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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05746130
Other study ID # TDK-2023-6207
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 16, 2023
Est. completion date February 21, 2024

Study information

Verified date March 2024
Source Akdeniz University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It is known that Bisphenol-A (BPA) is the endocrine disrupting chemical that is most exposed by oral intake in daily life. Critical life periods when the sensitivity to these substances is known to be maximum; prenatal, postnatal and adolescence periods. The aim of this study is to compare the effects of plastic-free nutrition program, interactive education and BPA exposure feedback on urinary Bisphenol-A levels in adolescents with high use of packaged products.


Description:

By simple random sampling, female adolescents (n=36) staying in a high school hostel will be the intervention group, female adolescents not staying in hostels (n=36) will be the first comparison group, and female adolescents from another high school (n=36) will be the second comparison group. Plastic-free nutrition program (plastic-free diet, peer mentoring, interactive education and BPA exposure feedback) will be applied to the intervention group. Interactive training and BPA exposure feedback will be given to comparison group one, while only BPA exposure feedback will be given to comparison group two. Before and after the interventions, urinary BPA levels, use of plastic packaged products and bad nutrition attitudes of the adolescents will be monitored.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date February 21, 2024
Est. primary completion date June 9, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Plastic-free diet program
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.
Plastic-free diet education program
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
BPA exposure feedback
Feedback about BPA levels in theirs urinary sample

Locations

Country Name City State
Turkey Dösemealti Mesleki ve Teknik Anadolu Lisesi Antalya

Sponsors (1)

Lead Sponsor Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Urinary BPA level Urinary Bisphenol A Baseline-Second month
Secondary Plastic Packaged Product Usage 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
Secondary Attitude Towards Healthy Eating 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
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