Objective:
The aim of this study is to evaluate a Theory-based educational intervention to change air pollution preventive behaviors among pregnant women in Tehran.
Design: A controlled clinical trial
Setting: Prenatal care services in Tehran.
Participants and eligibility criteria: 104 women with singleton pregnancy, 18-35 years old, gestational age less than 36 weeks and pregnancy without any complication will classified into intervention and control groups, randomly.
Intervention: A Transtheoretical Model (TTM)-based educational program consisted of three components: one- session motivational interviewing, a pamphlet and daily Short Message Service (SMS). The intervention will be implemented for intervention group; after one-month, follow up the data will be gathered through standard questionnaires.
Main outcome variables: Constructs of TTM; the stages of change, self-efficacy and perceived benefits and barriers.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012091010804N1
Registration date:2012-10-25, 1391/08/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-25, 1391/08/04
Registrant information
Name
Marzieh Araban
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
تهران
Email address
m.araban@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tarbiat Modares University
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2012-11-27, 1391/09/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of a Theory- based educational intervention to change air pollution exposure behaviors among pregnant women
Public title
Evaluation of a Theory- based educational intervention to change air pollution exposure behaviors among pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Main inclusion criteria: singleton pregnancy؛ maternal age age between 18-35 years old؛ gestational age less than 36 weeks؛ uncomplicated pregnancy
Main exclusion criteria:complicated pregnancy (Preeclampsia؛ gestational hypertension؛ gestational diabetes؛ preterm labor؛ bleeding)
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
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 Tarbiat Modares University
Street address
South east Gisha bridge, Tarbiat Modares University, number 1 building
City
Tehran
Postal code
1411713116
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
5271065
Health conditions studied
1
Description of health condition studied
behavioral intervention for pregnant women
ICD-10 code
O94-O99, O
ICD-10 code description
Other obstetric conditions, not elsewhere classified, Maternal care related to the fetus and amniotic cavity and possible delivery problems
Primary outcomes
1
Description
TTM constructs( including: perceived benefits and barriers, stage of change and self-efficacy)
Timepoint
1 month
Method of measurement
questionnaire
Secondary outcomes
1
Description
none
Timepoint
none
Method of measurement
none
Intervention groups
1
Description
The intervention consisted of three components: one- session motivational interviewing, a pamphlet and daily Short Message Service (SMS).
Category
Behavior
2
Description
Control group will receive routine prenatal care.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Najmiyeh hospital
Full name of responsible person
Marzieh Araban
Street address
Hafez- Jomhouri cross section, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tarbiat Modares University
Full name of responsible person
Seddigheh sadat Tavafian
Street address
Number 1 building,Tarbiat Modares University, south east Gisha bridge,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tarbiat Modares University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Seddigheh sadat Tavafian
Position
Ph.D, Associate proffesor
Other areas of specialty/work
Street address
Number 1 building, Tarbiat Modares University, south east Gisha bridge
City
Tehran
Postal code
1411713116
Phone
+98 21 8288 4547
Fax
+98 21 8288 4555
Email
tavafian@modares.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Marzieh Araban
Position
Ph.D student in health education
Other areas of specialty/work
Street address
Number 1 building, Tarbiat Modares University, south east Gisha bridge
City
Tehran
Postal code
1411713116
Phone
00
Fax
+98 21 8288 4555
Email
araban62@gmail.com, m.araban@modares.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)