NCT06757361

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

January 3, 2025

Status Verified

December 1, 2024

Enrollment Period

5 months

First QC Date

December 12, 2024

Last Update Submit

December 26, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    12 weeks

Eligibility Criteria

Age5 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

1. Chronological age range 5 :6 2. Both genders will be included

You may qualify if:

  • 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

You may not qualify if:

  • Any surgical intervention in mouth.
  • Any congenital anomaly in the mouth as cleft lips or cleft palate.
  • Oral disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy Cairo university

Helwan, Helwan, 11722, Egypt

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 12, 2024

First Posted

January 3, 2025

Study Start

October 1, 2024

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

January 3, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations