Clinical trial NCT05545748: The Effect of a Zero Tolerance Program (SToP) on Child's Urine Cotinine Level According to Exposure Feedback
Official title: The Effect of a Zero Tolerance Program (SToP) Applied to Parents of Children at High Risk of Secondhand Tobacco Smoke Exposure on Child's Urine Cotinine Level According to Exposure Feedback: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Second Hand Smoke
Exposure to Environmental Pollution
Child
Urine
Parents
Keywords: Urinary cotinine
Home environment
Lead sponsor: Akdeniz University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2022-09-19
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Although the ban on indoor smoking has greatly reduced secondhand smoke (SHS) exposure in public spaces, the home environment is still the primary source of exposure to SHS, particularly in children under the age of five. Although attempts are often made to prevent or reduce children's exposure to SHS, such as education, counseling, and exposure feedback to parents, exposure remains. Although using materials such as brochures, messages, posters and reminders that will minimize the harms such as protecting children from SHS will reduce the exposure, exposure continues in the long term.The aim of this study is to compare the effect of giving exposure feedback to the parents according to the zero tolerance program (SToP) on the urinary cotinine level of the children. In this study with active control group, single-blind (participant), randomized control, stratified block randomization (1:1) will be performed. Totally 58 participants including STOP intervention group (n:29) and the exposure feedback group (n:29), which is the active control group, were planned to be included in the study, which was planned to be conducted between January and September 2023. Cotinine-sensitive dipstick test kits will be used for the primary outcome (urine cotinine). Cotinine-sensitive dipstick test kit is a simple, cost-effective test to determine smoking status. It is an easy-to-read test strip that can be used with either a saliva or a urine sample. Secondary outcomes will be evaluated by information form on exposure to second-hand smoke, an attitude form on exposure to second-hand smoke, and a scale of beliefs towards third-hand smoke. This protocol will demonstrate whether SToP interventions, a sustainable program for children at high risk of secondhand tobacco exposure, are a viable intervention for parents on how to reduce exposure.


Eligibility criteria: Inclusion Criteria:

* Parents with children aged 5 and under, whose children are registered with the Family Health Center, and whose children are at high and very high risk of exposure to SHS according to the risk algorithm.
* Parents' willingness to participate in the study

Exclusion Criteria:

* Babysitter
* Those who do not speak Turkish.
* Parents of children with asthma will not be included on the grounds that it may be confusing as they may display more specific behavior.

Primary outcomes:
measure: Urine Cotinine Level
timeFrame: Change in Urine Cotinine Level at 3 and 6 months from baseline
Secondary outcomes:
measure: The Information Form on Exposure to Secondhand Smoke
timeFrame: Change in knowledge level at 3 and 6 months from baseline
measure: Attitude Form on Exposure to Secondhand and Third hand Smoking
timeFrame: Change in attitude level at 3 and 6 months from baseline
measure: Beliefs About Third-Hand Smoke (THS) Scale
timeFrame: Change in beliefs level at 3 and 6 months from baseline
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Sebahat Gözüm
Study officials:
References: