Effect of Passive Smoking on Functional Capacity, Cognition and Academic Performance in Primary School Children

NCT06723470 | Not Yet Recruiting DMC

• 1 other identifier: P.T.REC/012/005358
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Smoke Exposure; Smokeless Tobacco

Keywords

Passive Smoking; Functional Capacity; Cognitive Abilities; Academic Performance; Children; Primary School; Physical Fitness

Outcome Measures

Primary Outcomes (1)

• 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.

  At the start of the study (baseline).

Secondary Outcomes (2)

• Impact of Passive Smoking on Cognitive Abilities in Primary School Children

  At the start of the study (baseline).

• Impact of Passive Smoking on Academic Performance in Primary School Children

  At the start of the study (baseline).

Study Arms (2)

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.

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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 unable to cooperate or participate in the assessments.

Sponsors & Collaborators

• Egyptian Chinese University: lead

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Nourhan M. Abd El_Aleem

CONTACT

+201091112543; Nmabdelaleem@ecu.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Pediatric Physical Therapy

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: December 15, 2024
• Primary Completion: September 15, 2025
• Study Completion: December 15, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12