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

NCT ID: NCT05545748

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-17
• Study Completion Date: 2024-05-02

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Zero (0) Tolerance Program Group

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

Group Type: EXPERIMENTAL

Zero (0) Tolerance Program (SToP)

Intervention Type: 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

Exposure Feedback Group

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.

Group Type: ACTIVE_COMPARATOR

Exposure Feedback Group

Intervention Type: 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.

Interventions

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

Intervention Type: BEHAVIORAL

Exposure Feedback Group

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.

Intervention Type: BEHAVIORAL

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Sebahat Gozum

Prof.Dr.Sebahat Gozum

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sebahat Gözüm

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

0015

Identifier Type: -

Identifier Source: org_study_id