Adolescent BehaviorNCT05746130
Effect of Preventive Education on Reducing Urinary Bisphenol-A Levels in Adolescents
A study testing Plastic-free diet program, Plastic-free diet education program and BPA exposure feedback in people with Adolescent Behavior and Bisphenol A, run by Akdeniz University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Bisphenol A, Urine
- What is being tested?
- Plastic-free diet program, Plastic-free diet education program and BPA exposure feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Mar 2023to 21 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Döşemealtı Mesleki ve Teknik Anadolu Lisesi
Antalya
About this study
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
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.
Read the 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.
- Conditions
- Adolescent Behavior, Bisphenol A, Urine
- Being tested
- Plastic-free diet program, Plastic-free diet education program, BPA exposure feedback
- Keywords
- Bisphenol A, urinary test, adolescent, Packaged Product Usage
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plastic-free diet programBehavioural
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 programBehavioural
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 feedbackBehavioural
Feedback about BPA levels in theirs urinary sample
| Study group | Role | What they receive |
|---|---|---|
| plastic-free diet program | Experimental | Plastic-free nutrition program will include plastic-free diet, peer mentoring, interactive education and BPA exposure feedback. Receives: Behavioral: Plastic-free diet program; Behavioral: Plastic-free diet education program; Behavioral: BPA exposure feedback |
| plastic free diet education program | Active comparator | This group will take peer mentoring, interactive education and BPA exposure feedback. Receives: Behavioral: Plastic-free diet education program; Behavioral: BPA exposure feedback |
| BPA exposure feedback | Active comparator | This group will take only BPA exposure feedback. Receives: Behavioral: BPA exposure feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary BPA level
Urinary Bisphenol A
Measured: Baseline-Second month
Secondary outcomes (2)
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.
Measured: Baseline-Second month
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.
Measured: Baseline-Second month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start16 Mar 2023
- Primary completion9 Jun 2023
- Study completion21 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Nonrandomised controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Ulusoy, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746130
- Sponsor's protocol ID
- TDK-2023-6207
- Status last verified
- Mar 2024
- First submitted
- 17 Feb 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05746130
- Acronym / sponsor ID
- TDK-2023-6207
- Conditions
- Adolescent Behavior, Bisphenol A, Urine
- Keywords
- Bisphenol A, urinary test, adolescent, Packaged Product Usage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Nonrandomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| plastic-free diet program | Experimental | Behavioral: Plastic-free diet program, Behavioral: Plastic-free diet education program, Behavioral: BPA exposure feedbackPlastic-free nutrition program will include plastic-free diet, peer mentoring, interactive education and BPA exposure feedback. |
| plastic free diet education program | Active comparator | Behavioral: Plastic-free diet education program, Behavioral: BPA exposure feedbackThis group will take peer mentoring, interactive education and BPA exposure feedback. |
| BPA exposure feedback | Active comparator | Behavioral: BPA exposure feedbackThis group will take only BPA exposure feedback. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plastic-free diet programApplying 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. | Behavioural | plastic-free diet program |
| Plastic-free diet education programInteractive 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 | Behavioural | plastic free diet education program, plastic-free diet program |
| BPA exposure feedbackFeedback about BPA levels in theirs urinary sample | Behavioural | BPA exposure feedback, plastic free diet education program, plastic-free diet program |
Primary outcome
Urinary BPA level
Time frame: Baseline-Second month
Urinary Bisphenol A
2 secondary outcomes
Plastic Packaged Product Usage
Time frame: Baseline-Second month
Attitude Towards Healthy Eating
Time frame: Baseline-Second month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plastic-free diet program, Plastic-free diet education program and BPA exposure feedback in people with Adolescent Behavior and Bisphenol A, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary BPA level (time frame: Baseline-Second month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.