- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05746130
Effect of Preventive Education on Reducing Urinary Bisphenol-A Levels in Adolescents
A Comparison of the Effects of a Plastic-Free Nutrition Program, Interactive Education, and Exposure Feedback on Bisphenol-A Levels in Adolescents With Packaged Product High Usage
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Antalya, Turkey
- Döşemealtı Mesleki ve Teknik Anadolu Lisesi
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Willingness to participate in the research Being in the 14-18 age group Being a female student High (61-80 points) or moderate-high (41-60 points) scores from the plastic packaged product use questionnaire (PAUKA) Having a smart mobile phone Absence of obesity, hypertension, diabetes mellitus, cardiovascular, asthma, thyroid and kidney dysfunction or disease Absence of any syndrome (Metabolic, Turner Rett and Down syndrome etc.) Absence of any medication used continuously Absence of any chronic disease reported by the physician in the student follow-up/examination report
Exclusion Criteria:
Leaving school and hostel Not giving a spot urine sample Not participating in the plastic-free diet program in the hostel for the last week.
Desire to leave the study Participation in trainings <50% Diagnosis of disease (diabetes mellitus, kidney disease, gluten or lactose intolerance, etc.) in which dietary habits were changed during the study.
Experiencing a mental or physical illness that will prevent the continuity of participation in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: plastic-free diet program
Plastic-free nutrition program will include plastic-free diet, peer mentoring, interactive education and BPA exposure feedback.
|
Feedback about BPA levels in theirs urinary sample
Applying the plastic-free diet as four meals (three main meals, one snack) in pension kitchen. Promoting of glass water bottle giving and daily use. Interactive education program: Slogan competition, school board preparation, short film shooting, school canteen visits and plastic-free nutrition day event with the adolescents for four weeks by the researcher. Peer education will doing by Adolescents with Packaged Product Low Usage Feedback about BPA levels in theirs urinary sample. Interactive education program: Slogan competition, school board preparation, short film shooting, school canteen visits and plastic-free nutrition day event with the adolescents for four weeks by the researcher. Peer education will doing by Adolescents with Packaged Product Low Usage Feedback about BPA levels in theirs urinary sample |
|
Active Comparator: plastic free diet education program
This group will take peer mentoring, interactive education and BPA exposure feedback.
|
Feedback about BPA levels in theirs urinary sample
Interactive education program: Slogan competition, school board preparation, short film shooting, school canteen visits and plastic-free nutrition day event with the adolescents for four weeks by the researcher. Peer education will doing by Adolescents with Packaged Product Low Usage Feedback about BPA levels in theirs urinary sample |
|
Active Comparator: BPA exposure feedback
This group will take only BPA exposure feedback.
|
Feedback about BPA levels in theirs urinary sample
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Urinary BPA level
Time Frame: Baseline-Second month
|
Urinary Bisphenol A
|
Baseline-Second month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plastic Packaged Product Usage
Time Frame: Baseline-Second month
|
0-20 points indicate the use of low plastic packaged products, 21-40 points indicate the use of medium plastic packaged products, 41-60 points indicate the use of medium-high plastic packaged products, and 61-80 points indicate the use of high plastic packaged products.
|
Baseline-Second month
|
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Attitude Towards Healthy Eating
Time Frame: Baseline-Second month
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11 points obtained from the scale are very low, 12-22 points low, 23-33 points medium, 34-44 points high, 45-55 points ideally high, indicating the attitude towards healthy and plastic-free nutrition.
|
Baseline-Second month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TDK-2023-6207
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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