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CompletedNCT02381002"ironobese"Updated Mar 6, 2015

Effect of Weight Reduction Program on Overweight and Obese Children

An interventional study of Weight reduction program in Childhood Obesity, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-06.

Sponsored by Ain Shams University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
6 Years to 12 Years
Sex
All
01

Study summary

Background: Obesity is associated with alterations in iron metabolism leading to iron deficiency.

Aim: to study the prevalence of obesity among primary school students, assess iron status among overweight/obese children with age ranging between 6 and 12 years and the effect of weight reduction program on iron status.

Patients and Methods: The study will be conducted on 2 groups. Group 1 will include 1025 primary school children recruited from 2 urban schools in Cairo with age ranging between 6 and 12. Anthropometric measures and prevalence of overweight/obesity will be assessed. Group 2 will include 100 obese children according to the CDC definition and 50 age and sex matched children with normal weight. All will be subjected to history taking, anthropometric measures, complete blood picture, iron profile and soluble transferrin receptor. Weight reduction program for 6 months will be done for obese children and all parameters will be re-ckecked.

Read the detailed description

SUMMARY Over the past 30 years, childhood overweight/obesity, often beginning in infancy and toddlerhood, has reached epidemic proportions, particularly among minority and/or low-income populations in high-income countries. Rates of pediatric obesity (BMI ≥ 95th percentile) have almost tripled over the past 25 years, with current estimates showing a prevalence rate of 16% for girls and 18% for boys. The prevalence of adolescent and childhood overweight and obesity in children living in Egypt, Brazil and Mexico has reached levels comparable to those seen in industrialized nations.

Obesity is associated with alterations in iron metabolism leading to iron deficiency which is probably the most prevalent single common micronutrient deficiency in the world today.

Aim of the study :

  1. To assess iron status among overweight/ obese primary school children. With age ranging from 6 years till preadolescence or age 12 years with Tanner score ≤ 2.
  2. To assess the effect of 6 months dieting program on iron status improvement in overweight/obese children.
  3. To study the psychological basis of obesity in children as well as associated co-morbidities.
  4. To assess the prevalence of obesity among primary school students.

The study will be conducted on 2 groups:

Group 1 1025 will be recruited from 2 urban primary schools with moderate-high social standards among children with age between 6 to 12 years.

Weight, height were measured and body mass index will be calculated. All measures will be plotted on the percentiles for age. The percentage of obese and overweight children will be calculated.

Group 2 will include 150 children, 100 obese children and 50 normal weight children with age ranging between 6 and 12 years.

All 150 subjects will be subjected to:

  1. A questionnaire: inquiring about personal data, Socioeconomic data, family history of obesity, weight related attitudes, physical exercise performance, personal believes about diet (self-efficacy, barriers to change and dietary believes), previous trials to lose weight and school performance.
  2. Full clinical examination: including

    1. Systemic examination and blood pressure measurements.
    2. Anthropometric measurements which include weight, height and body mass index.
  3. Laboratory investigations: complete blood picture, serum iron, ferritin, transferrin saturation, total iron binding capacity, soluble transferrin receptor, serum triglycerides and serum cholesterol.

All obese children will be subjected to weight reduction program which includes diet regimen, exercise and behavioral modification.

All anthropometric and laboratory measures will be measured again after the 6 months intervention.

02

Conditions studied

  • Childhood Obesity

Keywords

  • Serum ferritin, physical exercise, Diet
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 150 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Overweight and obese children according to BMI percentiles with age between 6 and 12 years.

Exclusion criteria

Exclusion Criteria:

  • Obesity caused by genetic syndromes, apparent endocrinal disease, psychiatric disorders or chronic inflammatory diseases (inflammatory bowel disease, autoimmune disease, cancer treated within the last year).
  • Children with chronic illness or blood disorders such as any identified risk for iron deficiency or a red cell disorder, vegan diet.
  • Children with Tanner>2
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Weight reduction

    weight reduction program for 6 months

    Other: Weight reduction program

Interventions

  • OtherWeight reduction program

    Overweight and obese children (6-12 years old) from patient group accepting enrollment were assigned to weight reduction program for 6 months with monthly follow up. The program comprise: 1) Diet regimen: Healthy balanced diet was prescribed. The amount of calories was determined according to 24-hour recall then 250-500 calories were subtracted from total intake which decrease weight by 0.25-0.5 kg/week. 2) Exercise:were instructed to practice walking for at least 30 minutes 3-4 times per week.

06

What researchers measure

Primary outcomes

  1. Successful weight reduction (>5% weight loss at 6 months).

    Time frame: 6 months

07

Study locations

1 site
  • Children's Hospital, Faculty of Medicine, Ain Shams University
    Cairo, 11381, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02381002
Lead sponsor
Ain Shams University
Responsible party
Sahar M.A. Hassanein, MD (Professor of Pediatrics , Faculty of Medicine, Ain Shams University) — Principal investigator
First posted
Mar 5, 2015
Start date
Mar 2012
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Mar 6, 2015

Study contacts

Mohsen S Elalfy, PhD, MD
study chair · Pediatric department, Faculty of Medicine , Ain Shams University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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