The Effect of a Zero Tolerance Program (SToP) on Child's Urine Cotinine Level According to Exposure Feedback

NCT05545748 | Completed

• 1 other identifier: 0015
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Second Hand Smoke; Exposure to Environmental Pollution; Child; Urine; Parents

Keywords

Urinary cotinine; Home environment

Outcome Measures

Primary Outcomes (1)

• 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.

  Change in Urine Cotinine Level at 3 and 6 months from baseline

Secondary Outcomes (3)

• The Information Form on Exposure to Secondhand Smoke

  Change in knowledge level at 3 and 6 months from baseline

• Attitude Form on Exposure to Secondhand and Third hand Smoking

  Change in attitude level at 3 and 6 months from baseline

• Beliefs About Third-Hand Smoke (THS) Scale

  Change in beliefs level at 3 and 6 months from baseline

Study Arms (2)

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

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.

Behavioral: Exposure Feedback Group

Interventions

Zero (0) Tolerance Program (SToP) BEHAVIORAL

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

Zero (0) Tolerance Program Group

Exposure Feedback Group BEHAVIORAL

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.

Exposure Feedback Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akdeniz University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Sebahat Gözüm

Antalya, 07058, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participating parents will not know which group they are. Also, when the data is analyzed by the statistician, she/he will not know which group it is.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.Sebahat Gozum

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 19, 2022
• Study Start: July 17, 2023
• Primary Completion: December 2, 2023
• Study Completion: May 2, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)