Second Hand SmokeSToPNCT05545748
The Effect of a Zero Tolerance Program (SToP) on Child's Urine Cotinine Level According to Exposure Feedback
A study testing Zero (0) Tolerance Program (SToP) and Exposure Feedback Group in people with Second Hand Smoke and Exposure to Environmental Pollution, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Second Hand Smoke, Exposure to Environmental Pollution, Child
- What is being tested?
- Zero (0) Tolerance Program (SToP) and Exposure Feedback Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jul 2023to 2 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Second Hand Smoke, Exposure to Environmental Pollution, Child, Urine, Parents
- Being tested
- Zero (0) Tolerance Program (SToP), Exposure Feedback Group
- Keywords
- Urinary cotinine, Home environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zero (0) Tolerance Program (SToP)Behavioural
- Urine Cotinine Feedback: Explaining what the cotinine-sensitive dipstick test kit score mean. 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.
- Giving reminder objects (Magnet, sticker): For example; at the entrance door of the house: "0 TOLERANCE" magnet to cigarettes; "No smoking in my home" label.
- Informative materials (information notes and brochures): Brochures on the harms of second-hand smoking (SHS) and third-hand smoking (THS), the diseases they cause, and how to protect them
- Informative telephone text messages: Reminder phone messages related to SHS and THS
Exposure Feedback GroupBehavioural
- Urine Cotinine Feedback: Explaining what the cotinine-sensitive dipstick test kit score mean. 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.
| Study group | Role | What they receive |
|---|---|---|
| Zero (0) Tolerance Program Group | Experimental | The intervention to this group consists of four parts.
1. Urine Cotinine Feedback: Explaining what the cotinine-sensitive dipstick test kit score and color scale mean. 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.
2. Giving reminder objects (Magnet, sticker): For example; at the entrance door of the house: "0 TOLERANCE" magnet to cigarettes; "No smoking in my home" label.
3. Informative Materials (Information Notes and Brochures): Brochures on the harms of second-hand smoking (SHS) and third-hand smoking (THS), the diseases they cause, and how to protect them
4. Informative Telephone Text Messages: Reminder phone messages related to SHS and THS Receives: Behavioral: Zero (0) Tolerance Program (SToP) |
| Exposure Feedback Group | Active comparator | This group will receive only exposure feedback Urine Cotinine Feedback: Explaining what the cotinine-sensitive dipstick test kit score and color scale mean. 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. Receives: Behavioral: Exposure Feedback Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Cotinine Level
The child's urine sample taken at any time will be analyzed with the cotinine-sensitive dipstick test kit to assess the urine cotinine level. Urine samples will be tested in accordance with the manufacturer's instructions. The test has over 99% sensitivity in detecting cotinine with a cut-off level of 200 ng/ml and a minimum detection time of 2-8 hours and a maximum detection time of 1-7 days. After the test is immersed in the urine collection container for 10 seconds, the result becomes clear within 5 minutes. If the test is negative, the control (C) and test (T) line appear. If the test is positive, only the control line (C) appears. If the C and T lines are not visible or the C line is visible, it means that the test is invalid. Each test sample will be read and recorded by two independent observers.
Measured: Change in Urine Cotinine Level at 3 and 6 months from baseline
Secondary outcomes (3)
The Information Form on Exposure to Secondhand Smoke
The information form created by the researchers consists of 16 items: for each item; right, wrong, I don't know, can choose one of the options. Each item is scored between 0 and 1 according to the answer given. Accordingly, scores ranging from 0-13 for the first section, 0-3 for the second section, and 0-16 for the sum of the information items are taken. An increase in the score is interpreted as good knowledge of SHS and THS. The Kuder Richardson 20 (KR-20) value of all items was found to be 0.84.
Measured: Change in knowledge level at 3 and 6 months from baseline
Attitude Form on Exposure to Secondhand and Third hand Smoking
There are 8 attitude statements in the Household Attitude Form on Exposure of Children Under Five to Secondhand Smoking. 1 point for positive attitude statements and 0 (zero) points for negative attitude statements. Accordingly, the attitude score for exposure to second-hand smoking can be taken between 0-6, the tobacco attitude score for third-hand exposure 0-2, and the total attitude score to 0-8. A high score indicates a positive attitude.The KR-20 value of the expressions related to second-hand smoking exposure was found to be 0.84, the Kuder Richardson 20 (KR-20) value of the expressions related to the third-hand smoking exposure was found to be 0.53 and the KR-20 value of the total attitude expressions was 0.77.
