跳至主要内容
临床试验/NCT05746130
NCT05746130已完成不适用

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

Akdeniz University1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2023年3月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
1
主要终点
Urinary BPA level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

plastic-free diet program

Experimental

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

干预措施: Plastic-free diet program (Behavioral)

plastic-free diet program

Experimental

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

干预措施: Plastic-free diet education program (Behavioral)

plastic-free diet program

Experimental

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

干预措施: BPA exposure feedback (Behavioral)

plastic free diet education program

Active Comparator

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

干预措施: Plastic-free diet education program (Behavioral)

plastic free diet education program

Active Comparator

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

干预措施: BPA exposure feedback (Behavioral)

BPA exposure feedback

Active Comparator

This group will take only BPA exposure feedback.

干预措施: BPA exposure feedback (Behavioral)

结局指标

主要结局

Urinary BPA level

时间窗: Baseline-Second month

Urinary Bisphenol A

次要结局

  • Attitude Towards Healthy Eating(Baseline-Second month)
  • Plastic Packaged Product Usage(Baseline-Second month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Ulusoy

PhD student

Akdeniz University

研究点 (1)

Loading locations...

相似试验

进行中(未招募)
不适用
Bisphenol-A release in orthodontic materials used to treat anterior open bite.Open bite
RBR-6t74w6gFaculdade de Odontologia da Universidade Federal de Minas Gerais
进行中(未招募)
1 期
A Study exploring the Biologic Effects and Biomarkers of Nivolumab in combination with Ipilimumab in Subjects with Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 20.1Level: LLTClassification code 10080083Term: Advanced lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Treatment-Naive Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 20.0Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2018-000462-11-ESBristol-Myers Squibb International Corporation250
进行中(未招募)
1 期
A Study exploring the Biologic Effects and Biomarkers of Nivolumab in combination with Ipilimumab in Subjects with Non-Small Cell Lung Cancer (NSCLC)Treatment-Naive Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1Level: LLTClassification code 10080083Term: Advanced lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2018-000462-11-BEBristol-Myers Squibb International Corporation250
进行中(未招募)
1 期
A Study exploring the Biologic Effects and Biomarkers of Nivolumab incombination with Ipilimumab in Subjects with Non-Small Cell Lung Cancer(NSCLC)Treatment-Naive Stage IV or recurrent Non-Small Cell Lung Cancer(NSCLC)MedDRA version: 20.0Level: LLTClassification code 10007096Term: Cancer of lungSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2018-000462-11-ITBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO250
进行中(未招募)
1 期
A Study exploring the Biologic Effects and Biomarkers of Nivolumab in combination with Ipilimumab in Subjects with Non-Small Cell Lung Cancer (NSCLC)Treatment-Naive Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1Level: LLTClassification code 10080083Term: Advanced lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2018-000462-11-ROBristol-Myers Squibb International Corporation250