Eating Behavior DisordersNCT06757361
Effect of Screen Time Exposure on Eating Behaviour and Health Related Quality of Life
An observational study of Eating Behavior Disorders and Health-Related Quality of Life, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this observational study is to learn the effect of screen time exposure on eating behaviour and health related quality of life in normal preschool children. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior Disorders, Health-Related Quality of Life, Screen Time Exposure
- How many people
- 122 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to Apr 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 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 1. Chronological age range 5 :6 2. Both genders will be included
Who may be able to join
- Chronological age range 5 :6
- Both genders will be included
- According to score of screen dependency scale children stratified into Two Groups:
- Group A children score more than 24.5
- Group B children score less than 24.5
- Exclusion Criteria:Any children has one or more from the following criteria:
Show all 9Show fewer
- Any surgical intervention in mouth.
- Any congenital anomaly in the mouth as cleft lips or cleft palate.
- Oral disorders
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Screen Time Exposure on Eating Behaviour and Health Related Quality of Life in Normal Preschool Children
The goal of this observational study is to learn the effect of screen time exposure on eating behaviour and health related quality of life in normal preschool children.
Read the detailed description
Screen media devices have become an integral to daily life, especially for preschool children due to emerging technologies, increased marketing , widespread familial and societal use , and easy access to or ownership for young children. Common screen activities include watching television, digital video discs and videos, playing video games, and using apps . However ,excessive screen time, non-educational screen content, unsupervised and early screen exposure can have numerous potential negative effects on children's health .
Screen time can significantly affect quality of life in various ways, both positively and negatively. Regarding cognitive development, screens have the potential to enhance education and learning. However, studies have shown that excessive screen time can negatively affect executive functioning, sensorimotor development, and academic outcomes. Early screen exposure has been associated with lower cognitive abilities and academic performance in later years. Language development is also affected by screen time, as it diminishes the quantity and quality of interactions between children and caregivers. Excessive screen usage can also lead to problems in social-emotional development, including obesity, sleep disturbances, depression, and anxiety. It can impair emotional comprehension, promote aggressive behavior, and hinder social and emotional competence .
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Behavior in Preschool Children
Eating behaviour will be assessed in preschool children using a validated tool that evaluates overall eating habits, including Food Responsiveness, Enjoyment of Food, Emotional Overeating, Desire to Drink, Satiety Responsiveness, Slowness in Eating, Emotional Undereating, and Food Fussiness.
Measured: 12 weeks
Health-related quality of life (HRQoL)
Health-related quality of life (HRQoL) will be assessed in preschool children using a validated measurement tool. This tool evaluates the child's overall well-being, considering physical, emotional, social, and school functioning as part of a comprehensive assessment of quality of life.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Oct 2024
- Primary completion1 Mar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating Behavior DisordersStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennatallah Galal Mohamed Hassanein, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757361
- Sponsor's protocol ID
- P.T.REC/012/005461
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 3 Jan 2025
- 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 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Screen Time Exposure on Eating Behaviour and Health Related Quality of Life in Normal Preschool Children
- ClinicalTrials.gov ID
- NCT06757361
- Acronym / sponsor ID
- P.T.REC/012/005461
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 3 Jan 2025 (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.
The goal of this observational study is to learn the effect of screen time exposure on eating behaviour and health related quality of life in normal preschool children.
Detailed description
Screen media devices have become an integral to daily life, especially for preschool children due to emerging technologies, increased marketing , widespread familial and societal use , and easy access to or ownership for young children. Common screen activities include watching television, digital video discs and videos, playing video games, and using apps . However ,excessive screen time, non-educational screen content, unsupervised and early screen exposure can have numerous potential negative effects on children's health .
Screen time can significantly affect quality of life in various ways, both positively and negatively. Regarding cognitive development, screens have the potential to enhance education and learning. However, studies have shown that excessive screen time can negatively affect executive functioning, sensorimotor development, and academic outcomes. Early screen exposure has been associated with lower cognitive abilities and academic performance in later years. Language development is also affected by screen time, as it diminishes the quantity and quality of interactions between children and caregivers. Excessive screen usage can also lead to problems in social-emotional development, including obesity, sleep disturbances, depression, and anxiety. It can impair emotional comprehension, promote aggressive behavior, and hinder social and emotional competence .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 1. Chronological age range 5 :6 2. Both genders will be included
Key inclusion criteria (9 listed)
- Chronological age range 5 :6
- Both genders will be included
- According to score of screen dependency scale children stratified into Two Groups:
- Any surgical intervention in mouth.
- Any congenital anomaly in the mouth as cleft lips or cleft palate.
Key exclusion criteria (0 listed)
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
Eating Behavior in Preschool Children
Time frame: 12 weeks
Eating behaviour will be assessed in preschool children using a validated tool that evaluates overall eating habits, including Food Responsiveness, Enjoyment of Food, Emotional Overeating, Desire to Drink, Satiety Responsiveness, Slowness in Eating, Emotional Undereating, and Food Fussiness.
Health-related quality of life (HRQoL)
Time frame: 12 weeks
Health-related quality of life (HRQoL) will be assessed in preschool children using a validated measurement tool. This tool evaluates the child's overall well-being, considering physical, emotional, social, and school functioning as part of a comprehensive assessment of quality of life.
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 3 Jan 2025.
- 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?
An observational study of Eating Behavior Disorders and Health-Related Quality of Life, run by Cairo University at 1 site in Egypt.
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 9 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 3 Jan 2025. 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 Egypt. 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?
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?
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?
Eating Behavior in Preschool Children (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 3 Jan 2025.