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Not yet recruiting NCT07465315

Behavioural Intervention to Decrease Exposure to Emerging Chemical Pollutants

Phase II / Phase III Interventional Environmental Exposure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Guidelines from the public healthcare system, INPOL healthy lifestyle informative guidelines.
Who it may be relevant to
Registry conditions: Environmental Exposure. Basic parameters: 30 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Behavioral Guidelines from the public healthcare system
    Healthy lifestyle guidelines from the public healthcare system, supported by short talks
  • Behavioral INPOL healthy lifestyle informative guidelines
    Informative guidelines focused on how to decrease environmental chemical pollutant exposure, supported by short talks and social network interaction.

Primary outcome measures

  • 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]
Secondary outcome measures (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 [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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Spain · 5 centers
  • Hospital Universitario Clínico San Cecilio — Granada
  • Hospital Comarcal Santa Ana — Motril
  • Hospital Universitario de Fuenlabrada — Fuenlabrada
  • Hospital Universitario 12 de Octubre — Madrid
  • Clínica de neurociencias Imbrain — Melilla

Identifiers

NCT: NCT07465315 · PI23/01799

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