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IRCT20230514058191N1 IRCT 2023-05-21 Ahvaz University of Medical Sciences Implementation and evaluation of the developed program for weight control in overweight/obese pregnant women implementation and evaluation of a weight control program, based on Psychosocial factors, on weight gain and pregnancy outcomes in overweight/obese pregnant women 2023-06-05 anticipated 202 Complete https://irct.ir/trial/70179 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: First, a list of health centers in the west and east of Ahvaz will be prepared and a number will be assigned to each center. Then, two health centers from the west of Ahvaz and two health centers from the east of Ahvaz will be selected by lottery. Simple random sampling will be done from the aforementioned health centers and bases. According to the research entry and exit criteria, a list of people will be prepared from the system and a number will be assigned to each person. Then, people will be selected using a random number table, and during a phone call, information about the research, how it will be done, and the confidentiality of the information will be given to the people and they will be invited to participate in the study. If there is no agreement, the next person on the list will be contacted to obtain the desired sample size. N/A Weight control in overweight/obese pregnant women. Intervention 1: Intervention group: In the intervention group, from the 12th week of pregnancy, three face-to-face training sessions on weight management during pregnancy (one session per week, in three consecutive weeks) will be held in two health centers (one in the west and one in the east of Ahvaz). In the intervention group, all 25 pregnant women will be placed in one group and they will be invited to attend the training session at the health center on the designated day. Before the start of the training class, demographic and midwifery questionnaires, nutritional and physical activity screening questionnaires will be completed by the research units. Measurement of height, weight and determination of BMI will be done by the researcher. At the end of the first session, a pamphlet on the role of husbands in the physical and emotional support of pregnant mothers and a food pyramid poster and scales in food groups will be provided to women. After holding training sessions, "reminder text messages" will be sent to women twice a week. The content of these reminder messages will be about healthy diet, physical activity, optimal weight gain during pregnancy, as well as motivational messages to start activities and follow a healthy diet, stress control, financial management and time management. These messages will continue until the end of pregnancy. It will also be recommended that women write down their daily physical activity and diet during pregnancy. A virtual group will be formed to answer women's questions about weight control during pregnancy. Also, a pamphlet about the challenges of weight control during pregnancy in obese or overweight women will be provided to the midwives of the intervention group's health centers. At the end of pregnancy (38-40 weeks), nutrition and physical activity screening questionnaires will be completed again by mothers. The pregnancy and childbirth outcomes questionnaire will be collected by the researcher visiting the health center and hospital. Intervention 2: Control group: In the routine care group, the BMI of the research units will be calculated by the researcher and the screening questionnaires for nutrition and physical activity in early pregnancy (first trimester) will be completed by the research units. Pregnant women in the control group will receive prenatal care from health centers. Providing care in this group will be routine; In this way, the midwife located in the health center will provide prenatal care according to the national protocol, and the researcher will not interfere in their pregnancy care. In the last weeks of pregnancy (38-40 weeks), the nutrition screening questionnaire and the physical activity questionnaire will be completed again by the research units. The maternity information questionnaire will be collected by the researcher visiting the health center and hospital. Yes - There is a plan to make this available What will be shared: The data can be published after the completion of the thesis When: One year after finishing the thesis To whom: Jundishapur University of Medical Sciences, Ahvaz Conditions: After analysis, the data will be available to others through publication in scientific research journals. Where to obtain: elahe banafshe, banafsheelahe@gmail.com How to obtain: Information will be available through printing the article. But if the person wants more information, he can express his request through email. Comments:
public Nahid Javadi Far
Golestan Blvd., Jundishapur University of Medical Sciences, Ahvaz, Faculty of Nursing and Midwifery, Department of Midwifery
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8331 nahidjavadifar_341@yahoo.com Ahvaz University of Medical Sciences scientific elahe banafshe
Golestan highway, next to Jundi Shapur University of Medical Sciences, Sisters dormitory complex
