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

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Weight reduction program
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Childhood Obesity focused on measuring Serum ferritin, physical exercise, Diet

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Weight reduction

Arm Description

weight reduction program for 6 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 1, 2015
Last Updated
March 5, 2015
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT02381002
Brief Title
Effect of Weight Reduction Program on Overweight and Obese Children
Acronym
"ironobese"
Official Title
EVALUATION OF DIETARY REGIMEN AND PHYSICAL ACTIVITY ON IRON AND LIPID STATUS IN OVERWEIGHT AND OBESE CHILDREN 6 Months Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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 : 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. To assess the effect of 6 months dieting program on iron status improvement in overweight/obese children. To study the psychological basis of obesity in children as well as associated co-morbidities. 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: 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. Full clinical examination: including Systemic examination and blood pressure measurements. Anthropometric measurements which include weight, height and body mass index. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Serum ferritin, physical exercise, Diet

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weight reduction
Arm Type
Experimental
Arm Description
weight reduction program for 6 months
Intervention Type
Other
Intervention Name(s)
Weight reduction program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Successful weight reduction (>5% weight loss at 6 months).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohsen S Elalfy, PhD, MD
Organizational Affiliation
Pediatric department, Faculty of Medicine , Ain Shams University
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital, Faculty of Medicine, Ain Shams University
City
Cairo
ZIP/Postal Code
11381
Country
Egypt

12. IPD Sharing Statement

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Effect of Weight Reduction Program on Overweight and Obese Children

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