Implementing an Adapted Smoke-free Homes Intervention in Spain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Català d'Oncologia
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
N/A
Trial design
Design model
Parallel
Treatments tested in this trial
"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.
Treatment groups
408 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
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.
Time frame
3 and 6 months post-baselineSecondary outcomes
1
Home smoking frequency
Self-reported outcome. "How often does someone smoke in your home? daily, weekly, monthly, less than monthly, never."
Time frame
3 and 6 months post-baseline2
Second-hand smoke exposure at home
Self-reported outcome. Number of days smoking occurred in the home in the past 7 days
Time frame
Past 7 days; 3 and 6 months post-baseline3
Complete smoke-free vehicle rule
Self-reported outcome. Question: "Which statement best describes the rules about smoking in your car: 1) we do not own a car; 2) there is no norm about smoking in a car and smoking is allowed; 3) smoking is allowed sometimes; 4) smoking is never allowed in a car".
Time frame
3 and 6 months post-baseline4
Among participants who smoke: Cigarette consumption
Cigarettes smoked per day; days smoked
Time frame
Past 7 days; assessed at 3 and 6 months post-baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Institut Català d'Oncologia
Lead sponsor
Emory University
Collaborator
Public Health Agency of Barcelona
Collaborator
Agència de Salut Pública de Catalunya (ASPCAT)
Collaborator
Source ClinicalTrials.gov