Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06932276

Implementing an Adapted Smoke-free Homes Intervention in Spain

Led by Institut Català d'Oncologia · Updated on 2025-06-04

408

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

Sponsors

I

Institut Català d'Oncologia

Lead Sponsor

E

Emory University

Collaborating Sponsor

AI-Summary

What this Trial Is About

While smoking and exposure to second-hand tobacco smoke (SHS) in most public places is addressed by smoke-free regulations, the exposure to SHS at private places, such as homes, is still prevalent in Spain and represents a significant public health challenge. Main objective of the study: to evaluate the effectiveness of an evidence-based intervention to create smoke-free homes in households with children. Design: cluster randomised controlled trial. Target population: families with children (≤18 years old) and at least one smoker who allow smoking in the home. Sample: 51 clusters per group (intervention and control) with an average 4 participants per cluster. In total, 102 schools and 408 participants. Recruitment: The Tobacco Control Unit, the study promoter, will invite the Associations of the Students' Families (ASF) of schools in the Metropolitan Area of Barcelona to join the study. Those ASFs that participate, will run an information campaign among their members (caregivers of students enrolled at each school) explaining them the study and providing a link to sign up for it via a designated Website. Tobacco Control Unit Research Team will then contact the potential participants and start their participation. The intervention is an adapted intervention "Some things a better outside" developed by the Emory University. The intervention is based on 5 steps (Decide; Talk; Pick a date; Make it happen; and Keep it up) and is delivered during 6 weeks in 2-week intervals (first mailing, counselling call, and two other mailings). The intervention will be delivered only to the IG participants in the CG will not receive the intervention but may optionally receive it following the 6 months follow-up. Data collection: 1) baseline; 2) at month 3 postbaseline; 3) at month 6 postbaseline. Primary outcome: prevalence of households with complete smoking ban in the homes at follow-ups (self-reported). Secondary outcomes: SHS exposure level at follow-ups (self-reported).

CONDITIONS

Official Title

Implementing an Adapted Smoke-free Homes Intervention in Spain

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older
  • Live in a household with at least one child younger than 18 years old
  • Live in a household with at least one person who smokes
  • Smoking is allowed at home at all times or sometimes, including balconies or terraces
  • Speak and understand Catalan or Spanish
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

Catalan Institute of Oncology

Barcelona, Catalonia, Spain, 08908

Actively Recruiting

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Research Team

O

Olena Tigova, MPH, PhD Candidate

CONTACT

C

Cristina Martínez, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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