NCT06946173

Brief Summary

Childhood obesity is one of the most serious public health challenges of the 21th century. The problem is global and is steadily affecting many low and middle income countries particularly in unbar settings. Although definition of obesity and overweight has changed over time, it can be defined as an excess of body fat. A study conducted by Williams et al. on 3.320 children in the age group of 5-18 years classified children as fat if their percentage of body fat was at least 25% for males and 30% for females respectively. European researcher above 85th percentile of body mass index BMI for age and obesity as at or above 95% percentile of BMI. It is widely accepted that increase in obesity results from an imbalance between many intake and expenditure with an increase in positive energy balance being closely associated with the life style adopted and the dietary with the life style adopted and the dietary intake preferences. Research has made important contributions to our understanding of the factors associated with obesity the ecological model by Division et al., suggest that child risk any intake , physical activity and sedentary behavior. The impact of such risk factors is moderated by factors such as age, gender, family characteristics parenting style, parent's life style also plays a role. Environmental factors such as school policies, demographics and parents work -related demands further influence eating and activity behaviors. Genetics are one of the biggest factors examined as a cause of obesity, some studies have found that BMI is 25-40% heritable. However, genetic susceptibility often needs to be coupled with contributing environmental and behavioral factors in order to affect weight. The genetic factor accounts for less than 5% of cases of childhood obesity. Therefore, while genetics can play a role in the development of obesity. It is not the cause of the dramatic increase in childhood obesity

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

April 9, 2025

Last Update Submit

January 2, 2026

Conditions

Keywords

obesitychildrenprimary schoolinterventionsobesity management

Outcome Measures

Primary Outcomes (6)

  • change in weight

    Egyptians growth charts each children will be subjected to full history talking

    6 months

  • change in height

    Egyptians growth charts each children will be subjected to clinical examination

    6 months

  • change in body mass index

    Egyptians growth charts each children will be subjected to growth assessment

    6 months

  • change in lipid profile

    Laboratory investigation will be done which include lipid profile

    6 months

  • change in serum cholesterol

    Laboratory investigation will be done which include serum cholesterol

    6 months

  • change in hemoglobin level

    Laboratory investigation will be done which include hemoglobin level

    6 months

Study Arms (1)

management group

EXPERIMENTAL

Two thousands children with ages ranging from 6-12 years who were borne and living in Gharbia Governorate attending the primary school in Gharbia Governorate including both male and female children Criteria of patients selection.

Dietary Supplement: health program

Interventions

health programDIETARY_SUPPLEMENT

Health children their age between 6-12 years bone and live in Gharbia governorate. \- Legal pre mission will be taken from each school movement system to assess over weight among there school children. \- The children and their family included in the study will be able to follow program of health intervention to prevent obesity. Materials and methods: 1. Each children will be subjected to full history talking , clinical examination, growth assessment; weight height and body mass index (BMI) for age percentile ( Egyptians growth charts) 2. Laboratory investigation will be done which include lipid profile, serum cholesterol, triglycerides, LDL and hemoglobin level 3. Child history will be taken which include personal history 4. Dietary history of the child which include eating habits

management group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Health children their age between 6-12 years bone and live in Gharbia governorate.
  • Legal pre mission will be taken from each school movement system to assess over weight among there school children.
  • The children and their family included in the study will be able to follow program of health intervention to prevent obesity.

You may not qualify if:

  • have active kidney your hepatic disease.
  • They have any endocrinal or genetic disorders.
  • The have diabetes mellitus and thyroid disease.
  • The children \& their family cannot follow instructions in the program of health interventions included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nadia Mahmoud Arfa

Tanta, Egypt

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed Bedair Ebrahim, professor of physical therapy

    kafr-elsheikh university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Intervention study model single assignment the study include two thousands children with ages ranging from 6-12 years who were borne and living in Gharbia Governorate attending the primary school in Gharbia Governorate including both male and female children Criteria of patients selection.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nadia Mahmoud Arfa

Study Record Dates

First Submitted

April 9, 2025

First Posted

April 27, 2025

Study Start

May 1, 2025

Primary Completion

November 1, 2025

Study Completion

December 30, 2025

Last Updated

January 7, 2026

Record last verified: 2026-01

Locations