Smoke ExposureNCT06723470
Effect of Passive Smoking on Functional Capacity, Cognition and Academic Performance in Primary School Children
An observational study of Smoke Exposure and Smokeless Tobacco, run by Egyptian Chinese University.
Trial summary
This is an observational study that aims to understand the effects of passive smoking (secondhand smoke exposure) on children's health and development. The main question the study seeks to answer is: How does exposure to secondhand smoke affect the physical fitness, cognitive abilities, and academic performance of… Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoke Exposure, Smokeless Tobacco
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2024to 15 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population consists of 90 primary school children aged 6-11 years, selected from various primary schools in Cairo, Egypt. These children are categorized into two groups: 45 children exposed to secondhand smoke (passive smokers) and 45 children not exposed to secondhand smoke (non-smokers). All children are healthy and without any cognitive, visual, or musculoskeletal impairments. The children in the passive smokers group have parents who have been smoking for at least 6 years with moderate to high levels of smoking exposure. The non-smokers group consists of children who are not exposed to secondhand smoke at home or in their environments. The children's participation is voluntary, with informed consent obtained from parents or guardians.
Who may be able to join
- Children aged 6-11 years, enrolled in primary school.
- Both genders (male and female).
- Healthy children with no musculoskeletal, visual, auditory, or cognitive impairments.
- Children whose parents have been smoking for at least 6 years, with moderate to high smoking levels (based on the smoking index).
- Children residing in a moderate socioeconomic status.
- Children living in Cairo, Egypt.
- Children who are able to follow simple commands and participate in assessments.
Who cannot join
- Children with musculoskeletal problems, congenital deformities, visual or auditory defects, learning disabilities, or autism.
- Children who are currently taking medications that affect alertness or cognitive function.
- Children who are not exposed to secondhand smoke (non-smokers) but have parents who smoke at very low levels or do not meet the inclusion criteria for passive smoking exposure.
- Children who are unable to cooperate or participate in the assessments.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This is an observational study that aims to understand the effects of passive smoking (secondhand smoke exposure) on children's health and development. The main question the study seeks to answer is:
How does exposure to secondhand smoke affect the physical fitness, cognitive abilities, and academic performance of primary school children?
Read more
The study will compare two groups of children aged 6-11 years: one group exposed to secondhand smoke at home (due to parents or caregivers who smoke) and another group not exposed to secondhand smoke. The children's physical capacity, cognitive skills, and school performance will be assessed through various tests.
The goal of the study is to provide valuable insights into how secondhand smoke may negatively impact children, helping families, schools, and healthcare providers understand the risks and promote healthier, smoke-free environments for children.
Read the detailed description
This observational study aims to assess the effects of passive smoking on functional capacity, cognitive abilities, and academic performance in primary school children aged 6-11 years. The study will compare two groups: children exposed to secondhand smoke (passive smokers) and children not exposed (non-smokers).
Children in the passive smoking group have one or both parents who have been smoking for at least six years, with moderate to high levels of exposure based on a smoking index. These children will be compared with children in the non-smoking group who are not exposed to secondhand smoke at home or in other environments. The study will focus on three primary outcome areas:
- Functional Capacity: Measured by the 3-Minute Step Test to assess cardiorespiratory fitness and physical performance.
- Cognitive Abilities: Evaluated using the Wechsler Intelligence Scale for Children (WISC-V), which measures various cognitive functions, including verbal comprehension, working memory, and processing speed.
- Academic Performance: Assessed using the Academic Performance Rating Scale (APRS), which provides an evaluation of the child's academic success, attention, and classroom behavior.
This study will not involve any interventions, as it is observational in nature. Instead, it will collect data to identify differences in physical, cognitive, and academic outcomes based on passive smoking exposure. All data collection will occur at baseline, with the assessments conducted in a controlled, quiet environment to minimize distractions.
The sample will consist of 90 children (45 in each group), with participation based on inclusion and exclusion criteria. Children will be selected from primary schools in Cairo, Egypt, where parents have provided informed consent for participation. The study results will contribute valuable insights into the negative effects of secondhand smoke on children's health and development, which can guide health care providers, educators, and families in promoting smoke-free environments for children.
- Conditions
- Smoke Exposure, Smokeless Tobacco
- Keywords
- Passive Smoking, Functional Capacity, Cognitive Abilities, Academic Performance, Children, Primary School, Physical Fitness
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Passive Smokers | This group includes children aged 6-11 years who are exposed to secondhand smoke at home. At least one parent or caregiver is a smoker, with a smoking history of no less than six years. The level of exposure is categorized as moderate to high based on the smoking index (number of cigarettes per day multiplied by years of smoking). | |
| Group 2: Non-Smokers | This group includes children aged 6-11 years who are not exposed to secondhand smoke at home or in other environments. Neither parent nor caregiver is a smoker, ensuring no passive smoke exposure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Passive Smoking on Functional Capacity in Primary School Children
Functional capacity will be assessed using the 3-Minute Step Test (3MST). This test measures cardiorespiratory fitness by evaluating the total number of completed step cycles (up and down) within 3 minutes and the heart rate recovery one minute post-exercise. The reported outcomes will include:
Number of steps completed (unit: step cycles). Heart rate recovery (unit: beats per minute). These outcomes will be analyzed separately. Higher heart rate recovery values indicate worse cardiorespiratory fitness, whereas more completed step cycles indicate better fitness.
Measured: At the start of the study (baseline).
Secondary outcomes (2)
Impact of Passive Smoking on Cognitive Abilities in Primary School Children
Cognitive abilities will be assessed using the Wechsler Intelligence Scale for Children (WISC-V). The WISC-V provides composite scores in five domains:
Verbal Comprehension Index (VCI): range 50-150. Working Memory Index (WMI): range 50-150. Processing Speed Index (PSI): range 50-150. Fluid Reasoning Index (FRI): range 50-150. Full-Scale IQ (FSIQ): range 50-150. Higher scores indicate better cognitive functioning in each domain.
Measured: At the start of the study (baseline).
Impact of Passive Smoking on Academic Performance in Primary School Children
Academic performance will be assessed using the Academic Performance Rating Scale (APRS). This scale includes 19 items, each rated on a 5-point Likert scale (1 = poor, 5 = excellent). The total score ranges from 19 to 95, with higher scores indicating better academic performance.
Measured: At the start of the study (baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start15 Dec 2024 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoke ExposureStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egyptian Chinese University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Abdelaleem, Egyptian Chinese University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723470
- Sponsor's protocol ID
- P.T.REC/012/005358
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Passive Smoking on Functional Capacity, Cognition and Academic Performance in Primary School Children
- ClinicalTrials.gov ID
- NCT06723470
- Acronym / sponsor ID
- P.T.REC/012/005358
- Conditions
- Smoke Exposure, Smokeless Tobacco
- Keywords
- Passive Smoking, Functional Capacity, Cognitive Abilities, Academic Performance, Children, Primary School, Physical Fitness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Egyptian Chinese UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 9 Dec 2024 (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.
This is an observational study that aims to understand the effects of passive smoking (secondhand smoke exposure) on children's health and development. The main question the study seeks to answer is:
How does exposure to secondhand smoke affect the physical fitness, cognitive abilities, and academic performance of primary school children?
The study will compare two groups of children aged 6-11 years: one group exposed to secondhand smoke at home (due to parents or caregivers who smoke) and another group not exposed to secondhand smoke. The children's physical capacity, cognitive skills, and school performance will be assessed through various tests.
The goal of the study is to provide valuable insights into how secondhand smoke may negatively impact children, helping families, schools, and healthcare providers understand the risks and promote healthier, smoke-free environments for children.
Detailed description
This observational study aims to assess the effects of passive smoking on functional capacity, cognitive abilities, and academic performance in primary school children aged 6-11 years. The study will compare two groups: children exposed to secondhand smoke (passive smokers) and children not exposed (non-smokers).
Children in the passive smoking group have one or both parents who have been smoking for at least six years, with moderate to high levels of exposure based on a smoking index. These children will be compared with children in the non-smoking group who are not exposed to secondhand smoke at home or in other environments. The study will focus on three primary outcome areas:
- Functional Capacity: Measured by the 3-Minute Step Test to assess cardiorespiratory fitness and physical performance.
