Protocol summary
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Study aim
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Implementation and evaluation of a weight control program, based on socio-psychological factors, on weighing and pregnancy outcomes in overweight and obese pregnant women
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Design
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This study is a clinical trial with a parallel design and without blinding, which is conducted on 202 pregnant women (101 people in each group). First, health centers in the west and east of Ahvaz were selected and simple random sampling will be done from these centers. The study subjects are selected from the health centers based on the entry and exit criteria, and then they are informed about the study and information confidentiality through a phone call and invited to participate in the research. If the person does not agree, the next person on the list will be contacted to complete the sample size.
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Settings and conduct
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This study will be conducted in the health centers of Ahvaz City on overweight/obese pregnant women who are eligible to enter the study. Pregnant women will be randomly assigned to intervention and control groups.
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Participants/Inclusion and exclusion criteria
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At least 18 years old, body mass index above 25, singleton pregnancy, gestational age within the first trimester, no smoking, no history of bariatric surgery, no medical or psychological conditions affecting weight, no prohibition of physical activity
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Intervention groups
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The intervention group will receive routine care (including prenatal care and nutritional counseling), and the control group will receive routine pregnancy care.
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Main outcome variables
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The average weight gain of the mother during pregnancy, the amount of physical activity of the mother, gestational diabetes, pre-eclampsia, and postpartum infection, the duration of pregnancy, the duration of the stages of delivery, the type of delivery, the weight at the time of birth, the time of breastfeeding, the Apgar score, the hospitalization rate Baby in the hospital
General information
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Reason for update
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Changing the sampling method of the study
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230514058191N1
Registration date:
2023-05-21, 1402/02/31
Registration timing:
prospective
Last update:
2024-10-08, 1403/07/17
Update count:
1
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Registration date
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2023-05-21, 1402/02/31
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-06-05, 1402/03/15
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Expected recruitment end date
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2023-12-21, 1402/09/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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implementation and evaluation of a weight control program, based on Psychosocial factors, on weight gain and pregnancy outcomes in overweight/obese pregnant women
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Public title
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Implementation and evaluation of the developed program for weight control in overweight/obese pregnant women
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
At least 18 years old
singleton pregnancy
No chronic disease (diabetes, high blood pressure, hypothyroidism and hyperthyroidism)
Body mass index above 25
Exclusion criteria:
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
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Age
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From 18 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
202
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-10-15, 1401/07/23
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Ethics committee reference number
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IR.AJUMS.REC.1401.310
Health conditions studied
1
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Description of health condition studied
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Weight control in overweight/obese pregnant women
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ICD-10 code
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O09
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ICD-10 code description
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Supervision of high risk pregnancy
Primary outcomes
1
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Description
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Mother's weight gain during pregnancy
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Timepoint
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After completing the intervention (38-40 weeks of pregnancy)
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Method of measurement
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Use a scale
Secondary outcomes
1
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Description
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The amount of physical activity
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Timepoint
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After completing the intervention (38-40 weeks of pregnancy)
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Method of measurement
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International Physical Activity Questionnaire
2
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Description
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duration of pregnancy
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Timepoint
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During the intervention
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Method of measurement
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Average gestational age
3
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Description
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The duration of the stages of labor
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Timepoint
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during labor
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Method of measurement
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Measuring the time of the first and second stages of labor in minutes
4
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Description
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Type of delivery
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Timepoint
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Time of delivery
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Method of measurement
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The type of delivery includes natural delivery or caesarean section
5
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Description
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Baby Apgar
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Timepoint
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At the time of the birth of the baby
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Method of measurement
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Using the Apgar scale
6
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Description
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Birth weight
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Timepoint
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After birth
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Method of measurement
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scales
7
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Description
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Admitting the baby to the neonatal intensive care unit
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Timepoint
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After the baby is born
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Method of measurement
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Number of hospitalizations
8
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Description
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Time to start breastfeeding
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Timepoint
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After the baby is born
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Method of measurement
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Breastfeeding start time in minutes
9
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Description
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The incidence of gestational diabetes
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Timepoint
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During the intervention
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Method of measurement
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Two-hour blood sugar test
10
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Description
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The rate of preeclampsia
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Timepoint
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During the intervention
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Method of measurement
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Gynecologist diagnosis
11
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Description
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Postpartum infection rate
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Timepoint
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after delivery
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Method of measurement
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Gynecologist diagnosis
Intervention groups
1
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Description
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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.
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Category
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N/A
2
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Description
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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.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The data can be published after the completion of the thesis
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When the data will become available and for how long
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One year after finishing the thesis
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To whom data/document is available
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Jundishapur University of Medical Sciences, Ahvaz
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Under which criteria data/document could be used
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After analysis, the data will be available to others through publication in scientific research journals.
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From where data/document is obtainable
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elahe banafshe,
banafsheelahe@gmail.com
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What processes are involved for a request to access data/document
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Information will be available through printing the article. But if the person wants more information, he can express his request through email.
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Comments
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