Childhood Obesity"ironobese"NCT02381002
Effect of Weight Reduction Program on Overweight and Obese Children
A study testing Weight reduction program in people with Childhood Obesity, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Weight reduction program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2012to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Overweight and obese children according to BMI percentiles with age between 6 and 12 years.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Children's Hospital, Faculty of Medicine, Ain Shams University
Cairo, Cairo Governorate, 11381
About this study
Official title: 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.
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 :
- 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.
- Conditions
- Childhood Obesity
- Being tested
- Weight reduction program
- Keywords
- Serum ferritin, physical exercise, Diet
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight reduction programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Weight reduction | Experimental | weight reduction program for 6 months Receives: Other: Weight reduction program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful weight reduction (>5% weight loss at 6 months).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startMar 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar M.A. Hassanein, MD, Ain Shams University
- Investigators
- Mohsen S Elalfy, PhD, MD, Study chair, Pediatric department, Faculty of Medicine , Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381002
- Sponsor's protocol ID
- FMASU 1078/2012
- Acronym
- "ironobese"
- Status last verified
- Mar 2015
- First submitted
- 1 Mar 2015
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF DIETARY REGIMEN AND PHYSICAL ACTIVITY ON IRON AND LIPID STATUS IN OVERWEIGHT AND OBESE CHILDREN 6 Months Prospective Study
- ClinicalTrials.gov ID
- NCT02381002
- Acronym / sponsor ID
- "ironobese" / FMASU 1078/2012
- Conditions
- Childhood Obesity
- Keywords
- Serum ferritin, physical exercise, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weight reduction | Experimental | Other: Weight reduction programweight reduction program for 6 months |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Overweight and obese children according to BMI percentiles with age between 6 and 12 years.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight reduction programOverweight 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. | Other | Weight reduction |
Primary outcome
Successful weight reduction (>5% weight loss at 6 months).
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohsen S Elalfy, PhD, MD study chair
Pediatric department, Faculty of Medicine , Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight reduction program in people with Childhood Obesity, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful weight reduction (>5% weight loss at 6 months). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.