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IRCT20221025056295N1 IRCT 2022-10-31 Kashan University of Medical Sciences Effect of a mobile application on weight gain control of pregnant women Study the effect of a mobile-based application on weight gain control of pregnant women during pregnancy 2022-12-21 anticipated 100 Complete https://irct.ir/trial/66504 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This study has two groups. The control group includes pregnant women who receive standard and usual care, and the intervention group includes pregnant women who, in addition to standard and usual care, use a smartphone-based application, Randomization description: In this randomized controlled trial study, all pregnant women (overweight and non-overweight) are divided into two intervention (50 people) and control (50 people) groups by block randomization method. Randomization is done by the block method in such a way that first all the 4 blocks containing two codes A and B are prepared (6 blocks), then the numbers one to six are selected using the table of random numbers (20 numbers). ) and the corresponding block will be written based on the randomly selected number. With this, a sequence of 80 letters A and B will be obtained. Each of the sample will have a number from 1 to 80 (20 people to take into account attrition) and will receive an A or B code based on the list of letters based on the number of each person. Both groups will be almost the same. It should be mentioned that the effect of confounding variables will be controlled by the block randomization method. N/A pregnancy. Intervention 1: Intervention group: includes pregnant women who use intervention in addition to standard and usual care. The intervention includes an application that was designed in a previous study by a team of health information management specialists and gynecologists using Adobe Air software under the Android operating system. It is an application with various capabilities, including providing educational information, recording information, calculating gestational age, birth date and body mass index, setting reminders and communicating with the doctor, which helps pregnant women to control weight gain during pregnancy. In this study, the capabilities of providing educational information, recording information and calculating gestational age, birth date and body mass index are used to measure the results of the study. Intervention 2: Control group: includes pregnant women who are under their standard and usual care. Yes - There is a plan to make this available What will be shared: Data file of participants and statistical analysis in SPSS file format will be available. Clinical study data in article format It will be published. When: 6 months after the publication of the final results of the study. To whom: The final results of the study for the public and the data file and statistical analysis if requested by scientific institutions. Conditions: Only scientific and academic institutions can send data access requests for scientific analysis. Where to obtain: Kashan University of Medical Sciences, Department of Health Information Technology and Management, Safoora Ramezani. How to obtain: The application should be sent by post to the Health Information Technology and Management Department of Kashan University of Medical Sciences or to the following email: Ramezani-s@kaums.ac.ir Comments:
public Mehrdad Farzandipour
Qutb Rawandi Blvd
Kashan Iran (Islamic Republic of) 8715973449 0098 31 55540021-25 farzandipour_m@kaums.ac.ir Kashan University of Medical Sciences scientific Zahra Vehedpoor
Qutb Rawandi Blvd
Kashan Iran (Islamic Republic of) 8715973474 +98 31 5554 0026 zahravehedpoor@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Pregnant women with overweight (body mass index above 25) and without overweight (body mass index below 25) with a gestational age of 13 weeks. Have a smart mobile phone with an Android operating system that has the ability to install an application. Have documents of singleton pregnancy. Have a minimum level of primary education. Age above 18 years. 18 years no limit Female Addiction or use of alcohol and drugs. Change of living place during the study period. Behavior Behavior Intervention group: includes pregnant women who use intervention in addition to standard and usual care. The intervention includes an application that was designed in a previous study by a team of health information management specialists and gynecologists using Adobe Air software under the Android operating system. It is an application with various capabilities, including providing educational information, recording information, calculating gestational age, birth date and body mass index, setting reminders and communicating with the doctor, which helps pregnant women to control weight gain during pregnancy. In this study, the capabilities of providing educational information, recording information and calculating gestational age, birth date and body mass index are used to measure the results of the study. Control group: includes pregnant women who are under their standard and usual care. Weight gain. Timepoint: From the 13th week of pregnancy monthly until the last week of pregnancy. Method of measurement: In order to measure the weight, all subjects of the monthly study are weighed without shoes and with as little clothing as possible. To weigh pregnant women, the scale (seca) available in the specialized obstetrics and gynecology office and clinic of the project executive will be used, and the correct performance of the scale will be evaluated by weighing a 500-gram weight at each weighing session. Food intake. Timepoint: From the 13th week of pregnancy weekly until the last week of pregnancy. Method of measurement: To measure food intake, the food frequency questionnaire, which is a standard questionnaire, will be used. Physical activity. Timepoint: From the 13th week of pregnancy weekly until the last week of pregnancy. Method of measurement: In order to measure physical activity, the International Physical Activity Questionnaire, which is a standard questionnaire, will be used. Kashan University of Medical Sciences Approved 2022-10-04 Ethics Committee in Research Faculty of Nursing and Midwifery, Health and Paramedicine - Kashan Univ Qutb Rawandi Blvd kashan Isfehan Iran (Islamic Republic of)