determining the effect of planned program based on the theory of planned behavior on iron deficiency anemia of pregnant women
Design
This study is an intervention study of randomized clinical trial
After approving the proposal and obtaining a license from the Research Ethics Committee of Tarbiat Modares University, the researcher received a letter of introduction from the faculty and presented it to the relevant officials of the health network in the city. And by obtaining their consent, they will take a sample. The research population includes all pregnant women with iron deficiency anemia who refer to health centers in the city of Khoy in the province of West Azerbaijan. Sampling is clustered and random. Written consent is obtained from all research samples to participate in the study.
By referring to the centers, 200 pregnant women with iron deficiency anemia will be selected first by simple random sampling method. They are then assigned to the study group and control group for random allocation by 4-block block randomization. Using statistical methods, groups should be homogeneous in terms of demographic characteristics and pregnancy status.
Pregnant women who apply for maternity care will be considered as a sample if they have the entry and desire details to participate in the study and complete the written written consent form. Finally, the samples are randomly assigned to two intervention and control groups.
Settings and conduct
Khoy Health Centers, which includes 10 centers located in Khoy and is covered by Khoy University of Medical Sciences.
Participants/Inclusion and exclusion criteria
pregnant women
Intervention groups
The interventions will be designed as 4 training sessions, each lasting 45 to 55 minutes over 4 weeks.
control group will receive routin care.
Main outcome variables
Iron deficiency anemia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170218032635N1
Registration date:2020-04-24, 1399/02/05
Registration timing:retrospective
Last update:2020-04-24, 1399/02/05
Update count:0
Registration date
2020-04-24, 1399/02/05
Registrant information
Name
Afsaneh Sadooghiasl
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4875
Email address
asadooghi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of scheduled program based on the theory of planned behavior on the level of Iron deficiency anemia in pregnant women
Public title
scheduled program based on the theory of planned behavior on the level of Iron deficiency anemia in pregnant women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
3 to 6 months of pregnancy
Definite diagnosis of Iron deficiency anemia
Minimum literacy and ability to read and understand educational material
No evidence of chronic disease
Exclusion criteria:
Absolute illiteracy
Using antidepressants and Psychedelic medicine
problem in communicating
Lack of fluency in Persian
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization unit in this study is the Patient Referral Center, which is assigned to groups using a coin toss.
Blinding (investigator's opinion)
Double blinded
Blinding description
Neither participants nor data analyst know the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tarbiat Modares University
Street address
Chamran highway-Jalal al ahmed-
City
Teharn
Province
Tehran
Postal code
14115-331
Approval date
2019-05-07, 1398/02/17
Ethics committee reference number
IR.MODARES.REC.1398.031
Health conditions studied
1
Description of health condition studied
Iron Deficiency Anemia
ICD-10 code
D50.9
ICD-10 code description
Iron deficiency anemia, unspecified
Primary outcomes
1
Description
Iron deficiency Anemia
Timepoint
before intervention- 3 months later
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Interventions will be designed as 4 training sessions each for 45 to 55 minutes over 4 weeks. Behavioral goals will be determined for each training session and we will strive to achieve these goals using various methods such as lecture, instructional videos, Q&A, group discussion and individual counseling. Two sessions to raise awareness, one session to change the attitudes of pregnant women towards anemia prevention and treatment and their positive evaluation of iron deficiency diet, and a last session on behavioral control of pregnant women and their intention to choose the best method. Health care (iron pills or diet change) will take place.
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
Elnaz Zamanlu
Position
MSc student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Chamran highway.Jalal al ahmed
City
Tehran
Province
Tehran
Postal code
14115-331
Phone
+98 21 8288 4875
Fax
+98 21 8288 4875
Email
elnaz.zamanlu@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Afsaneh Sadooghiasl
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Chamran highway.Jalal al ahmed
City
Tehran
Province
Tehran
Postal code
14115-331
Phone
+98 21 8288 4875
Fax
+98 21 8288 4875
Email
a.sadooghi@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Afsaneh Sadooghiasl
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Chamran highway.Jalal al ahmed
City
Tehran
Province
Tehran
Postal code
14115-331
Phone
+98 21 8288 4875
Fax
+98 21 8288 4875
Email
a.sadooghi@modares.ac.ir
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The data will be released in groups without identification code.
When the data will become available and for how long
After the journal's decision to accept and publish the results in paper form is finalized
To whom data/document is available
Editors of scientific journals
Under which criteria data/document could be used
No new analysis of the data is permitted and can only be used to inform or verify the quality and scientific accuracy of the study
From where data/document is obtainable
Afsaneh Sadooghiasl
What processes are involved for a request to access data/document
After receiving a request from the editor in chief, a meeting will decide which piece of information they can publish and will be e-mailed or faxed after deleting any identifying code