Effect of Preventive Education on Reducing Urinary Bisphenol-A Levels in Adolescents

Sponsor
Akdeniz University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05746130
Collaborator
(none)
108
3
3.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Plastic-free nutrition program
  • Behavioral: Interactive education
  • Behavioral: BPA exposure feedback
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Nonrandomised controlled trialNonrandomised controlled trial
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
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
Anticipated Study Start Date :
Mar 6, 2023
Anticipated Primary Completion Date :
May 6, 2023
Anticipated Study Completion Date :
Jun 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: plastic-free nutrition program

Plastic-free nutrition program will include plastic-free diet, peer mentoring, interactive education and BPA exposure feedback.

Behavioral: Plastic-free nutrition 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.

Behavioral: Interactive education
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

Behavioral: BPA exposure feedback
Feedback about BPA levels in theirs urinary sample

Active Comparator: Interactive education group

This group will take peer mentoring, interactive education and BPA exposure feedback.

Behavioral: Interactive education
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

Behavioral: BPA exposure feedback
Feedback about BPA levels in theirs urinary sample

Active Comparator: BPA feedback group

This group will take only BPA exposure feedback.

Behavioral: BPA exposure feedback
Feedback about BPA levels in theirs urinary sample

Outcome Measures

Primary Outcome Measures

  1. Urinary BPA [Baseline-Second month]

    Urinary Bisphenol A

Secondary Outcome Measures

  1. Plastic Packaged Product Usage [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.

  2. Attitude Towards Healthy Eating [Baseline-Second month]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 18 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Akdeniz University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fatma Ulusoy, PhDc, Akdeniz University
ClinicalTrials.gov Identifier:
NCT05746130
Other Study ID Numbers:
  • TDK-2023-6207
First Posted:
Feb 27, 2023
Last Update Posted:
Feb 27, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fatma Ulusoy, PhDc, Akdeniz University

Study Results

No Results Posted as of Feb 27, 2023