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General information
50
empty
50
Year
empty
year
No
Yes
1
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Based on the field survey and the potential constraints in reaching our target audience of housewives aged 18 to 50, we have decided to limit participation to women aged 18 and above, without any job restrictions. As a result, the entry criteria have been adjusted to exclude women outside the 18-50 age range and the reference to housewives.
Based on the field survey and the potential constraints in reaching our target audience of housewives aged 18 to 50, we have decided to limit participation to women aged 18 and above, without any job restrictions. As a result, the entry criteria have been adjusted to exclude women outside the 18-50 age range and the reference to housewives.
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با توجه به بررسی میدانی و احتمال کاهش دسترسی به گروه هدف زنان خانه دار محدود به بازه سنی 18 تا 50 سال تصمیم بر آن شد تا تنها مشارکت کنندگان به زنان 18 سال به بالا ختم شود و حدودیت شغلی تعیین نشود . لذا در معیار های ورود ایتم زنان سن ۱۸ -۱۵۰ سال و خانه دار حذف شد .
با توجه به بررسی میدانی و احتمال کاهش دسترسی به گروه هدف زنان خانه دار محدود به بازه سنی 18 تا 50 سال تصمیم بر آن شد تا تنها مشارکت کنندگان به زنان 18 سال به بالا ختم شود و حدودیت شغلی تعیین نشود . لذا در معیار های ورود ایتم زنان سن ۱۸ -۱۵۰ سال و خانه دار حذف شد .
Age 18 to 50 years
Being literate in reading and writing
Access to Android smart phone and internet
Willingness to participate in research
Ability to understand and answer the questionnaire
A resident of Tehran
Not receiving planned training about microplastics in advance
Housewife
Being literate in reading and writing
Access to Android smart phone and internet
Willingness to participate in research
Ability to understand and answer the questionnaire
A resident of Tehran
Not receiving planned training about microplastics in advance
Age 18 to 50 years Being literate in reading and writing Access to Android smart phone and internet Willingness to participate in research Ability to understand and answer the questionnaire A resident of Tehran Not receiving planned training about microplastics in advance Housewife
سن 18 تا 50 سال
داشتن سواد خواندن و نوشتن
دسترسی به تلفن همراه هوشمند اندروید و اینترنت
تمایل به شرکت در پژوهش
توانایی درک و پاسخ به پرسشنامه
ساکن تهران
عدم دریافت آموزش برنامه ریزی شده درباره میکروپلاستیک از قبل
خانه دار
داشتن سواد خواندن و نوشتن
دسترسی به تلفن همراه هوشمند اندروید و اینترنت
تمایل به شرکت در پژوهش
توانایی درک و پاسخ به پرسشنامه
ساکن تهران
عدم دریافت آموزش برنامه ریزی شده درباره میکروپلاستیک از قبل
سن 18 تا 50 سال داشتن سواد خواندن و نوشتن دسترسی به تلفن همراه هوشمند اندروید و اینترنت تمایل به شرکت در پژوهش توانایی درک و پاسخ به پرسشنامه ساکن تهران عدم دریافت آموزش برنامه ریزی شده درباره میکروپلاستیک از قبل خانه دار
Recruitment centers
#1
Name of recruitment center - English: Faculty of Medical Sciences
Name of recruitment center - Persian: دانشکده علوم پزشکی
Full name of responsible person - English: Zahra Seifi
Full name of responsible person - Persian: زهرا سیفی
Street address - English: Faculty of Medical Sciences, Tarbiat Modares University, Jalal Al Ahmad Highway, Tehran
Street address - Persian: تهران-جلال آل احمد، نصر، دانشگاه تربیت مدرس ، دانشکده علوم پزشکی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 14115111
Phone: +98 21 8288 4546
Fax:
Email: z_seifi@modares.ac.ir
Web page address:
Name of recruitment center - English: Faculty of Medical Sciences
Name of recruitment center - Persian: دانشکده علوم پزشکی
Full name of responsible person - English: Zahra Seifi
Full name of responsible person - Persian: زهرا سیفی
Street address - English: Faculty of Medical Sciences, Tarbiat Modares University, Nasr street, Jalal Al Ahmad highway
Street address - Persian: بزرگراه جلال آل احمد، خیابان نصر، دانشگاه تربیت مدرس، دانشکده علوم پزشکی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 14115111
Phone: +98 21 8288 4546
Fax:
Email: z_seifi@modares.ac.ir
Web page address:
Name of recruitment center - English: Faculty of Medical Sciences Name of recruitment center - Persian: دانشکده علوم پزشکی Full name of responsible person - English: Zahra Seifi Full name of responsible person - Persian: زهرا سیفی Street address - English: Faculty of Medical Sciences, Tarbiat Modares University, Nasr street, Jalal Al Ahmad Highway, Tehranhighway Street address - Persian: تهران-بزرگراه جلال آل احمد، خیابان نصر، دانشگاه تربیت مدرس، دانشکده علوم پزشکی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 14115111 Phone: +98 21 8288 4546 Fax: Email: z_seifi@modares.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Tarbiat Modares University
Name of organization / entity - Persian: دانشگاه تربیت مدرس
Full name of responsible person - English: Amir Abdulzadeh
Full name of responsible person - Persian: امیر عبدالله زاده
Street address - English: Faculty of Medical Sciences, Tarbiat Modares University, Jalal Al Ahmad Highway, Tehran
Street address - Persian: خیابان جلال آل احمد ، پل نصر ، دانشگاه تربیت مدرس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 141173116
Phone: +98 21 8288 4546
Fax:
Email: zadeh@modares.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tarbiat Modares University
Name of organization / entity - Persian: دانشگاه تربیت مدرس
Full name of responsible person - English: Amir Abdulzadeh
Full name of responsible person - Persian: امیر عبدالله زاده
Street address - English: Faculty of Medical Sciences, Tarbiat Modares University, Nasr street, Jalal Al Ahmad highway
Street address - Persian: بزرگراه جلال آل احمد، خیابان نصر، دانشگاه تربیت مدرس، دانشکده علوم پزشکی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 141173116
Phone: +98 21 8288 4546
Fax:
Email: zadeh@modares.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tarbiat Modares University Name of organization / entity - Persian: دانشگاه تربیت مدرس Full name of responsible person - English: Amir Abdulzadeh Full name of responsible person - Persian: امیر عبدالله زاده Street address - English: Faculty of Medical Sciences, Tarbiat Modares University, Nasr street, Jalal Al Ahmad Highway, Tehranhighway Street address - Persian: خیابانبزرگراه جلال آل احمد، پلخیابان نصر، دانشگاه تربیت مدرس، دانشکده علوم پزشکی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 141173116 Phone: +98 21 8288 4546 Fax: Email: zadeh@modares.ac.ir Web page address:
Protocol summary
Study aim
To evaluate the effect of an interventional education via mobile phone application on the Knowledge, Attitude, and Practice of women regarding the health effects of Microplastic
Design
This is an unblinded, randomized clinical trial with an intervention group and a control group with 136 eligible women. R software will be used for randomization. The envelope method will be used to conceal allocation.
Settings and conduct
Place of study: Tehran city; Study population: housewives; Type of blinding: none
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 50 years;
being literate in reading and writing;
access to an Android smartphone and the Internet;
Willingness to participate in research, ability to understand and answer the questionnaire;
a resident of Tehran;
Failure to receive planned training about microplastics in advance; being a housewife.
Exclusion criterion:
Participating in a parallel training program
Intervention groups
Intervention group: the implementation of the educational content based on the pre-test and review of the compiled texts will be provided to the intervention group in the form of a mobile phone application. Control group: during the educational study, they will not receive any intervention. The educational content will be available to them after the intervention is completed.
Main outcome variables
The mean score of women's knowledge about the effects of microplastics on health;
The mean score of women's attitudes about the effects of microplastics on health;
The mean score of women's practice about the effects of microplastics on health.
General information
Reason for update
Based on the field survey and the potential constraints in reaching our target audience of housewives aged 18 to 50, we have decided to limit participation to women aged 18 and above, without any job restrictions. As a result, the entry criteria have been adjusted to exclude women outside the 18-50 age range and the reference to housewives.
