The effect of family-centered theory-based intervention to increase preventive behaviors iron deficiency anemia on the primary students in Torbat Heydariyeh City
The effect of theory-based family-based educational intervention on promoting mothers' preventive behaviors of maternal iron deficiency anemia
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 300 patients. PASS software was used for randomization.
Settings and conduct
The study population is the mothers of families living in Torbat-e Heydarieh. The researcher first studies valid scientific books and articles and collects the necessary information related to the research topic. According to the respected professors, the researcher of a preliminary study to examine the cognitive and behavioral status of mothers, will be performed on mothers in the city of Torbat Heydariyeh who represent the real community.
Participants/Inclusion and exclusion criteria
The condition for entering the participants' research is knowledge of the research objectives, satisfaction with participation, as well as having a first-year girl in primary school and an average age of 23 to 35 years.
Intervention groups
Educational intervention group: A group of mothers with the first daughter of the primary school is studied. An 8-member educational class is held in 9 different groups with group discussion and brainstorming to improve the intervention mapping approach.
Control group: There is a group of selected mothers from families living in Torbat-e Heydarieh city who are included in the study as mothers with first graders, but no educational intervention will be performed on them and as a control group to compare with the intervention group. , Will be examined.
Main outcome variables
The rate of improvement of iron deficiency anemia prevention behaviors of first grade female students in Torbat-e Heydarieh is determined and compared by mothers before and six months after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160824029512N2
Registration date:2022-04-05, 1401/01/16
Registration timing:registered_while_recruiting
Last update:2022-04-05, 1401/01/16
Update count:0
Registration date
2022-04-05, 1401/01/16
Registrant information
Name
mohammad hossien delshad
Name of organization / entity
Torbat Heydariyeh University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5222 1508
Email address
h.delshad@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-14, 1400/08/23
Expected recruitment end date
2022-04-12, 1401/01/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered theory-based intervention to increase preventive behaviors iron deficiency anemia on the primary students in Torbat Heydariyeh City
Public title
Family-centered educational intervention on iron deficiency anemia prevention behaviors
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Knowledge of research objectives, satisfaction with participation, having a first year girl in primary school, having 23 to 35 years of age in mothers
Exclusion criteria:
Dissatisfaction to participate in research
Incomplete completion of questionnaires
Age
From 23 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method and descriptions of each method: Layered randomization method with random assignment to intervention and control groups, followed by simple random sampling method with proportional assignment in each of the clusters of participants (mothers of first-year female students elementary School)
Randomization unit: Cluster
Randomization layers: First, all mothers of families with the first elementary school daughter of the study are classified among the invited participants in the study into subgroups with the same characteristics or characteristics, which are known as classes. From the classification groups, simple random sampling is performed, in which each element in the same subgroup is neutrally selected. During each stage of the sampling process, randomly and completely randomly.
Randomization tools: are selected with PASS statistical software randomization tools.
How to make a random sequence: To create a random sequence in the experiments of the two groups, one of the study groups is considered a lion and the other group is considered a line. They find it by accident.
Explanation of concealment: It is a double-blind randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Mothers with a first-year girl in primary school with an average age of 23 to 35 years because they are the booklet of the control group or the intervention is blinded and do not know and also the researcher does not know about the intervention and control group.
Placebo
Not used
Assignment
Parallel
Other design features
Data collection is done in the form of a questionnaire that was interviewed by the researcher from mothers. It is a theory-based planning framework that evaluates and intervenes in health-related issues through an ecological approach. Intervention mapping to make the necessary changes at different ecological levels focuses on how to change the behavior of people at risk and environmental factors to make behavioral changes that lead to changes in health and quality of life
Primary outcome: Percentage of behaviors to prevent anemia in first grade female students of Torbat-e Heydarieh by mothers ", score of blood iron level test of first-year primary school girls" and "Percentage of regular physical activity by first grade female students in Torbat-e Heydarieh" Be. Definition of the percentage of preventive behavior: Performing the predicted health behavior means performing a health task continuously and consecutively for at least 6 months, after which the person can perform the health task without any problems. Definition of Blood Iron Levels: The amount of iron in a person's serum or blood. Definition of physical activity: Any activity or movement of the body that is caused by the contraction and expansion of skeletal muscles and requires energy is called physical activity. The use of iron tablets during pregnancy in mothers means the complete use of iron tablets during pregnancy and also other consequences include attitude score, studying the attitude to the concept of a person's belief about the desirability or undesirable behaviors to prevent anemia in female students in the class It is the first to be assessed based on existing and related questions in the study tool. Awareness of preventive behaviors and mothers' behavior. The mothers' knowledge about preventive behaviors of students' anemia, which will be measured based on their answers to the relevant questions in the questionnaire.