Ahvaz Iran (Islamic Republic of) 61358-15751 +98 61 3311 2652 banafsheelahe@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) At least 18 years old singleton pregnancy No chronic disease (diabetes, high blood pressure, hypothyroidism and hyperthyroidism) Body mass index above 25 18 years no limit Female People who, according to themselves, are under the supervision of a doctor due to mental disorders. People who, according to themselves, had a history of hospitalization in psychiatric wards. Gestational age above 12 weeks Prohibition of movement and exercise during pregnancy smoking Bariatric surgery history O09 Supervision of high risk pregnancy N/A N/A Intervention group: In the intervention group, from the 12th week of pregnancy, three face-to-face training sessions on weight management during pregnancy (one session per week, in three consecutive weeks) will be held in two health centers (one in the west and one in the east of Ahvaz). In the intervention group, all 25 pregnant women will be placed in one group and they will be invited to attend the training session at the health center on the designated day. Before the start of the training class, demographic and midwifery questionnaires, nutritional and physical activity screening questionnaires will be completed by the research units. Measurement of height, weight and determination of BMI will be done by the researcher. At the end of the first session, a pamphlet on the role of husbands in the physical and emotional support of pregnant mothers and a food pyramid poster and scales in food groups will be provided to women. After holding training sessions, "reminder text messages" will be sent to women twice a week. The content of these reminder messages will be about healthy diet, physical activity, optimal weight gain during pregnancy, as well as motivational messages to start activities and follow a healthy diet, stress control, financial management and time management. These messages will continue until the end of pregnancy. It will also be recommended that women write down their daily physical activity and diet during pregnancy. A virtual group will be formed to answer women's questions about weight control during pregnancy. Also, a pamphlet about the challenges of weight control during pregnancy in obese or overweight women will be provided to the midwives of the intervention group's health centers. At the end of pregnancy (38-40 weeks), nutrition and physical activity screening questionnaires will be completed again by mothers. The pregnancy and childbirth outcomes questionnaire will be collected by the researcher visiting the health center and hospital. Control group: In the routine care group, the BMI of the research units will be calculated by the researcher and the screening questionnaires for nutrition and physical activity in early pregnancy (first trimester) will be completed by the research units. Pregnant women in the control group will receive prenatal care from health centers. Providing care in this group will be routine; In this way, the midwife located in the health center will provide prenatal care according to the national protocol, and the researcher will not interfere in their pregnancy care. In the last weeks of pregnancy (38-40 weeks), the nutrition screening questionnaire and the physical activity questionnaire will be completed again by the research units. The maternity information questionnaire will be collected by the researcher visiting the health center and hospital. Mother's weight gain during pregnancy. Timepoint: After completing the intervention (38-40 weeks of pregnancy). Method of measurement: Use a scale. The amount of physical activity. Timepoint: After completing the intervention (38-40 weeks of pregnancy). Method of measurement: International Physical Activity Questionnaire. Duration of pregnancy. Timepoint: During the intervention. Method of measurement: Average gestational age. The duration of the stages of labor. Timepoint: during labor. Method of measurement: Measuring the time of the first and second stages of labor in minutes. Type of delivery. Timepoint: Time of delivery. Method of measurement: The type of delivery includes natural delivery or caesarean section. Baby Apgar. Timepoint: At the time of the birth of the baby. Method of measurement: Using the Apgar scale. Birth weight. Timepoint: After birth. Method of measurement: scales. Admitting the baby to the neonatal intensive care unit. Timepoint: After the baby is born. Method of measurement: Number of hospitalizations. Time to start breastfeeding. Timepoint: After the baby is born. Method of measurement: Breastfeeding start time in minutes. The incidence of gestational diabetes. Timepoint: During the intervention. Method of measurement: Two-hour blood sugar test. The rate of preeclampsia. Timepoint: During the intervention. Method of measurement: Gynecologist diagnosis. Postpartum infection rate. Timepoint: after delivery. Method of measurement: Gynecologist diagnosis. Ahvaz University of Medical Sciences Approved 2022-10-15 Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences Golestan Boulevard; university city; Vice President of Research and Technology Development, Jundishapur University of Medical Sciences, Ahvaz; ground floor; Room 4 Ahvaz Khouzestan Iran (Islamic Republic of)