Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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Place of study: Tehran city; Study population: housewives; Type of blinding: none
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2024-07-12, 1403/04/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-09-22, 1403/07/01
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Expected recruitment end date
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2024-11-21, 1403/09/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of educational intervention based on mobile application on the knowledge, attitude and practice of women about microplastics on health
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Public title
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The impact of education via mobile phone on knowledge, attitude, and practice regarding microplastics on health
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
136
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-06-22, 1403/04/02
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Ethics committee reference number
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IR.MODARES.REC.1403.041
Health conditions studied
1
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Description of health condition studied
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Microplastic effect
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ICD-10 code
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Y97
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ICD-10 code description
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Environmental-pollution-related condition
Primary outcomes
1
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Description
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The knowledge score in the researcher-made questionnaire about the effect of microplastics on health
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Timepoint
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Before the intervention, immediately, and two months after the intervention
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Method of measurement
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A researcher-made questionnaire about the effect of microplastics on health
2
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Description
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The attitude score in the researcher-made questionnaire about the effect of microplastics on health
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Timepoint
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Before the intervention, immediately, and two months after the intervention
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Method of measurement
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A researcher-made questionnaire about the effect of microplastics on health
3
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Description
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The practice score in the researcher-made questionnaire about the effect of microplastics on health
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Timepoint
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Before the intervention, immediately, and two months after the intervention
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Method of measurement
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A researcher-made questionnaire about the effect of microplastics on health
Intervention groups
1
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Description
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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.
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Category
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Behavior
2
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Description
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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.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tarbiat Modares University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Part of the data related to the main outcomes can be shared
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When the data will become available and for how long
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The access period starts 6 months after the results are published
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To whom data/document is available
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The data will be made available only to researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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Repeated measures analysis to investigate the effect of training persistence 6 months after the last intervention
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From where data/document is obtainable
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By sending an email to the email address of Dr. Fatemeh Zarei f.zarei@modares.ac.ir
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What processes are involved for a request to access data/document
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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.
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Comments
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