- Cognitive Abilities: Evaluated using the Wechsler Intelligence Scale for Children (WISC-V), which measures various cognitive functions, including verbal comprehension, working memory, and processing speed.
- Academic Performance: Assessed using the Academic Performance Rating Scale (APRS), which provides an evaluation of the child's academic success, attention, and classroom behavior.
This study will not involve any interventions, as it is observational in nature. Instead, it will collect data to identify differences in physical, cognitive, and academic outcomes based on passive smoking exposure. All data collection will occur at baseline, with the assessments conducted in a controlled, quiet environment to minimize distractions.
The sample will consist of 90 children (45 in each group), with participation based on inclusion and exclusion criteria. Children will be selected from primary schools in Cairo, Egypt, where parents have provided informed consent for participation. The study results will contribute valuable insights into the negative effects of secondhand smoke on children's health and development, which can guide health care providers, educators, and families in promoting smoke-free environments for children.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Passive Smokers | – | –This group includes children aged 6-11 years who are exposed to secondhand smoke at home. At least one parent or caregiver is a smoker, with a smoking history of no less than six years. The level of exposure is categorized as moderate to high based on the smoking index (number of cigarettes per day multiplied by years of smoking). |
| Group 2: Non-Smokers | – | –This group includes children aged 6-11 years who are not exposed to secondhand smoke at home or in other environments. Neither parent nor caregiver is a smoker, ensuring no passive smoke exposure. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population consists of 90 primary school children aged 6-11 years, selected from various primary schools in Cairo, Egypt. These children are categorized into two groups: 45 children exposed to secondhand smoke (passive smokers) and 45 children not exposed to secondhand smoke (non-smokers). All children are healthy and without any cognitive, visual, or musculoskeletal impairments. The children in the passive smokers group have parents who have been smoking for at least 6 years with moderate to high levels of smoking exposure. The non-smokers group consists of children who are not exposed to secondhand smoke at home or in their environments. The children's participation is voluntary, with informed consent obtained from parents or guardians.
Key inclusion criteria (7 listed)
- Children aged 6-11 years, enrolled in primary school.
- Both genders (male and female).
- Healthy children with no musculoskeletal, visual, auditory, or cognitive impairments.
- Children whose parents have been smoking for at least 6 years, with moderate to high smoking levels (based on the smoking index).
- Children residing in a moderate socioeconomic status.
Key exclusion criteria (4 listed)
- Children with musculoskeletal problems, congenital deformities, visual or auditory defects, learning disabilities, or autism.
- Children who are currently taking medications that affect alertness or cognitive function.
- Children who are not exposed to secondhand smoke (non-smokers) but have parents who smoke at very low levels or do not meet the inclusion criteria for passive smoking exposure.
- Children who are unable to cooperate or participate in the assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impact of Passive Smoking on Functional Capacity in Primary School Children
Time frame: At the start of the study (baseline).
Functional capacity will be assessed using the 3-Minute Step Test (3MST). This test measures cardiorespiratory fitness by evaluating the total number of completed step cycles (up and down) within 3 minutes and the heart rate recovery one minute post-exercise. The reported outcomes will include: Number of steps completed (unit: step cycles). Heart rate recovery (unit: beats per minute). These outcomes will be analyzed separately. Higher heart rate recovery values indicate worse cardiorespiratory fitness, whereas more completed step cycles indicate better fitness.
2 secondary outcomes
Impact of Passive Smoking on Cognitive Abilities in Primary School Children
Time frame: At the start of the study (baseline).
Impact of Passive Smoking on Academic Performance in Primary School Children
Time frame: At the start of the study (baseline).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoke Exposure and Smokeless Tobacco, run by Egyptian Chinese University.
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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nourhan M. Abd El_Aleem (+201091112543, Nmabdelaleem@ecu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Passive Smoking on Functional Capacity in Primary School Children (time frame: At the start of the study (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 18 Dec 2024.