NCT07465315

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
740

participants targeted

Target at P75+ for phase_2

Timeline
6mo left

Started May 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
May 2026Feb 2027

First Submitted

Initial submission to the registry

March 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

March 6, 2026

Last Update Submit

March 12, 2026

Conditions

Environmental Exposure

Keywords

Environmental ExposureBiological MonitoringBiomarkersUrineHairEnvironmental PollutantsHealthy Lifestyle

Outcome Measures

Primary Outcomes (1)

  • 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 (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

    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

Study Arms (2)

Current recommendations

ACTIVE COMPARATOR

Participants will receive healthy lifestyle guidelines from the public healthcare system, supported by short talks

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

Behavioral: INPOL healthy lifestyle informative guidelines

Interventions

Guidelines from the public healthcare systemBEHAVIORAL

Healthy lifestyle guidelines from the public healthcare system, supported by short talks

Current recommendations
INPOL healthy lifestyle informative guidelinesBEHAVIORAL

Informative guidelines focused on how to decrease environmental chemical pollutant exposure, supported by short talks and social network interaction.

INPOL recommendations

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Universitario Clínico San Cecilio

Granada, Granada, 18007, Spain

Location

Hospital Comarcal Santa Ana

Motril, Granada, 18600, Spain

Location

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Clínica de neurociencias Imbrain

Melilla, Melilla, 52001, Spain

Location

Central Study Contacts

Juan P Arrebola

CONTACT

958 24 96 18jparrebola@ugr.es

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 11, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Access Criteria
Under request

Locations

ES(5)