Acronym
IRCT registration information
IRCT registration number:IRCT20240529061941N1
Registration date:2024-07-12, 1403/04/22
Registration timing:prospective
Last update:2024-07-14, 1403/04/24
Update count:1
Registration date
2024-07-12, 1403/04/22
Registrant information
Name
Fatemeh Zarei
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4546
Email address
f.zarei@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention based on mobile application on the knowledge, attitude and practice of women about microplastics on health
Public title
The impact of education via mobile phone on knowledge, attitude, and practice regarding microplastics on health
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being literate in reading and writing
Access to Android smart phone and internet
Willingness to participate in research
Ability to understand and answer the questionnaire
A resident of Tehran
Not receiving planned training about microplastics in advance
Exclusion criteria:
Participating in a parallel training program
Having an IOS mobile phone
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
136
Randomization (investigator's opinion)
Randomized
Randomization description
Once the list of eligible individuals is prepared and numbered consecutively, the random allocation of the 136 participants to two groups, A and B will be achieved using the method of permutation blocks and a randomization list generated by a computer (R software using a binomial distribution). Following simple randomization procedures, participants will be assigned to one of the two arms of the trial in a 1:1 ratio according to a computer-generated randomization schedule via https://www.sealedenvelope.com/simple-randomiser/v1/lists. The letter A will be considered for the intervention group, the letter B will be considered for the control group. To maintain the integrity of the study, the allocation sequence will remain hidden from the participants and researchers involved in the trial.
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
Faculty of Medical Sciences, Tarbiat Modares University, Nasr street, Jalal Al Ahmad highway
City
Tehran
Province
Tehran
Postal code
111-14115
Approval date
2024-06-22, 1403/04/02
Ethics committee reference number
IR.MODARES.REC.1403.041
Health conditions studied
1
Description of health condition studied
Microplastic effect
ICD-10 code
Y97
ICD-10 code description
Environmental-pollution-related condition
Primary outcomes
1
Description
The knowledge score in the researcher-made questionnaire about the effect of microplastics on health
Timepoint
Before the intervention, immediately, and two months after the intervention
Method of measurement
A researcher-made questionnaire about the effect of microplastics on health
2
Description
The attitude score in the researcher-made questionnaire about the effect of microplastics on health
Timepoint
Before the intervention, immediately, and two months after the intervention
Method of measurement
A researcher-made questionnaire about the effect of microplastics on health
3
Description
The practice score in the researcher-made questionnaire about the effect of microplastics on health
Timepoint
Before the intervention, immediately, and two months after the intervention
Method of measurement
A researcher-made questionnaire about the effect of microplastics on health
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention will be designed in such a way that the participants will first be members of one of the most common social networks. After greeting them and introducing himself, the researcher will remind them of the objectives of the research, the research team, and the schedule for completing the questionnaire. Then he will send them the link to the mobile application for installation. After 4 weeks from the start of the training, the post-test process will be done immediately and two months later. The measurement and evaluation tools will be the same in all phases before and after the intervention. The educational intervention content will be delivered to the participants over four weeks through a mobile phone application designed specifically for this purpose. The app targets to qualify housewives, aiming to educate them on three key areas - the impact of microplastics, common beliefs and attitudes towards microplastics, and strategies for managing the use of plastics. The training materials will include videos, text, and motion graphics within the app.
Category
Behavior
2
Description
Control group: The control group will not receive the educational program, and at the end of the educational intervention, the control group will also receive the desired intervention based on ethical principles by receiving the link to install the application.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Medical Sciences
Full name of responsible person
Zahra Seifi
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Nasr street, Jalal Al Ahmad highway
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 4546
Email
z_seifi@modares.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Amir Abdulzadeh
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Nasr street, Jalal Al Ahmad highway
City
Tehran
Province
Tehran
Postal code
141173116
Phone
+98 21 8288 4546
Email
zadeh@modares.ac.ir
Grant name
Grant code / Reference number
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
Fatemeh Zarei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Nasr street, Jalal Al Ahmad highway
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 4546
Email
f.zarei@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fatemeh Zarei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Nasr street, Jalal Al Ahmad highway
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 4546
Email
f.zarei@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Ftemeh Zarei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Nasr street, Jalal Al Ahmad highway
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 4546
Email
f.zarei@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data related to the main outcomes can be shared
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be made available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Repeated measures analysis to investigate the effect of training persistence 6 months after the last intervention
From where data/document is obtainable
By sending an email to the email address of Dr. Fatemeh Zarei f.zarei@modares.ac.ir
What processes are involved for a request to access data/document
One week after sending the email from the requester to the email address of Dr. Fatemeh Zarei f.zarei@modares.ac.ir, a reply will be given.