Timepoint
Before, after and 6 months after intervention
Method of measurement
Self-reported questionnaire,Tools to prevent pediatric anemia behaviors according tointervention mapping protocol.
Secondary outcomes
empty
Intervention groups
1
Description
Educational intervention group: A group of mothers with the first daughter of the primary school is studied. An 8-member educational class is held in 9 different groups with group discussion and brainstorming to improve the intervention mapping approach.
Category
Behavior
2
Description
Control group: There is a group of selected mothers from families living in Torbat-e Heydarieh city who are included in the study as mothers with first graders, but no educational intervention will be performed on them and as a control group to compare with the intervention group. , Will be examined.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Torbate-Heidaria 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
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Mohammad Hossien Delshad
Position
Assistant
Latest degree
Specialist
Other areas of specialty/work
Health Promotion
Street address
North Ferdowsi Razi Razi 2, No. 14, 2nd floor
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9519633885
Phone
+98 51 5222 1508
Email
delshadmh1@thums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Mohammad hossien Delshad
Position
Assistant
Latest degree
Specialist
Other areas of specialty/work
Health Promotion
Street address
Ferdowsi St. Razi Razi St. 2, No. 14, 2nd Floor
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9519633885
Phone
+98 51 5222 1508
Fax
+98 51 5222 1508
Email
h.delshad@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Mohammad hossien Delshad
Position
Assistant
Latest degree
Specialist
Other areas of specialty/work
Health Promotion
Street address
Ferdowsi St. Razi Razi St. 2, No. 14, 2nd floor
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9519633885
Phone
+98 51 5222 1508
Fax
+98 51 5222 1508
Email
h.delshad@modares.ac.ir
Web page address
http://delshad264.blogfa.com/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
This section contains information that is not supported in the new version of IRCT. You need to edit this information and enter the existing content in the new version of the program. The content of the previous data is shown to you below. Please copy it and paste it in the appropriate place. Please make sure all previous content is transferred to the new structure. Please note that in future visits the previous content will be deleted and only the transferred content will be available on the site.
When the data will become available and for how long
This section contains information that is not supported in the new version of IRCT. You need to edit this information and enter the existing content in the new version of the program. The content of the previous data is shown to you below. Please copy it and paste it in the appropriate place. Please make sure all previous content is transferred to the new structure. Please note that in future visits the previous content will be deleted and only the transferred content will be available on the site.
To whom data/document is available
This section contains information that is not supported in the new version of IRCT. You need to edit this information and enter the existing content in the new version of the program. The content of the previous data is shown to you below. Please copy it and paste it in the appropriate place. Please make sure all previous content is transferred to the new structure. Please note that in future visits the previous content will be deleted and only the transferred content will be available on the site.
Under which criteria data/document could be used
This section contains information that is not supported in the new version of IRCT. You need to edit this information and enter the existing content in the new version of the program. The content of the previous data is shown to you below. Please copy it and paste it in the appropriate place. Please make sure all previous content is transferred to the new structure. Please note that in future visits the previous content will be deleted and only the transferred content will be available on the site.
From where data/document is obtainable
This section contains information that is not supported in the new version of IRCT. You need to edit this information and enter the existing content in the new version of the program. The content of the previous data is shown to you below. Please copy it and paste it in the appropriate place. Please make sure all previous content is transferred to the new structure. Please note that in future visits the previous content will be deleted and only the transferred content will be available on the site.
What processes are involved for a request to access data/document
This section contains information that is not supported in the new version of IRCT. You need to edit this information and enter the existing content in the new version of the program. The content of the previous data is shown to you below. Please copy it and paste it in the appropriate place. Please make sure all previous content is transferred to the new structure. Please note that in future visits the previous content will be deleted and only the transferred content will be available on the site.
Comments
This section contains information that is not supported in the new version of IRCT. You need to edit this information and enter the existing content in the new version of the program. The content of the previous data is shown to you below. Please copy it and paste it in the appropriate place. Please make sure all previous content is transferred to the new structure. Please note that in future visits the previous content will be deleted and only the transferred content will be available on the site.