Implementing an Adapted Smoke-free Homes Intervention in Spain

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).

NCT Number	NCT06932276
Lead Sponsor	Institut Català d'Oncologia Collaborators: Emory University, Public Health Agency of Barcelona, Agència de Salut Pública de Catalunya (ASPCAT)
Conditions	Secondhand Tobacco Smoke Exposure Reduction, Smoking Prevention
Enrollment	408 participants
Start Date	2024-04-02
Primary Completion	2027-01-30 (estimated)
Study Completion	2027-01-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-22