timepoint: Measurement of primary outcome variables will be conducted at two time points:At baseline (before the intervention)Six weeks after the end of the educational intervention. Method of measurement: The standard Scherrer Self-Efficacy Scale (SGS) is used to measure self-efficacy. This instrument has 17 items that are scored using a 5-point Likert scale. Participants' life satisfaction score is measured using the Deaner Satisfaction With Life Scale (SWLS) at two time points before and after the intervention. Timepoint: Measurement of primary outcome variables will be conducted at two time points:At baseline (before the intervention)Six weeks after the end of the educational intervention. Method of measurement: The Diner Satisfaction With Life Scale is used to measure life satisfaction. This scale consists of 5 items that are rated on a 7-point Likert scale. Qazvin University of Medical Sciences Approved 2025-03-08 Research Ethics Committees of Qazvin University of Medical Sciences 1st Moaddat Alley, Moaddat Street, Shahid Beheshti Boulevard Qazvin Qazvin Iran (Islamic Republic of)