Protocol summary

Study aim
Determining the effect of virtual exercise on self-concept and self-esteem of obese girls
Design
This study includes 7-10-year-old girls suffering from obesity in Khorramabad city, who are divided into two intervention and control groups by a simple random method.
Settings and conduct
By referring to the primary schools of Khorram Abad city, 104 girls with obesity will be selected based on the study entry criteria, and then the samples will be randomly divided into two intervention and control groups.
Participants/Inclusion and exclusion criteria
Entry criteria: being in the age range of 7 to 10 years, interest and motivation to exercise, not having diseases that lead to obesity. Obesity Exclusion criteria: lack of consent of mother and child to participate in the study, lack of interest and motivation to exercise, having diseases that lead to obesity, having pain for any reason in the process of conducting the study, single parenthood, addiction of divorced parents, loss Education in recent years or the presence of neuromuscular disorders and cerebral palsy.
Intervention groups
The intervention includes the implementation of sports exercises based on sports instructions. The sports training protocol (clip recorded by the researcher) includes eight weeks of training. There are three training sessions per week and each session consists of 30 minutes of training. After the intervention, the self-esteem and self-concept questionnaire is filled by the parents. Control group: This group does not do sports exercises.
Main outcome variables
Behavior and self-respect, mental status and school, physical characteristics and appearance, anxiety, popularity Happiness and satisfaction, general self-esteem, social self-esteem, family self-esteem, academic self-esteem

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231103059944N1
Registration date: 2023-11-08, 1402/08/17
Registration timing: prospective

Last update: 2023-11-08, 1402/08/17
Update count: 0
Registration date
2023-11-08, 1402/08/17
Registrant information
Name
Fatemeh Sadeghi
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3272 7617
Email address
fa.sadeghi1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-23, 1402/10/02
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of virtual sports training on self-concept and self-esteem of obese girls
Public title
Investigating the effect of virtual sports training on self-concept and self-esteem of obese girls
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Being in the age range of 7 to 10 years Interest and motivation to exercise Not having diseases that lead to obesity Not mentally retarded Obesity
Exclusion criteria:
Lack of consent of mother and child to participate in the study Lack of interest and motivation to exercise Having diseases that lead to obesity Having pain for any reason during the study implementation process being a single parent Parental addiction divorce Academic decline in recent years Presence of neuromuscular disorders and cerebral palsy
Age
From 7 years old to 10 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 104
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization in order to randomly assign people in two test and control groups
Blinding (investigator's opinion)
Double blinded
Blinding description
The people participating in the study are not aware of which group (intervention or control) they are placed in, and the researcher places the participants in two groups based on a random method.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Khorramabad University of Medical Sciences
Street address
Kamalvand - Khorram Abad University of Medical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2022-04-22, 1401/02/02
Ethics committee reference number
IR-lums.rce.1401.196

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Self-esteem score and self-concept
Timepoint
before the start of the intervention and eight weeks after the intervention
Method of measurement
Pirez Children's Self-Concept Questionnaire and Cooper Smith Self-Esteem Questionnaire

Secondary outcomes

1

Description
The score of behavior and self-respect
Timepoint
before the start of the intervention and eight weeks after the intervention
Method of measurement
Self-concept questionnaire of older children

2

Description
Mental status score and school
Timepoint
before the start of the intervention and eight weeks after the intervention
Method of measurement
Self-concept questionnaire of older children

3

Description
Score of features and physical appearance
Timepoint
before the start of the intervention and eight weeks after the intervention
Method of measurement
Self-concept questionnaire of older children

4

Description
Anxiety score
Timepoint
before the start of the intervention and eight weeks after the intervention
Method of measurement
Self-concept questionnaire of older children

5

Description
Popularity score
Timepoint
before the start of the intervention and eight weeks after the intervention
Method of measurement
Self-concept questionnaire of older children

6

Description
Happiness and satisfaction score
Timepoint
before the start of the intervention and eight weeks after the intervention
Method of measurement
Questionnaire of self-concept of older children

7

Description
overall self-esteem,
Timepoint
before the start of the intervention and eight weeks after the intervention
Method of measurement
Cooper Smith self-esteem questionnaire

8

Description
social self-esteem
Timepoint
before the start of the intervention and eight weeks after the intervention
Method of measurement
Cooper Smith self-esteem questionnaire

9

Description
family self-esteem
Timepoint
before the start of the intervention and eight weeks after the intervention
Method of measurement
Cooper Smith self-esteem questionnaire

10

Description
Academic self-esteem
Timepoint
before the start of the intervention and eight weeks after the intervention
Method of measurement
Cooper Smith self-esteem questionnaire

Intervention groups

1

Description
Control group: This group does not do sports exercises
Category
Lifestyle

2

Description
Intervention group: This group performs sports exercises according to the training video sent by the researcher
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Primary schools for girls in Khorramabad city
Full name of responsible person
Kimia karami
Street address
Primary schools for girls in Khorramabad city
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3372 7084
Email
lorestan .lums@ gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Bahram Rasolian
Street address
Moalem St., Anoushirvan Rezaei Square, Lorestan University of Medical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3272 7084
Email
Rasolian.Bahram@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Lorestan 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Kimia Karami
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Moalem St., Anoushirvan Rezaei Square, Lorestan University of Medical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
066133306698+
Email
pr@lums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Kimia Karmi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Moalem Street, Anoushirvan Rezaei Square, Lorestan University of Medical Sciences
City
Khorramabad
Province
Lorestan
Postal code
681383946
Phone
066133306698+
Email
pr@lums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Kimia Karmi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Moalem St., Anoushirvan Square, Lorestan University of Medical Sciences
City
Khorramabad
Province
Lorestan
Postal code
9813833946
Phone
+98 916 794 9802
Email
pr@lums.ac.ir

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
Yes - There is 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
Title and more details about the data/document
I have not decided yet
When the data will become available and for how long
I have not decided yet
To whom data/document is available
I have not decided yet
Under which criteria data/document could be used
I have not decided yet
From where data/document is obtainable
I have not decided yet
What processes are involved for a request to access data/document
I have not decided yet
Comments
I have not decided yet
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