Implementing an Adapted Smoke-free Homes Intervention in Spain

NCT06932276 | Recruiting DMC

• 2 other identifiers: SHF-SpainPI21/00818
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

Brief Summary

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

Secondhand Tobacco Smoke Exposure Reduction; Smoking Prevention

Keywords

smoke-free homes; Spain

Outcome Measures

Primary Outcomes (1)

• Complete smoke-free rule at home

  At recruitment, none of the participants will have a smoke-free home. The primary outcome measure of this study is the number of participants who establish a smoke-free home, meaning those who report that the current home smoking rule is not to smoke anywhere indoors or outdoors (balconies) the home. This will be assessed through a telephone survey using the question: "Which statement best describes the smoking rules in your home?", with response options: 1) Smoking is never allowed in any part of the home, including indoor and outdoor areas such as a balcony or terrace. 2) Smoking is allowed only sometimes or in specific areas within the home. 3) Smoking is allowed anywhere and at any time in the home, meaning there are no smoking restrictions. Participants who select response number one will be considered to have a smoke-free home.

  3 and 6 months post-baseline

Secondary Outcomes (5)

• Home smoking frequency

  3 and 6 months post-baseline

• Second-hand smoke exposure at home

  Past 7 days; 3 and 6 months post-baseline

• Complete smoke-free vehicle rule

  3 and 6 months post-baseline

• Among participants who smoke: Cigarette consumption

  Past 7 days; assessed at 3 and 6 months post-baseline

• Among participants who smoke: Cessation attempts

  Past 3 months; assessed at 3 and 6 months post-baseline

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive an adapted version of the "Some Things Are Better Outside" intervention, designed to encourage them to voluntarily create a smoke-free home by accepting a norm of never smoking at home, whether indoors or outdoors, such as on balconies. The intervention is delivered over six weeks and consists of four components: an initial mailing of printed materials, a coaching call, and two additional mailings. It is based on five steps to adopting a smoke-free home: 1) deciding on the reasons for creating one, 2) discussing it with family members, 3) choosing a date to go smoke-free, 4) making the home a smoke-free environment, and 5) maintaining it as smoke-free.

Behavioral: "Some things a re better outside"

Control

NO INTERVENTION

Participants in the intervention group will not receive the intervention. However, all participants in the control group will be offered the intervention after the final follow-up, which takes place six months post-baseline.

Interventions

"Some things a re better outside" BEHAVIORAL

"Some Things Are Better Outside" interventionis designed to encourage participants to voluntarily create a smoke-free home by accepting a norm of never smoking at home, whether indoors or outdoors, such as on balconies. The intervention is delivered over six weeks and consists of four components: an initial mailing of printed materials, a coaching call, and two additional mailings. It is based on five steps to adopting a smoke-free home: 1) deciding on the reasons for creating one, 2) discussing it with family members, 3) choosing a date to go smoke-free, 4) making the home a smoke-free environment, and 5) maintaining it as smoke-free.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18 years or older)
• Live in a household with at least one minor (younger than 18 years old)
• Live in a household with at least one person who smokes
• Smoking is allowed at home (always or sometimes; everywhere or in some specific places, including balconies or terraces).
• Speak and understand Catalan or Spanish.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Institut Català d'Oncologia: lead
• Emory University: collaborator
• Public Health Agency of Barcelona: collaborator
• Agència de Salut Pública de Catalunya (ASPCAT): collaborator

Study Sites (1)

Catalan Institute of Oncology

Barcelona, Catalonia, 08908, Spain

RECRUITING

Study Officials

• Esteve Fernández, MD, PhD

  Catalan Insititute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olena Tigova, MPH, PhD Candidate

CONTACT

0034932607345; otigova@iconcologia.net

Cristina Martínez, PhD

CONTACT

0034932607335; cmartinez@iconcologia.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized trial: randomization at level of Assotiation of Students Families (ASF, i.e. school). All participants from the same ASF will be either in the intervention or a control group.

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 17, 2025
• Study Start: April 2, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)