Effectiveness of a Behavioural Intervention to Decrease Exposure to Emerging Chemical Pollutants Compared to Standard Lifestyle Recommendations Among Adults in Spain (INPOL): a 3-month Multicentre, Parallel-group, Superiority Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 740
- 试验地点
- 5
- 主要终点
- Difference between groups in the average number of measured pollutants that decrease by at least 5% from baseline to the 3 month follow up
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of a behavioural intervention designed to reduce exposure to environmental chemical pollutants among adults in Spain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for the Screening phase:
- •Not planning to change residence within one year after recruitment
- •Spanish fluency
- •Living independently in the community
- •WhatsApp user
- •Age 30-60 years
- •Providing signed informed consent
排除标准
- •for the Screening phase:
- •Unable to provide any of the required biological samples
- •Suffering any chronic condition that substantially hinders adherence to the trial protocol and/or affects pollutant analyses
- •Inability to understand the informed consent, questionnaires, or intervention
- •Already participating in another intervention trial at the time of recruitment
- •Pregnancy or lactation
- •Inability to communicate with the research team and/or to attend the follow-up visits
- •Inclusion Criteria for the Intervention Phase:
- •Not planning to change residence within one year after recruitment
- •Spanish fluency
- •Living independently in the community
- •WhatsApp user
- •Age 30-60 years
- •Providing signed informed consent
- •Participant of the Screening phase
- •Exclusion Criteria for the Intervention Phase:
- •Unable to provide any of the required biological samples
- •Suffering from any chronic condition that substantially hinders adherence to the trial protocol and/or affects pollutant analyses
- •Inability to understand the informed consent, questionnaires, or intervention
- •Already participating in another intervention trial at the time of recruitment
- •Pregnancy or lactation
- •Inability to communicate with the research team and/or attend follow-up visits
研究组 & 干预措施
Current recommendations
Participants will receive healthy lifestyle guidelines from the public healthcare system, supported by short talks
干预措施: Guidelines from the public healthcare system (Behavioral)
INPOL recommendations
Participants will receive informative guidelines focused on how to decrease environmental chemical pollutant exposure, supported by short talks and social network interaction
干预措施: INPOL healthy lifestyle informative guidelines (Behavioral)
结局指标
主要结局
Difference between groups in the average number of measured pollutants that decrease by at least 5% from baseline to the 3 month follow up
时间窗: From baseline to 3 month follow-up
次要结局
- Difference between groups in the average number of measured chemicals that increase by at least 5% from baseline to 3 month follow-up between groups(Baseline to 3 month follow-up)
- Difference between groups in the average individual chemical concentrations at 3-month follow-up(Baseline to 3 month follow-up)
研究者
Juan Pedro Arrebola Moreno
Associate Professor
Universidad de Granada