]>
IRCT20211229053562N1 IRCT 2022-04-18 Tarbiat Modares University A nutritional intervention study in pregnancy based on mobile health application Evaluating the effect of using the most appropriate existing mobile health application and an innovative mobile health application to conduct a nutritional intervention study in pregnancy 2022-05-22 anticipated 60 Complete https://irct.ir/trial/62369 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: First, the generation of random allocation sequence is done using a table of random numbers, and the two study groups are concealed as group A and group B, and then the participants will be assigned to one of the two groups according to the generated sequence. 2 Condition 1: pregnancy. Condition 2: nutrition. Intervention 1: The first Intervention group: The most suitable mobile health application available will be determined based on "the Mobile App Rating Scale" (MARS) in a preliminary study on nutritional applications available in the field of pregnancy. Mothers in the first intervention group will then receive a nutritional intervention based on the application of choice along with the necessary training on how to use the application, in addition to routine care during the Covid 19 pandemic, which has been reduced from 8 sessions to 4-5 sessions. The intervention will start from the 20th week of pregnancy. They will receive information about how to use the application, and the intervention will start from the 20th week of pregnancy. Routine follow-up and prenatal care will be provided until delivery, and maternal information including blood pressure, weight, and pregnancy complications will be recorded. In the follow-up process, the use of the nutritional intervention application will also be assessed. Intervention 2: The second intervention group: Mothers in the second intervention group, in addition to routine prenatal care during the Covid 19 period, which has been reduced from 8 sessions to 4-5 face-to-face sessions, will receive an innovative mobile health application developed in the field of nutritional intervention by researchers in this same study. They will receive information about how to use the application and the intervention will start from the 20th week of pregnancy. Routine follow-up and prenatal care will be provided until delivery, and maternal information including blood pressure, weight, and pregnancy complications will be recorded. In the follow-up process, the use of the nutritional intervention application will also be assessed. Intervention 3: Control group: Mothers in the control group will receive only routine pregnancy care, which according to the clinical guideline of Covid 19 disease in pregnancy, in low-risk pregnancies, the number of face-to-face care is 4-5 times according to the conditions of the residence area and absentee care is 4 times. Routine prenatal care and follow-up will be performed until delivery, and prenatal care information including blood pressure, weight, and pregnancy complications will be recorded. Yes - There is a plan to make this available What will be shared: At the end of the study, the final report will be provided in 2 forms: - A theses for obtaining an MSc degree in Tarbiat Modares University - The final report of the approved research by the Iran National Scientific Foundation In both reports, details of the study protocol, statistical analysis map, and informed consent form will be mentioned. In addition, after the publication of the final report and also the articles extracted from the data of this project, at the request of researchers and scientific centers related to the research topic, data file, study protocol, statistical analysis map, informed consent form, and codes used in the analysis will be provided for them. When: After the end of the study, and publication of the mentioned reports To whom: Researchers and scientific centers related to the research topic Conditions: In case of sending a written request via e-mail, and in order to use the results of the study in executive and research fields in order to promote pregnancy health Where to obtain: Person in charge of the scientific research, Lida Moghaddam-Banaem How to obtain: - Sending an email to the person in charge of the scientific research - Sending the mentioned request to the members of the research team - Assessment of the request by the research team - Sending the requested items to the applicant person or center, if approved by the research team, by the person in charge of the scientific research Comments:
public Lida Moghaddam-Banaem
Department of Reproductive Health and Midwifery, Faculty of Medical Sciences, Tarbiat Modares University, Al-e-Ahmad Highway
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 3857 moghaddamb@modares.ac.ir Tarbiat Modares University scientific Lida Moghaddam-Banaem
Department of Reproductive Health and Midwifery, Faculty of Medical Sciences< Tarbiat Modares University, Al-e-Ahmad Highway
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 3857 moghaddamb@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iranian citizenship Resident of Tehran province 18 -45 years old Singleton pregnancy Having a smartphone Ability to read and speak Persian to understand the content of the application Gestational age less than 20 weeks 18 years 45 years Female Chronic systemic diseases such as diabetes, hypertension, respiratory diseases, kidney diseases, and polycystic ovary syndrome, ... Eating disorders Use of any medication except for routine pregnancy supplements Any movement disorders Lifestyle Lifestyle N/A The first Intervention group: The most suitable mobile health application available will be determined based on "the Mobile App Rating Scale" (MARS) in a preliminary study on nutritional applications available in the field of pregnancy. Mothers in the first intervention group will then receive a nutritional intervention based on the application of choice along with the necessary training on how to use the application, in addition to routine care during the Covid 19 pandemic, which has been reduced from 8 sessions to 4-5 sessions. The intervention will start from the 20th week of pregnancy. They will receive information about how to use the application, and the intervention will start from the 20th week of pregnancy. Routine follow-up and prenatal care will be provided until delivery, and maternal information including blood pressure, weight, and pregnancy complications will be recorded. In the follow-up process, the use of the nutritional intervention application will also be assessed. The second intervention group: Mothers in the second intervention group, in addition to routine prenatal care during the Covid 19 period, which has been reduced from 8 sessions to 4-5 face-to-face sessions, will receive an innovative mobile health application developed in the field of nutritional intervention by researchers in this same study. They will receive information about how to use the application and the intervention will start from the 20th week of pregnancy. Routine follow-up and prenatal care will be provided until delivery, and maternal information including blood pressure, weight, and pregnancy complications will be recorded. In the follow-up process, the use of the nutritional intervention application will also be assessed. Control group: Mothers in the control group will receive only routine pregnancy care, which according to the clinical guideline of Covid 19 disease in pregnancy, in low-risk pregnancies, the number of face-to-face care is 4-5 times according to the conditions of the residence area and absentee care is 4 times. Routine prenatal care and follow-up will be performed until delivery, and prenatal care information including blood pressure, weight, and pregnancy complications will be recorded. Pregnancy weight gain. Timepoint: Beginning of the study (before the intervention), 31 to 34 weeks of gestation, time of delivery. Method of measurement: Will be extracted from the mother's prenatal care record. Anthropometric indices of the newborn including weight, height, and head circumference. Timepoint: At birth. Method of measurement: Based on the measurements recorded on the newborn's birth card. Gestational age at birth. Timepoint: Time of delivery. Method of measurement: Will be extracted from the mother's prenatal care and delivery records. Iran National Science Foundation Tarbiat Modares University Iran National Science Foundation Approved 2021-12-25 Ethics committee of Tarbiat Modares University Ai-e-Ahmad Highway, Tarbiat Modares University Tehran Tehran Iran (Islamic Republic of)