The effect of a period of combined exercise training in overweight pregnant women on ant inflammatory factor Interleukin10
Design
The sampling method is convenient, including overweight pregnant women at 11-16 w gestational visiting hospital prenatal care unit. . By using random digit table, participating mothers are randomly allocated to two study groups: intervention(exercise) group and control group.The sample size is 14 people for each group
Settings and conduct
A demographic/reproductive questionnaire is completed in person. Interleukin10 level is measured and recorded.Pregnant women are trained about exercises by training expert and researcher.The control group will continue their routine physical activity without especial plan. Besides checking the Gestational Diabetes screening at 24-28 w, Interleukin10 is measured. Interleukin10 level is measured and recorded at delivery time.
Participants/Inclusion and exclusion criteria
1-Pregnant women with 11-16 weeks of gestational age 2-Body Mass Index (BMI) of 25 -29.9 Kg / m2 before pregnancy or in the first prenatal visit
Intervention groups
The intervention protocol for intervention group includes: Aerobic exercise(walking) and stretching exercise(for muscle stretching). The exercise program will start from 16 w gestational and continue until 35 w gestational.To determine intensity,speaking test will be used. Control group during study period,will continue usual physical activity without specific training program
Main outcome variables
Interlukin10
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200415047084N1
Registration date:2021-03-23, 1400/01/03
Registration timing:retrospective
Last update:2021-03-23, 1400/01/03
Update count:0
Registration date
2021-03-23, 1400/01/03
Registrant information
Name
Nahid Zendehbil
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 28 3524 9212
Email address
nahidzendehbil@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-30, 1399/04/10
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a period of combined exercise training in overweight pregnant women on level ant inflammatory factor interlukin10
Public title
The effect of a period of combined exercise training in overweight pregnant women on level ant inflammatory factor interlukin10
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian citizenship
Pregnant women with 11-16 weeks of gestational age
Mother's age 18-35 years old
Residing in Tehran
Body Mass Index (BMI) of 25 -29.9 Kg / m2 before pregnancy or in the first prenatal visit
Single pregnancy
Exclusion criteria:
Chronic and systemic diseases
Diabetes (type I, type II)
Use of psychological drugs،Opiate products or alcohol
Any of the absolute and relative contraindications of pregnancy exercises according to ACOG Guideline
Week 16-11 of pregnancy, Week 28-24 of pregnancy and delivery time
Method of measurement
Venous blood sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group, after training exercise , begin a Specific combined exercise schedule including aerobic, resistance and endurance activities from the 16 weeks of gestational age.The combination of exercises will be based on the gestational age. At each prenatal visit, the exercise program for 4 weeks later will be given to pregnant women. weekly How to do exercises, will be controlled by researcher trough phone call . Exercises will be continued until 35 weeks of gestational age. Routine prenatal care visits will be done during pregnancy. Pregnant women whenever they want, they can be removed from the intervention group. If any of the interventions group exits, a new sample will be replaced.
Category
Prevention
2
Description
The Control group :This group will be had usual physical activity during pregnancy. Routine prenatal care visits will be done during pregnancy. Pregnant women whenever they want, they can be removed from the control group. If any of the control group exits, a new sample will be replaced.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sarem Hospital
Full name of responsible person
Nahid zendehbil
Street address
Ekbatan town, Sarem specialized and subspecialty hospital
City
Tehran
Province
Tehran
Postal code
1396956111
Phone
+98 21 4467 0888
Email
saremfertilityinfo@gmail.com
Web page address
http://saremfertility.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Yaqub Fath Elahi
Street address
Jalal Al-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3857
Email
moghaddamb@modares.ac.ir
Web page address
http://www.modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Lida mogaddam bnaem
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Jalal Al-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3857
Email
moghaddamb@modares.ac.ir
Web page address
http://www.modares
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Lida mogadam bnaem
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Jalal Al-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 82883857
Email
moghaddamb@modares.ac.ir
Web page address
http://www.modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Nahid zendehbil
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Jalal Al-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 82883857
Email
Nahidzendehbil@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The data will be reported collectively because there is no need to publish participants' personal characteristics and data according to the study objectives.
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
No - There is not 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
Information about the consequences will be shared.
When the data will become available and for how long
Information will be shared 6 months after the results are published.
To whom data/document is available
All researchers working in the field of women's health can access this information
Under which criteria data/document could be used
For midwives and midwives, it can be used by overweight pregnant women
From where data/document is obtainable
The main researcher of the project
What processes are involved for a request to access data/document
Email containing the request for the original project researcher