Comparative Effectiveness of Dietary and Physical Activities Counseling on Components of Metabolic Syndrome in School Age Children With Metabolic Syndrom
Study objective :To rdtermine the effectiveness of dietary and Physical activities counseling on components of metabolic syndrome in school age children with metabolic syndrom.
This study is a randomized clinical trial.
Key inclusion and exclusion criteria:
1 - Diagnosis of metabolic syndrome defined according to the International Diabetes Federation and the doctor
2 - The minimum age is 12 years and maximum 6 years
3 - with the patient and the patient's caregivers Bymarbashd lives.
4 - Children and parents are willing to participate in the study.
5 - patients and families who have not previously participated in the training groups.
6 - no use of drugs affecting lipid metabolism, glucose and blood pressure
7 - at least not to participate in a training session.
The study population consisted of school children aged 6 to 12 with metabolic syndrome and a sample size is 60.
Study interventions included:
nutrition education intervention on a group of 15 peopleو Physical activity education intervention on a group of 15 people, Physical activity and nutrition education intervention on a group of 15 people and a group of 15 people without any intervention. Intervention period is three months. Before and after the interventions waist circumference, blood pressure, triglycerides, high-density lipoprotein and glucose is measured and differences are evaluated
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013110815318N1
Registration date:2013-12-20, 1392/09/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-20, 1392/09/29
Registrant information
Name
Roya Bagheri
Name of organization / entity
Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 916 322 7656
Email address
bagheri.r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effectiveness of Dietary and Physical Activities Counseling on Components of Metabolic Syndrome in School Age Children With Metabolic Syndrom
Public title
The effect of dietary and Physical activities counseling on children with metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria for intervention:
1 - Diagnosis of metabolic syndrome defined according to the International Diabetes Federation and the doctor
2 - The minimum age is 12 years and maximum 6 years
3 - with the patient and the patient's caregivers Bymarbashd lives.
4 - Children and parents are willing to participate in the study.
5 - patients and families who have not previously participated in the training groups.
6 - no use of drugs affecting lipid metabolism, glucose and blood pressure
Exclusion criteria for intervention:
1 - at least not to participate in a training session.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Science, Golestan Autobahn, Ahvaz
City
Ahvaz
Postal code
1579461357
Approval date
2013-10-05, 1392/07/13
Ethics committee reference number
ajums.REC.1392.141
Health conditions studied
1
Description of health condition studied
metabolic syndrome
ICD-10 code
E88
ICD-10 code description
Metabolic disorder, unspecified
Primary outcomes
1
Description
Abdominal obesity (waist Circumference )
Timepoint
Before intervention, Two months after intervention, four months after intervention
Method of measurement
waist Circumference According to cm by Using a height gauge
2
Description
Blood Pressure
Timepoint
Before intervention, Two months after intervention, four months after intervention
Method of measurement
According to Millimeters of mercury and by useing Manometer
3
Description
Triglycerides
Timepoint
Before intervention, Two months after intervention, four months after intervention
Method of measurement
According to Mg per deciliter by Using blood samples
4
Description
High-density lipoprotein
Timepoint
Before intervention, Two months after intervention, four months after intervention
Method of measurement
According to Mg per deciliter by Using blood samples
5
Description
Fast Blood Suger
Timepoint
Before intervention, Two months after intervention, four months after intervention
Method of measurement
According to Mg per deciliter by Using blood samples
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A:
Children and their parents will be placed in a group based nutrition education program. The training consisted of four consecutive and An interval of one week and Time is 120 minutes.These sessions will be led by the researcher.
Category
Lifestyle
2
Description
Intervention group B:
Children and their parents will be placed in a group based Physical activity education program. The training consisted of four consecutive and An interval of one week and Time is 120 minutes.These sessions will be led by the researcher.
Category
Lifestyle
3
Description
Intervention group c:
Children and their parents will be placed in a group based on both physical activity and nutrition education program .Tutorial sessions for eight consecutive, Twice in a week and four weeks , time will be 120 minutes .These sessions will be led by the researcher.
Category
Lifestyle
4
Description
The control group:
in this period will not be under any kind of formal training (no action)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialist Clinic of Golestan Hospital
Full name of responsible person
Roya Bagheri
Street address
Golestan Hospital, Golestan Street
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ashraf Alsadat Hakim
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ashraf Alsadat Hakim
Position
Bachelor of Nursing
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
6135715794
Phone
+98 61 1373 8622
Fax
Email
hakim – a@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ashraf alsadat hakim
Position
Educator
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Autobahn
City
Ahvaz
Postal code
6135715794
Phone
+98 61 1373 8622
Fax
Email
hakim – a@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Roya Bagheri
Position
Graduate Student
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Autobahn
City
Ahvaz
Postal code
6135715794
Phone
+98 61 1373 8622
Fax
Email
bagheri.r@ajums.ac.irroooyya@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)