NCT05746130

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

March 16, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

February 17, 2023

Last Update Submit

March 4, 2024

Conditions

Adolescent BehaviorBisphenol AUrine

Keywords

Bisphenol Aurinary testadolescentPackaged Product Usage

Outcome Measures

Primary Outcomes (1)

  • Urinary BPA level

    Urinary Bisphenol A

    Baseline-Second month

Secondary Outcomes (2)

  • Plastic Packaged Product Usage

    Baseline-Second month

  • Attitude Towards Healthy Eating

    Baseline-Second month

Study Arms (3)

plastic-free diet program

EXPERIMENTAL

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

Behavioral: Plastic-free diet programBehavioral: Plastic-free diet education programBehavioral: BPA exposure feedback

plastic free diet education program

ACTIVE COMPARATOR

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

Behavioral: Plastic-free diet education programBehavioral: BPA exposure feedback

BPA exposure feedback

ACTIVE COMPARATOR

This group will take only BPA exposure feedback.

Behavioral: BPA exposure feedback

Interventions

Plastic-free diet programBEHAVIORAL

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 program
Plastic-free diet education programBEHAVIORAL

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 programplastic-free diet program
BPA exposure feedbackBEHAVIORAL

Feedback about BPA levels in theirs urinary sample

BPA exposure feedbackplastic free diet education programplastic-free diet program

Eligibility Criteria

Age14 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Döşemealtı Mesleki ve Teknik Anadolu Lisesi

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Nonrandomised controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

February 17, 2023

First Posted

February 27, 2023

Study Start

March 16, 2023

Primary Completion

June 9, 2023

Study Completion

February 21, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Locations

TU(1)