implementation and evaluation of a weight control program, based on Psychosocial factors, on weight gain and pregnancy outcomes in overweight/obese pregnant women
Implementation and evaluation of a weight control program, based on socio-psychological factors, on weighing and pregnancy outcomes in overweight and obese pregnant women
Design
The clinical trial will have a control group, with a parallel design, without blinding, on 202 pregnant women (101 people in each group). For randomization, people will be divided into two groups from a random block of 4 and with an allocation ratio of 1:1. To conceal the allocation, the type of intervention will be written on paper and placed inside consecutively numbered opaque envelopes.
Settings and conduct
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. The intervention group, while receiving routine care, will be under care with the developed program. Then the outcomes of the mother and baby will be compared in two groups.
Participants/Inclusion and exclusion criteria
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
Intervention groups
The intervention group will receive routine care (including prenatal care and nutritional counseling), and the control group will receive routine pregnancy care.
Main outcome variables
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
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230514058191N1
Registration date:2023-05-21, 1402/02/31
Registration timing:prospective
Last update:2023-05-21, 1402/02/31
Update count:1
Registration date
2023-05-21, 1402/02/31
Registrant information
Name
elahe banafshe
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 5630
Email address
banafsheelahe@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-05, 1402/03/15
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
implementation and evaluation of a weight control program, based on Psychosocial factors, on weight gain and pregnancy outcomes in overweight/obese pregnant women
Public title
Implementation and evaluation of the developed program for weight control in overweight/obese pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
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
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
202
Randomization (investigator's opinion)
Randomized
Randomization description
After the initial selection of samples by easy sampling method, people will be divided into two groups using random block of 4; In this way, after listing the possible states of blocks of 4 and assigning a number to each of them using a computerized random number table with a ratio of 1:1, people will be placed in the intervention and control groups. To hide the allocation, the type of intervention will be written on paper and placed inside numbered envelopes, and the envelopes will be handed over to one of the midwives who is a member of the health center staff; In this way, the researcher and the participant will not know the type of intervention until the start of the intervention.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences
Street address
Golestan Boulevard; university city; Vice President of Research and Technology Development, Jundishapur University of Medical Sciences, Ahvaz; ground floor; Room 4
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2022-10-15, 1401/07/23
Ethics committee reference number
IR.AJUMS.REC.1401.310
Health conditions studied
1
Description of health condition studied
Weight control in overweight/obese pregnant women
ICD-10 code
O09
ICD-10 code description
Supervision of high risk pregnancy
Primary outcomes
1
Description
Mother's weight gain during pregnancy
Timepoint
After completing the intervention (38-40 weeks of pregnancy)
Method of measurement
Use a scale
Secondary outcomes
1
Description
The amount of physical activity
Timepoint
After completing the intervention (38-40 weeks of pregnancy)
Method of measurement
International Physical Activity Questionnaire
2
Description
duration of pregnancy
Timepoint
During the intervention
Method of measurement
Average gestational age
3
Description
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
4
Description
Type of delivery
Timepoint
Time of delivery
Method of measurement
The type of delivery includes natural delivery or caesarean section
5
Description
Baby Apgar
Timepoint
At the time of the birth of the baby
Method of measurement
Using the Apgar scale
6
Description
Birth weight
Timepoint
After birth
Method of measurement
scales
7
Description
Admitting the baby to the neonatal intensive care unit
Timepoint
After the baby is born
Method of measurement
Number of hospitalizations
8
Description
Time to start breastfeeding
Timepoint
After the baby is born
Method of measurement
Breastfeeding start time in minutes
9
Description
The incidence of gestational diabetes
Timepoint
During the intervention
Method of measurement
Two-hour blood sugar test
10
Description
The rate of preeclampsia
Timepoint
During the intervention
Method of measurement
Gynecologist diagnosis
11
Description
Postpartum infection rate
Timepoint
after delivery
Method of measurement
Gynecologist diagnosis
Intervention groups
1
Description
Intervention group:In the intervention group, for every 20 to 25 pregnant women who enter the study at the end of the first trimester of pregnancy and are eligible, three group training and discussion sessions will be held. These meetings will be held by the researcher in the health center in three consecutive weeks. In each session, the researcher encourages women to participate in the discussion through open-ended questions to express their information and experiences about weight gain during pregnancy. Then the researcher explains the necessary information in simple language. At the end of the sessions, a pamphlet titled "Role of spouses in physical and emotional support of pregnant mothers" is provided to women. From that time until the end of pregnancy, weekly motivational text messages for weight control are sent to women. It is also recommended that women write daily notes about their physical activity during pregnancy. The virtual group is formed to answer women's questions about weight control during pregnancy, and the benefits of weight control and the harms of obesity for the mother and fetus are repeatedly emphasized. Also, a pamphlet titled "Communication Skills Training in Dealing with Overweight Women" is provided to midwives in health care centers.
Category
N/A
2
Description
Control group: Pregnant women in the control group will receive prenatal care from health centers. Providing care in this group is routine and the researcher will not interfere in their pregnancy care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health centers affiliated to Jundishapur University of Medical Sciences, Ahvaz
Full name of responsible person
Nahid Javadi Far
Street address
Golestan Boulevard, Jundishapur University of Medical Sciences, Faculty of Nursing and Midwifery, Department of Midwifer
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8331
Email
nahidjavadifar_341@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakir Kish
Street address
Golestan Blvd., Research and Technology Development Vice-Chancellor of Jundishapur University of Medical Sciences, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nahid Javadi Far
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Golestan Blvd., Jundishapur University of Medical Sciences, Ahvaz, Faculty of Nursing and Midwifery, Department of Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8331
Fax
Email
nahidjavadifar_341@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
elahe banafshe
Position
Midwifery PhD student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan highway, next to Jundi Shapur University of Medical Sciences, Sisters dormitory complex
City
Ahvaz
Province
Khouzestan
Postal code
61358-15751
Phone
+98 61 3311 2652
Email
banafsheelahe@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
elahe banafshe
Position
Midwifery PhD student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan highway, next to Jundi Shapur University of Medical Sciences, Golestan sisters dormitory complex
City
Ahvaz
Province
Khouzestan
Postal code
61358-15751
Phone
+98 61 3311 2652
Email
banafsheelahe@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data can be published after the completion of the thesis
When the data will become available and for how long
One year after finishing the thesis
To whom data/document is available
Jundishapur University of Medical Sciences, Ahvaz
Under which criteria data/document could be used
After analysis, the data will be available to others through publication in scientific research journals.
From where data/document is obtainable
elahe banafshe,
banafsheelahe@gmail.com
What processes are involved for a request to access data/document
Information will be available through printing the article. But if the person wants more information, he can express his request through email.