Determining the effect of Consultation based on new technologies on changing the physical activity behavior of pregnant women
Design
Clinical trial with control group, randomized, simple randomized blocked method is used for randomization.
Settings and conduct
Forty people will be selected from the pregnant women who refer to the health centers of Urmia, taking into account the loss of the sample. Virtual space (creating a virtual channel and group) and using it at home is provided for the comfort of pregnant mothers.
Participants/Inclusion and exclusion criteria
Participation in study - minimum literacy - less than 20 weeks of pregnancy, no chronic diseases (diabetes, high blood pressure, kidney disease), no medical reasons to restrict the movement of mothers, having prenatal care, having a smartphone , Internet access and residents of Urmia; Occurrence of any special forms or diseases in the current pregnancy, frequent bleeding during the intervention, preterm labour, reduced fetal movements, leakage of amniotic fluid, diet for a specific disease and migration from Urmia.
Intervention groups
The control group will only receive routine care and will receive a contact number from the intervention group to send instructional messages. These interventions are providing effective exercises and physical activity during pregnancy in the form of videos and photos and educational texts aimed at weight gain in the appropriate range of pregnancy.
Main outcome variables
physical activity; Body Mass Index; weight
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151004024340N15
Registration date:2020-06-05, 1399/03/16
Registration timing:retrospective
Last update:2020-06-05, 1399/03/16
Update count:0
Registration date
2020-06-05, 1399/03/16
Registrant information
Name
Hamideh Mohaddesi
Name of organization / entity
Urmia University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4963
Email address
mohaddesi.h@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
2019-01-10, 1397/10/20
Actual recruitment end date
2019-12-01, 1398/09/10
Trial completion date
2020-02-17, 1398/11/28
Scientific title
The Effect of New Technology-Based Consultation on Physical Activity Behavior Modification of Pregnant Women
Public title
The Effect of New Technology-Based Consultation on Physical Activity Behavior Modification of Pregnant Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to Participation in study
At least literacy
Being under 20 weeks of gestational age
Without risk of chronic diseases (diabetes, hypertension, kidney disease)
No medical reasons for the restriction of movement during pregnancy
No Mental illness and hospitalization (according to the client)
No cerclage
Having prenatal care
The ability to use new technology
Having a smartphone
Internet access
Living in Urmia
Exclusion criteria:
Occurrence of any particular form or disease in the current pregnancy such as pre eclampsia, diabetes, anemia, having a high-risk pregnancy and cerclage surgery
repeated bleeding during the intervention
preterm labour
decreased fetal movements
amniotic fluid leakage
diet for a specific disease
emigrating from Urmia
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
71
Randomization (investigator's opinion)
Randomized
Randomization description
Urmia Health Centers will be classified into three levels 1, 2 and 3 based on economic and social conditions. Then, from each level, 2 centers are randomly selected from all the centers by lottery method. Pregnant women in selective centers by weight groups (normal, overweight, obese), in three groups, independently using randomly assigned allocation method, individuals will be in two groups of control and intervention (according to importance) Weight groups, this process will be performed three times). In this way, first the blocks with AAABBB composition and all possible modes from that list were assigned to each of the exclusive codes, and then according to the sample size of each group, the number of blocks required was selected using the lottery method. will be.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی ارومیه
Street address
Orjhans Street, Resalat Blvd, Urmia , Iran
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Approval date
2018-08-15, 1397/05/24
Ethics committee reference number
IR.UMSU.REC.1397.162
Health conditions studied
1
Description of health condition studied
Pattern of physical activity during pregnancy
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
physical activity behavior
Timepoint
Before the start of the intervention and the end of the intervention
Method of measurement
pregnancy physical activity questionnaire
Secondary outcomes
1
Description
Maternal weight
Timepoint
Before the start of the intervention and the end of the intervention
Method of measurement
scales
2
Description
Body Mass Index
Timepoint
Before the start of the intervention and the end of the intervention
Method of measurement
Scales and meters
Intervention groups
1
Description
Intervention group: Providing effective exercises and information about physical activity during pregnancy in the form of videos, photos and educational texts with the aim of changing the behavioral pattern of physical activity of mothers through cyberspace (creating a channel and virtual group) and using it at home for the comfort of pregnant mothers. The unique dietary are prepared by a nutritionist and provided to women. The content will be placed in a virtual group for 8 sessions and will be re-evaluated with the tools immediately after the mothers' intervention.
Category
Behavior
2
Description
Control group: There is no intervention by the research team and they only receive routine care along with a unique diet prepared by a nutritionist.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Urmia city
Full name of responsible person
Rasul Entezar mahdi
Street address
West Azerbaijan Province, Urmia, Daneshkadeh str
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
hmohaddesi.han@gmail.com
Web page address
https://phc.umsu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Orjhans Street, Resalat Blvd, Urmia , Iran
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3222 9059
Email
hmohaddesi.han@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Erfaneh Talebi
Position
midwifery BS student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Orjhans Street, Resalat Blvd, Urmia , Iran
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3222 9059
Email
erfaneh_talebi_1995@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Hamideh Mohaddesi
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Orjhans Street, Resalat Blvd, Urmia , Iran
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3222 9059
Email
hmohadesi.han@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Erfaneh Talebi
Position
midwifery B.Sc. student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Urmia University of Medical Sciences, nursing & midwifery Faculty
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3275 4963
Fax
Email
erfaneh_talebi_1995@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document