Measured: Change in attitude level at 3 and 6 months from baseline
Beliefs About Third-Hand Smoke (THS) Scale
The scale, which consists of nine items, is answered in a 5-point Likert type. The scale was developed in United States in 2017 to determine beliefs about Third-Hand Smoke (THS). The Turkish validity and reliability study of the scale was carried out in 2019. As the score from the scale gets closer to 5, it is interpreted that the individual believes in the effects of THS on the environment and health, and as it approaches 1, the individual does not believe in the effects of THS on the environment and health.
Measured: Change in beliefs level at 3 and 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start17 Jul 2023
- Primary completion2 Dec 2023
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Second Hand SmokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Sebahat Gozum, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545748
- Sponsor's protocol ID
- 0015
- Acronym
- SToP
- Status last verified
- Jul 2024
- First submitted
- 12 Sep 2022
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05545748
- Acronym / sponsor ID
- SToP / 0015
- Conditions
- Second Hand Smoke, Exposure to Environmental Pollution, Child, Urine, Parents
- Keywords
- Urinary cotinine, Home environment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 2 Dec 2023 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zero (0) Tolerance Program Group | Experimental | Behavioral: Zero (0) Tolerance Program (SToP)The intervention to this group consists of four parts. 1. Urine Cotinine Feedback: Explaining what the cotinine-sensitive dipstick test kit score and color scale mean. 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. 2. Giving reminder objects (Magnet, sticker): For example; at the entrance door of the house: "0 TOLERANCE" magnet to cigarettes; "No smoking in my home" label. 3. Informative Materials (Information Notes and Brochures): Brochures on the harms of second-hand smoking (SHS) and third-hand smoking (THS), the diseases they cause, and how to protect them 4. Informative Telephone Text Messages: Reminder phone messages related to SHS and THS |
| Exposure Feedback Group | Active comparator | Behavioral: Exposure Feedback GroupThis group will receive only exposure feedback Urine Cotinine Feedback: Explaining what the cotinine-sensitive dipstick test kit score and color scale mean. 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zero (0) Tolerance Program (SToP)1. Urine Cotinine Feedback: Explaining what the cotinine-sensitive dipstick test kit score mean. 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. 2. Giving reminder objects (Magnet, sticker): For example; at the entrance door of the house: "0 TOLERANCE" magnet to cigarettes; "No smoking in my home" label. 3. Informative materials (information notes and brochures): Brochures on the harms of second-hand smoking (SHS) and third-hand smoking (THS), the diseases they cause, and how to protect them 4. Informative telephone text messages: Reminder phone messages related to SHS and THS | Behavioural | Zero (0) Tolerance Program Group |
| Exposure Feedback Group1. Urine Cotinine Feedback: Explaining what the cotinine-sensitive dipstick test kit score mean. 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. | Behavioural | Exposure Feedback Group |
Primary outcome
Urine Cotinine Level
Time frame: Change in Urine Cotinine Level at 3 and 6 months from baseline
The child's urine sample taken at any time will be analyzed with the cotinine-sensitive dipstick test kit to assess the urine cotinine level. Urine samples will be tested in accordance with the manufacturer's instructions. The test has over 99% sensitivity in detecting cotinine with a cut-off level of 200 ng/ml and a minimum detection time of 2-8 hours and a maximum detection time of 1-7 days. After the test is immersed in the urine collection container for 10 seconds, the result becomes clear within 5 minutes. If the test is negative, the control (C) and test (T) line appear. If the test is positive, only the control line (C) appears. If the C and T lines are not visible or the C line is visible, it means that the test is invalid. Each test sample will be read and recorded by two independent observers.
3 secondary outcomes
The Information Form on Exposure to Secondhand Smoke
Time frame: Change in knowledge level at 3 and 6 months from baseline
Attitude Form on Exposure to Secondhand and Third hand Smoking
Time frame: Change in attitude level at 3 and 6 months from baseline
Beliefs About Third-Hand Smoke (THS) Scale
Time frame: Change in beliefs level at 3 and 6 months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zero (0) Tolerance Program (SToP) and Exposure Feedback Group in people with Second Hand Smoke and Exposure to Environmental Pollution, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine Cotinine Level (time frame: Change in Urine Cotinine Level at 3 and 6 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.