Effect of Weight Reduction Program on Overweight and Obese Children ("ironobese")

March 5, 2015 updated by: Sahar M.A. Hassanein, MD, Ain Shams University

EVALUATION OF DIETARY REGIMEN AND PHYSICAL ACTIVITY ON IRON AND LIPID STATUS IN OVERWEIGHT AND OBESE CHILDREN 6 Months Prospective Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Weight reduction
weight reduction program for 6 months
Other: Weight 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Successful weight reduction (>5% weight loss at 6 months).
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Mohsen S Elalfy, PhD, MD, Pediatric department, Faculty of Medicine , Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

March 1, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (ESTIMATE)

March 5, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU 1078/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Childhood Obesity

Clinical Trials on Weight reduction program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe