- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07465315
Behavioural Intervention to Decrease Exposure to Emerging Chemical Pollutants (INPOL)
March 12, 2026 updated by: Juan Pedro Arrebola Moreno, Universidad de Granada
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
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.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
740
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Juan P Arrebola
- Phone Number: 34 958 24 96 18
- Email: jparrebola@ugr.es
Study Locations
-
-
Granada
-
Granada, Granada, Spain, 18007
- Hospital Universitario Clínico San Cecilio
-
Contact:
- Juan P Arrebola
- Phone Number: +34 958 24 9618
- Email: jparrebola@ugr.es
-
Motril, Granada, Spain, 18600
- Hospital Comarcal Santa Ana
-
Contact:
- Juan P Arrebola
- Phone Number: +34 958 24 96 18
- Email: jparrebola@ugr.es
-
-
Madrid
-
Fuenlabrada, Madrid, Spain, 28942
- Hospital Universitario de Fuenlabrada
-
Contact:
- Juan P Arrebola
- Phone Number: 958 24 96 18 +34
- Email: jparrebola@ugr.es
-
Madrid, Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre
-
Contact:
- Juan P Arrebola
- Phone Number: +34 958 24 96 18
- Email: jparrebola@ugr.es
-
-
Melilla
-
Melilla, Melilla, Spain, 52001
- Clínica de neurociencias Imbrain
-
Contact:
- Juan P Arrebola
- Phone Number: +34 958 24 96 18
- Email: jparrebola@ugr.es
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria 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
Exclusion Criteria 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Current recommendations
Participants will receive healthy lifestyle guidelines from the public healthcare system, supported by short talks
|
Healthy lifestyle guidelines from the public healthcare system, supported by short talks
|
|
Experimental: INPOL recommendations
Participants will receive informative guidelines focused on how to decrease environmental chemical pollutant exposure, supported by short talks and social network interaction
|
Informative guidelines focused on how to decrease environmental chemical pollutant exposure, supported by short talks and social network interaction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Difference between groups in the average number of measured pollutants that decrease by at least 5% from baseline to the 3 month follow up
Time Frame: From baseline to 3 month follow-up
|
From baseline to 3 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
Time Frame: Baseline to 3 month follow-up
|
Baseline to 3 month follow-up
|
|
Difference between groups in the average individual chemical concentrations at 3-month follow-up
Time Frame: Baseline to 3 month follow-up
|
Baseline to 3 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
February 1, 2027
Study Registration Dates
First Submitted
March 6, 2026
First Submitted That Met QC Criteria
March 6, 2026
First Posted (Actual)
March 11, 2026
Study Record Updates
Last Update Posted (Actual)
March 16, 2026
Last Update Submitted That Met QC Criteria
March 12, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PI23/01799
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Access Criteria
Under request
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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