obese/overweight to investigate the continuous and interval aerobic training on the levels of energy homeostasis regulating biomarkers in obese/overweight girls 9-11 years old.
Design
Clinical trials with the control group, with parallel groups, one blind, randomized.
Settings and conduct
The study population will be composed of obese/overweight school girls in Babolsar city, which will be selected in accessible form and divided randomly into two groups of exercise intervention and one control group. Exercise Interventions will be conducted at the Sports Hall of the College of Sport Sciences of Mazandaran University.
Participants/Inclusion and exclusion criteria
The 9-11-year-old obese/overweight girls who are in the Tanner 2-3 will have the conditions for entry into the trial and those with menarche or those with diabetes, thyroid disorders, cardiovascular disease or any other disease requiring drug administration will not be included in the trial.
Intervention groups
36 obese/overweight girls 9-11 years old will be randomly assigned into in three homogeneous groups of 12 subjects, in which the intervention group 1 will perform interval aerobic training and the intervention group 2 will perform continuous aerobic training and the control group will not have any exercise program.
Main outcome variables
Energy homeostasis regulating biomarkers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180928041160N1
Registration date:2018-11-06, 1397/08/15
Registration timing:retrospective
Last update:2018-11-06, 1397/08/15
Update count:0
Registration date
2018-11-06, 1397/08/15
Registrant information
Name
Rozita Fathi
Name of organization / entity
University of Mazandaran
Country
Iran (Islamic Republic of)
Phone
+98 11 3530 2201
Email address
r.fathi@umz.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-01-13, 1396/10/23
Actual recruitment start date
2018-01-05, 1396/10/15
Actual recruitment end date
2018-01-13, 1396/10/23
Trial completion date
2018-03-16, 1396/12/25
Scientific title
Study of the Effect of Aerobic Continuous/Interval Training on Levels of Homeostasis Biomarkers in Overweight/Obese Girls
Public title
Effects of exercise training on energy homeostasis
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Overweight/Obese Girls
Tanner Stage 2,3
Exclusion criteria:
The menarche has occurred
Those with cardiovascular disease, diabetes and thyroid disorders
Age
From 9 years old to 11 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
36
Actual sample size reached:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Using random allocation software to generate random sequences, subjects are randomly assigned to one of the three study groups and received intervention from the same group.
Blinding (investigator's opinion)
Single blinded
Blinding description
It is planned in such a way that the participant does not understand which of the two training groups belongs.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Mazandaran
Street address
beheshti Ave, Daneshgah Blvd, University of mazandaran
City
Babolsar
Province
Mazandaran
Postal code
13534 – 47416
Approval date
2018-08-15, 1397/05/24
Ethics committee reference number
IR.UMZ.REC.1397.015
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
spexin
Timepoint
Before the intervention and after 8 weeks of training
Method of measurement
Common Laboratory Kits
2
Description
Angiopoietin-like proteins
Timepoint
Before the intervention and after 8 weeks of training
Method of measurement
Common Laboratory Kits
3
Description
WNT1-inducible-signaling pathway protein 1 (WISP-1)
Timepoint
Before the intervention and after 8 weeks of training
Method of measurement
Common Laboratory Kits
4
Description
Dipeptidyl peptidase-4
Timepoint
Before the intervention and after 8 weeks of training
Method of measurement
Common Laboratory Kits
5
Description
Blood metabolic parameters such as lipid profile, glucose, insulin, and ...
Timepoint
Before the intervention and after 8 weeks of training
Method of measurement
Common Laboratory Kits
6
Description
Amino Acids
Timepoint
Before the intervention and after 8 weeks of training
Method of measurement
High-performance liquid chromatography
Secondary outcomes
1
Description
Anthropometric indices
Timepoint
Before the intervention and after 8 weeks of training
Method of measurement
Measurements of height, weight, waist circumference and subcutaneous fat
Intervention groups
1
Description
Intervention group: Perform Interval training for 8 weeks
Category
Prevention
2
Description
Intervention group: Perform continuous training for 8 weeks
Category
Prevention
3
Description
Control group: Not participate in any training programs
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Babolsar city schools
Full name of responsible person
Masoumeh Baghersalimi
Street address
Shahid kohan Ave, Abualisina school
City
Babolsar
Province
Mazandaran
Postal code
4783161936
Phone
+98 11 4244 7258
Email
baghersalimi.m@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Mazandaran
Full name of responsible person
Elaheh Talebi Garakani
Street address
Beheshti Ave, Daneshgah Blvd, University of Mazandaran
City
Babolsar
Province
Mazandaran
Postal code
13534 – 47416
Phone
+98 11 3530 2201
Email
talebi_umz@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Mazandaran
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
University of Mazandaran
Full name of responsible person
Masoumeh Baghersalimi
Position
PhD Student
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Bheshti Ave, Daneshgah Blvd, University of Mazandaran
City
Babolsar
Province
Mazandaran
Postal code
4783161936
Phone
+98 11 4244 7258
Email
baghersalimi.m@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Mazandaran
Full name of responsible person
Rozita Fathi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Bheshti Ave, Daneshgah Blvd, University of Mazandaran
City
Babolsar
Province
Mazandaran
Postal code
13534 – 47416
Phone
+98 11 3530 2201
Email
roz_fathi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of Mazandaran
Full name of responsible person
Masoumeh Baghersalimi
Position
PhD Student
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Bheshti Ave, Daneshgah Blvd, University of Mazandaran
City
Babolsar
Province
Mazandaran
Postal code
4783161936
Phone
+98 11 4244 7258
Email
baghersalimi.m@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
Information on the main outcome or the like can be shared.
When the data will become available and for how long
Start the access period at least one year after printing the results
To whom data/document is available
Data will only be available to researchers in academia
Under which criteria data/document could be used
The data analysis table will be available
From where data/document is obtainable
Email
What processes are involved for a request to access data/document