The overall purpose of this study is to investigate the effect of a period of intermittent exercise and motor skills on MIR15b and MIR146b expression and lipid profile in overweight and obese adolescents.
Design
This clinical trial has two experimental groups and a control group, which will be formed using cluster method. 225 students between 13 to 15 years old from schools in Lordegan city, after selection will be randomly matched based on body mass index in control and experimental groups. G power software will be used to divide people into groups based on body mass index.
Settings and conduct
The statistical population of this study will be obese and overweight students of the first secondary schools of Lordegan city with an age range of 13 to 15 years with body mass index higher than 85 percent. The research method of the present study will be semi -experimental with a pre-test-post-test experimental design with a control group that will be conducted in the field.
Participants/Inclusion and exclusion criteria
Inclusion criteria: healthy adolescents; age range 13 to 15 years; body mass index above 85%; absence of any disease. Exclusion criteria: voluntary withdrawal of participants for any reason, disease or Inability to exercise during the research period, injury during exercise and absence in more than three sessions during the training period.
Intervention groups
high intensity interval training (HIIT), selected school-based (SBE) and control groups
Main outcome variables
MIR146b, MIR15b levels, lipid profiles
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200515047455N1
Registration date:2020-11-16, 1399/08/26
Registration timing:retrospective
Last update:2020-11-16, 1399/08/26
Update count:0
Registration date
2020-11-16, 1399/08/26
Registrant information
Name
Rasol Khaliltahmasebi
Name of organization / entity
The University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 38 3444 1733
Email address
r.tahmasebi110@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2019-01-20, 1397/10/30
Trial completion date
2019-12-21, 1398/09/30
Scientific title
The effect of a period of exercise interventions on expression in MIR15b and MIR146b in overweight and obese boys adolescents
Public title
The effect of a period of exercise interventions on expression of MIR15b and MIR146b
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy teens
aged 13 to 15 years
body mass index above 85%
no any disease
Exclusion criteria:
Get sick
Inability to perform exercises during the research period
Injury during exercise
Absence for more than three sessions
Age
From 11 years old to 15 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Actual sample size reached:
45
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8891153311
Approval date
2019-07-30, 1398/05/08
Ethics committee reference number
IR.UI.REC.1399.054
Health conditions studied
1
Description of health condition studied
overweight and obesity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
MIR15b level
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
The MIR15b was extracted using a Real Time PCR system.
2
Description
MIR146b level
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
The MIR15b was extracted using a Real Time PCR system.
3
Description
Lipid profile
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Elayza methood
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: High intensity interval Ttraining include running a certain distance of 20 meters for 30 seconds and 30 seconds of active rest between activities. Participants perform a 20-meter reciprocating test to the point of fatigue to measure peak oxygen consumption and maximum aerobic velocity under the same environmental conditions. The distance that each person has to run in 30 seconds is calculated based on the maximum speed that he achieves in the 20-meter round trip test, and this distance increases every two weeks according to the new record.
Category
Treatment - Other
2
Description
Intervention group: The program of the school-based training group includes a 20-meter round-robin test, basic futsal skills training, futsal games, and sit-ups
Category
Treatment - Other
3
Description
Control group: the control group did not participate in any specific training program during this period
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Univercity
Full name of responsible person
Rasol Khaliltahmasebi
Street address
Hezar Jarib Isfaha Town
City
Isfahan
Province
Isfehan
Postal code
88911533111
Phone
+98 38 3444 1733
Fax
+98 38 3444 1733
Email
r.tahmasebi110@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of medical Sciences
Full name of responsible person
Rasol Khaliltahmasebi
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8891153311
Phone
+98 38 3444 9187
Email
r.tahmasebi110@gmail.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
Isfahan University of medical Sciences
Full name of responsible person
Rasol Khaliltahmasebi
Position
PhD Candidate, Faculty of Sport Sciences, University of Isfahan
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8891153311
Phone
+98 38 3444 1733
Email
r.tahmasebi110@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Rasol Khaliltahmasebi
Position
PhD Candidate, Faculty of Sport Sciences
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8891153311
Phone
+98 38 3444 1733
Email
r.tahmasebi110@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of medical Sciences
Full name of responsible person
Rasol Khaliltahmasebi1
Position
PhD Candidate, Faculty of Sport Sciences
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8891153311
Phone
+98 38 3444 1733
Email
r.tahmasebi110@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document