The purpose of the present study is to design and evaluate the effectiveness of an educational program regarding iodine intake and iodized salt on knowledge, attitude and practice levels and the iodine nutrition status of pregnant women. This survey is a semi experimental study (intervention-control) and single blind. 100 pregnant women, residents of southern Tehran, being the first trimester of pregnancy, referred to five health care centers will randomly select. Inclusion criteria will be pregnant women in the first trimester, without thyroid diseases and high blood pressure and willing to cooperate. Exclusion criteria will be having any thyroid diseases and hypertension during pregnancy and unwilling to cooperate. demographic characteristic and knowledge, attitude and practice status regarding the importance of iodine and iodized salt consumption will examine via two questionnaire and their iodine status will determine using urinary iodine concentration (UIC) and iodine content of salt in two steps at a distance of four months. intervention group will be received the education based on designed educational program in the second and third trimester.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201602035440N5
Registration date:2016-02-28, 1394/12/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-28, 1394/12/09
Registrant information
Name
Parisa Amiri
Name of organization / entity
Obesity research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 9309
Email address
amiri@endocrine.ac.ir
Recruitment status
Recruitment complete
Funding source
Research institute for endocrine sciences
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and evaluation of an educational package to provide of adequate iodine status during pregnancy
Public title
consumption of iodine during pregnancy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Being the first trimester of pregnancy, without thyroid diseases and high blood pressure, willing to cooperate.
Exclusion criteria: having any thyroid diseases and hypertension during pregnancy and unwilling to cooperate.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Participants will randomly allocated into the intervention or control groups (n = 50 each), using a random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
7th Floor , 2nd SBUMS Bldg. , Aarabi St., Yaman St., Next to Ayatollah Taleghani Hospital,Tehran, Iran.
City
Tehran
Postal code
198396-3113
Approval date
2014-06-10, 1393/03/20
Ethics committee reference number
715
Health conditions studied
1
Description of health condition studied
Iodine status
ICD-10 code
-
ICD-10 code description
Primary outcomes
1
Description
knowledge
Timepoint
before intervention and 4 months later
Method of measurement
questionnaire
2
Description
attitude
Timepoint
before intervention and 4 months later
Method of measurement
questionnaire
3
Description
practice
Timepoint
before intervention and 4 months later
Method of measurement
questionnaire
4
Description
urinary iodine concentration
Timepoint
before intervention and 4 months later
Method of measurement
acid digestion
5
Description
content of salt iodine
Timepoint
before intervention and 4 months later
Method of measurement
iodometric titration
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the educational program will last four months, and included two face to face educational sessions using a researcher-designed educational pamphlet in the second and the third trimesters; in addition, 2 follows-up by telephone calls will make between educational sessions. urinary iodine concentration (UIC) and salt iodine content will gather at baseline and 4 months after the intervention.
Category
Behavior
2
Description
control group: will receive the education usually via health workers provided in health care centers. urinary iodine concentration (UIC) and salt iodine content will gather at baseline and 4 months after the intervention.