The effect of a period of combined exercise training in overweight pregnant women on inflammatory factor ( TNF-α ) and Mean Arterial Pressure
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.TNF-a levels and blood pressure are 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, TNF-a and blood pressure are measured and MAP is calculated.The blood pressure is recorded in the last prenatal care of both groups.TNF-a 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
TNF-α, Mean Arterial Pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190410043222N1
Registration date:2019-05-02, 1398/02/12
Registration timing:registered_while_recruiting
Last update:2019-05-02, 1398/02/12
Update count:0
Registration date
2019-05-02, 1398/02/12
Registrant information
Name
Mona Pourmohammad Eilanjegh
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3857
Email address
mona_pou@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2020-04-20, 1399/02/01
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 inflammatory factor ( TNF-α ) and Mean Arterial Pressure
Public title
The effect of combined exercises in pregnancy and TNF-α levels and Mean Arterial Pressure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women in 11-16 weeks of gestation
Body Mass Index (BMI) of 25 -29.9 Kg / m2 before pregnancy or in the first prenatal visit
Mother's age 18-35 years old
Single pregnancy
Residing in Tehran
Iranian citizenship
Exclusion criteria:
Chronic and systemic diseases
Any of the absolute and relative contraindications of pregnancy exercises according to ACOG Guideline
Diabetes (type I, type II)
Use of psychological drugs, Opiate products or alcohol
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Participating mothers are randomly assigned into two groups (intervention and control) based on entry number in the study and using the random numbers table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Research Ethics Committee
Street address
Jalal Al-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2019-01-05, 1397/10/15
Ethics committee reference number
IR.MODARES.REC.1397.190
Health conditions studied
1
Description of health condition studied
Pregnancy
ICD-10 code
O13.9
ICD-10 code description
Gestational [pregnancy-induced] hypertension without significant proteinuria, unspecified trimester
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
Mona Pourmohammad Eilanjegh
Street address
Phase 3, Ekbatan complex , Sarem Hospital
City
Tehran
Province
Tehran
Postal code
1396956111
Phone
+98 21 4467 0888
Fax
Email
saremfertilityinfo@gmail.com
Web page address
http://saremfertility.com
2
Recruitment center
Name of recruitment center
Najmiyeh Hospital
Full name of responsible person
Mona Pourmohammad Eilanjegh
Street address
Jomhoori Ave. Hafez Crossroad
City
Tehran
Province
Tehran
Postal code
1139817813
Phone
+98 21 6670 7071
Email
najmiyeh@bagh.ac.ir
Web page address
https://najmiyeh.bmsu.ac.ir/Portal/Home/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Yaghoub Fathollahi
Street address
Jalal Al Ahamd 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 Moghaddam-Banaem
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.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Lida Moghaddam-Banaem
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.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mona Pourmohammad Eilanjegh
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Jalal Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 82883857
Email
mona_pou@modares.ac.ir
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
Data will be published in total not individual levels; because of the objectives of the study there is no need to publish individual characteristics and data of the participants
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
Outcomes of the study will be shared.
When the data will become available and for how long
6 months after results publication, data will be shared.
To whom data/document is available
All researchers who work in women health field can access this data.
Under which criteria data/document could be used
Data is applicable to use by all midwifery/ obstetrics personnel in cases of overweight pregnant women.
From where data/document is obtainable
Primary Investigator
What processes are involved for a request to access data/document