Environmental ExposurePhase 2/3INPOLNCT07465315
Behavioural Intervention to Decrease Exposure to Emerging Chemical Pollutants
A Phase 2/3 study testing Guidelines from the public healthcare system and INPOL healthy lifestyle informative guidelines in people with Environmental Exposure, run by Universidad de Granada at 5 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Environmental Exposure
- What is being tested?
- Guidelines from the public healthcare system and INPOL healthy lifestyle informative guidelines
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 740 participants
- Where
- 5 sitesSpain
- Study dates
- May 2026to Feb 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Spain5 sites
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942
Juan P Arrebola, +34 ext. 958 24 96 18, jparrebola@ugr.es
Hospital Universitario Clínico San Cecilio
Granada, Granada, 18007
Juan P Arrebola, 958 24 9618 ext. +34, jparrebola@ugr.es
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Juan P Arrebola, 958 24 96 18 ext. +34, jparrebola@ugr.es
Clínica de neurociencias Imbrain
Melilla, Melilla, 52001
Juan P Arrebola, 958 24 96 18 ext. +34, jparrebola@ugr.es
Hospital Comarcal Santa Ana
Motril, Granada, 18600
Juan P Arrebola, 958 24 96 18 ext. +34, jparrebola@ugr.es
About this study
Official title: 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.
- Conditions
- Environmental Exposure
- Being tested
- Guidelines from the public healthcare system, INPOL healthy lifestyle informative guidelines
- Keywords
- Environmental Exposure, Biological Monitoring, Biomarkers, Urine, Hair, Environmental Pollutants, Healthy Lifestyle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guidelines from the public healthcare systemBehavioural
Healthy lifestyle guidelines from the public healthcare system, supported by short talks
INPOL healthy lifestyle informative guidelinesBehavioural
Informative guidelines focused on how to decrease environmental chemical pollutant exposure, supported by short talks and social network interaction.
| Study group | Role | What they receive |
|---|---|---|
| Current recommendations | Active comparator | Participants will receive healthy lifestyle guidelines from the public healthcare system, supported by short talks Receives: Behavioral: Guidelines from the public healthcare system |
| INPOL recommendations | Experimental | Participants will receive informative guidelines focused on how to decrease environmental chemical pollutant exposure, supported by short talks and social network interaction Receives: Behavioral: INPOL healthy lifestyle informative guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between groups in the average number of measured pollutants that decrease by at least 5% from baseline to the 3 month follow up
Measured: From baseline to 3 month follow-up
Secondary outcomes (2)
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
Measured: Baseline to 3 month follow-up
Difference between groups in the average individual chemical concentrations at 3-month follow-up
Measured: Baseline to 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental ExposureStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 740 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Pedro Arrebola Moreno, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465315
- Sponsor's protocol ID
- PI23/01799
- Acronym
- INPOL
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07465315
- Acronym / sponsor ID
- INPOL / PI23/01799
- Conditions
- Environmental Exposure
- Keywords
- Environmental Exposure, Biological Monitoring, Biomarkers, Urine, Hair, Environmental Pollutants, Healthy Lifestyle
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 740 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 11 Mar 2026 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current recommendations | Active comparator | Behavioral: Guidelines from the public healthcare systemParticipants will receive healthy lifestyle guidelines from the public healthcare system, supported by short talks |
| INPOL recommendations | Experimental | Behavioral: INPOL healthy lifestyle informative guidelinesParticipants will receive informative guidelines focused on how to decrease environmental chemical pollutant exposure, supported by short talks and social network interaction |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Not planning to change residence within one year after recruitment
- Spanish fluency
- Living independently in the community
- WhatsApp user
- Age 30-60 years
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Guidelines from the public healthcare systemHealthy lifestyle guidelines from the public healthcare system, supported by short talks | Behavioural | Current recommendations |
| INPOL healthy lifestyle informative guidelinesInformative guidelines focused on how to decrease environmental chemical pollutant exposure, supported by short talks and social network interaction. | Behavioural | INPOL recommendations |
Primary outcome
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
2 secondary outcomes
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
Difference between groups in the average individual chemical concentrations at 3-month follow-up
Time frame: Baseline to 3 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Yes
Related trials for Environmental Exposure
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingObservational study
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Asthma
Recruiting
Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)
Cardiovascular Diseases (CVD), Metabolic Syndrome
Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
RecruitingObservational study
Natural History of the Human Biological Response to Environmental Exposure and Injury
Inflammation, Normal Controls
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Guidelines from the public healthcare system and INPOL healthy lifestyle informative guidelines in people with Environmental Exposure, run by Universidad de Granada at 5 sites in Spain.
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 13 inclusion and 12 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: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan P Arrebola (958 24 96 18 ext. 34, jparrebola@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 16 Mar 2026.