Effect of Weight Reduction Program on Overweight and Obese Children

NCT02381002 | Completed DMC

• 1 other identifier: FMASU 1078/2012
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Keywords

Serum ferritin, physical exercise, Diet

Outcome Measures

Primary Outcomes (1)

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

  6 months

Study Arms (1)

Weight reduction

EXPERIMENTAL

weight reduction program for 6 months

Other: Weight reduction program

Interventions

Weight reduction program OTHER

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.

Weight reduction

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

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

Cairo, Cairo Governorate, 11381, Egypt

Location

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity

Interventions

Weight Reduction Programs

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Health Promotion; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mohsen S Elalfy, PhD, MD

  Pediatric department, Faculty of Medicine , Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics , Faculty of Medicine

Study Record Dates

• First Submitted: March 1, 2015
• First Posted: March 5, 2015
• Study Start: March 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

EG (1)