The effect of a combined exercise training program (MRT1 and HIIT2) with nutritional advice on lipid profile, obesity index and quality of life in obese and overweight children and teenagers
The propose of this research is to determine the effect of a combined exercise training program (MRT1 and HIIT2) and nutritional advice on lipid profile, obesity index and quality of life in obese and overweight children and teenagers. It is a randomized double-blind control trial. The samples size is consist of 120 children and teenagers between 10-19 years old randomized in 4 groups: 1. MRT group 2.HIIT group 3. Combination group 4. Control group.
Before and after exercise they are checked with questionnaire kidscreen27, BMI and lipid profile. The research is conducted in 2017-2018 and research period per person would be 8 weeks.
Children and adolescents in a range of 10-19 years old without any disease, no medications history and with body mass index > 1SD of ideal BMI for age and sex.
Intervention groups
Children and adolescents in a range of 10-19 years old
Main outcome variables
BMI-LDL-HDL-Cholesterol-Triglyceride-quality of life-age-sex-Arm circumference-waist
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150428021987N4
Registration date:2018-05-11, 1397/02/21
Registration timing:registered_while_recruiting
Last update:2018-05-11, 1397/02/21
Update count:0
Registration date
2018-05-11, 1397/02/21
Registrant information
Name
alireza ahmadi
Name of organization / entity
medical university of isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 3295
Email address
alirezaahmadi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
the cardiac reaserch institute of isfahan
the reaserch institute of medical univercity of isfahan
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a combined exercise training program (MRT1 and HIIT2) with nutritional advice on lipid profile, obesity index and quality of life in obese and overweight children and teenagers
Public title
Effect of exercise on obesity and lipid profile
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children and adolescents in range of 10-19 years old without any disease, use no drugs with body mass index > 1SD of ideal BMI for age and sex
Exclusion criteria:
Any diseases related to obesity or limiting strict exercise (diabetes, heart disease,...), drug intake, professional sports activities.
Age
From 10 years old to 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Double-blinded
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and the nutritionists don't have information on investigated and controlled subjects.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Research Institute of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjarib street, Azadi square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Approval date
2017-08-14, 1396/05/23
Ethics committee reference number
IR.MUI.REC.1396.446755
Health conditions studied
1
Description of health condition studied
Obesity, Overweight
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Body Mass Index
Timepoint
In the beginning and 8 weeks later
Method of measurement
kg/m2
2
Description
Triglyceride
Timepoint
In the beginning and 8 weeks later
Method of measurement
gr/dL
3
Description
Cholestrol
Timepoint
In the beginning and 8 weeks later
Method of measurement
gr/dL
4
Description
HDL
Timepoint
In the beginning and 8 weeks later
Method of measurement
gr/dL
5
Description
LDL
Timepoint
In the beginning and 8 weeks later
Method of measurement
gr/dL
6
Description
quality of life
Timepoint
In the beginning and 8 weeks later
Method of measurement
guestionnaire kid screen 27
Secondary outcomes
empty
Intervention groups
1
Description
First group: High-Intensity Interval Training (HIIT) (After learning the practical steps and instructions in the rehabilitation center, they will exercise at home.)
Category
Lifestyle
2
Description
Second group: Metabolic Resistance Training (MRT)
Category
Lifestyle
3
Description
Third group: Combined exercises including Metabolic Resistance Training and High-Intensity Interval Training
Category
Lifestyle
4
Description
Fourth group: Control group which won't have any exercises
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Cardiovascular Research Center
Full name of responsible person
Alireza Ahmadi
Street address
Pediatric Cardiovascular Research Center, Isfahan Cardiovascular Research Center, Close to Chamran Hospital, Moshtagh 3rd Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۸۷۶۹۸۱۹۱
Phone
+98 31 3611 5313
Email
ahmadi_cardio@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pediatric Cardiovascular Research Center
Full name of responsible person
Alireza Ahmadi
Street address
Pediatric Cardiovascular Research Center, Isfahan Cardiovascular Research Center, Close to Chamran Hospital, Moshtagh 3rd Blvd., Isfahan
City
isfahan
Province
Isfehan
Postal code
۸۱۸۷۶۹۸۱۹۱
Phone
+98 31 3611 5212
Email
ahmadi_cardio@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pediatric Cardiovascular Research Center
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
ِDr Movahedian Attar
Street address
Hezar jarib Ave., Azadi square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 31 3611 5212
Email
ahmadi_cardio@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Pediatric Cardiovascular Research Center
Full name of responsible person
zohre navabi
Position
Masters degree
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Pediatric Cardiovascular Research Center, Isfahan Cardiovascular Research Center, Close to Chamran Hospital, Moshtagh 3rd Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۸۷۶۹۸۱۹۱
Phone
+98 31 3611 5212
Fax
Email
zs.navabi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pediatric Cardiovascular Research Center
Full name of responsible person
Alireza Ahmadi
Position
Pediatric Cardiologist
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Pediatric Cardiovascular Research Center, Isfahan Cardiovascular Research Center, Close to Chamran Hospital, Moshtagh 3rd Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۸۷۶۹۸۱۹۱
Phone
+98 31 3611 5212
Fax
Email
alirezaahmadi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pediatric Cardiovascular Research Center
Full name of responsible person
Alireza Ahmadi
Position
Pediatric Cardiologist
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Pediatric Cardiovascular Research Center, Isfahan Cardiovascular Research Center, Close to Chamran Hospital, Moshtagh 3rd Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۸۷۶۹۸۱۹۱
Phone
+98 31 3611 5212
Fax
Email
alirezaahmadi@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available