Behavioural Intervention to Decrease Exposure to Emerging Chemical Pollutants

NCT07465315 — Phase 2 / Phase 3, Not yet recruiting, 740 participants, Universidad de Granada

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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

RegistryNCT07465315, acronym INPOL
StatusNot yet recruiting
PhasePhase 2 / Phase 3
Study typeInterventional; randomized, parallel, masking: double, prevention
Enrollment740 (Estimated)
SponsorUniversidad de Granada (Other)
ConditionsEnvironmental Exposure
InterventionsGuidelines from the public healthcare system, INPOL healthy lifestyle informative guidelines (Behavioral)
Datesstart 2026-05-01 (estimated), primary completion 2026-12-01 (estimated), completion 2027-02-01 (estimated), first posted 2026-03-11, last updated 2026-03-16
Locations5 sites in Spain

Related Papers Related Patents Related Grants Related Experts
All trials for Environmental Exposure All trials of Guidelines from the public healthcare system All trials of INPOL healthy lifestyle informative guidelines

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Current recommendationsActive comparatorBehavioral: Guidelines from the public healthcare systemParticipants will receive healthy lifestyle guidelines from the public healthcare system, supported by short talks
INPOL recommendationsExperimentalBehavioral: 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
  • Guidelines from the public healthcare system (Behavioral): Healthy lifestyle guidelines from the public healthcare system, supported by short talks
  • INPOL healthy lifestyle informative guidelines (Behavioral): Informative guidelines focused on how to decrease environmental chemical pollutant exposure, supported by short talks and social network interaction.

+Outcome measures

Primary outcomes

  • Difference between groups in the average number of measured pollutants that decrease by at least 5% from baseline to the 3 month follow up [From baseline to 3 month follow-up]

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 [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]

+Eligibility

Sex: All, ages: 30 Years to 60 Years, accepts healthy volunteers

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

+Locations (5)

FacilityCityCountryStatus
Hospital Universitario Clínico San CecilioGranada, GranadaSpain
Hospital Comarcal Santa AnaMotril, GranadaSpain
Hospital Universitario de FuenlabradaFuenlabrada, MadridSpain
Hospital Universitario 12 de OctubreMadrid, MadridSpain
Clínica de neurociencias ImbrainMelilla, MelillaSpain