Protocol summary

Study aim
Determining the effect of self-care education in the field of healthy nutrition, physical activity and high risk behavior on the level of knowledge and attitude of adolescent girls in third Grade of first high school in Isfahan 1396
Design
An interventional study with a control group, randomized cluster sampling and a sample size of 200 people
Settings and conduct
We randomly selected two districts 1 and 4 from Isfahan's six districts and randomly selected district 4 as the intervention group and district 1 as the control group. Then, from among 16 schools in district 1 , the Asieh school was randomly selected and shafieiyoon school from among the 31 schools in the district 4 .First The intervention group completed the pre-test and then They participate four sessions on healthy eating, physical activity, smoking, and AIDS, and one month after the last session they complete post-test. control group does not receive training and only complete the pre-test and post-test. By comparing the scores before and after the intervention and comparing the two groups, using the statistical methods, the effectiveness of the training is measured.
Participants/Inclusion and exclusion criteria
Students will be willing to collaborate and sign written informed consent form. Students will be the third grade of first high school student. Between the ages of 14 to16.
Intervention groups
The intervention group, after completing the pre-test, participates in four educational sessions and completes the post-test one month later.And the control group does not receive training and only complete the pre-test and post-test.
Main outcome variables
Healthy Nutrition Knowledge Score: Healthy Nutritional Attitude Score; Physical Activity Knowledge Score; Physical Activity Attitude Score: Prevention of Smoking Knowledge Score: Prevention of Smoking Attitude Score: Knowledge Score for AIDS: Attitude Score of AIDS

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180411039270N1
Registration date: 2018-04-27, 1397/02/07
Registration timing: prospective

Last update: 2018-04-27, 1397/02/07
Update count: 0
Registration date
2018-04-27, 1397/02/07
Registrant information
Name
Azar Nematolahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3633 3128
Email address
stud1290719829@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-30, 1397/02/10
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Self-care education in the field of Healthy Nutrition, Physical Activity and High Risk Behavior on the level of knowledge and attitude of adolescent girls in Third Grade of First high school in Isfahan 1396
Public title
The effect of Self-care education in the field of Healthy Nutrition, Physical Activity and High Risk Behavior on the level of knowledge and attitude of adolescent girls
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Students will be willing to collaborate and sign a written informed consent form students to be girls in Third Grade of First high school Between the ages of 14 to 16 years
Exclusion criteria:
Students who are other than grade nine Students from other schools other than the two selected schools
Age
From 14 years old to 16 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Using multistage cluster randomization method, we selected by drawing, two districts from six education districts(1 , 4) in Isfahan and then selected by drawing, district 1 as the control group and district 4 as the intervention group .then selected by drawing, one school from each district.
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 Shiraz University of Medical Sciences
Street address
No 60 ,Zand street, Shiraz University of Medical Sciences,Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Approval date
2018-02-25, 1396/12/06
Ethics committee reference number
IR.SUMS.REC.1396.179

Health conditions studied

1

Description of health condition studied
Self-care education for adolescent
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Healthy Nutrition Knowledge Score
Timepoint
Before intervention thirty days after intervention
Method of measurement
Questionnaire

2

Description
Healthy Nutritional Attitude Score
Timepoint
Before intervention thirty days after intervention
Method of measurement
Questionnaire

3

Description
Physical Activity Knowledge Score
Timepoint
Before intervention thirty days after intervention
Method of measurement
Questionnaire

4

Description
- Physical Activity Attitude score
Timepoint
Before intervention thirty days after intervention
Method of measurement
Questionnaire

5

Description
Prevention of smoking Knowledge Score
Timepoint
Before intervention thirty days after intervention
Method of measurement
Questionnaire

6

Description
Prevention of smoking Attitude score
Timepoint
Before intervention thirty days after intervention
Method of measurement
Questionnaire

7

Description
Knowledge score about AIDS
Timepoint
Before intervention thirty days after intervention
Method of measurement
Questionnaire

8

Description
Attitude Score for AIDS
Timepoint
Before intervention thirty days after intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:after completing the pre-test, participates in four 45-minute training sessions, entitled Healthy Nutrition, Physical Activity, Smoking Prevention, AIDS Prevention, and Each person receives, in addition to direct training, an educational brochure related to the topic, and completes the post-test one month later
Category
Lifestyle

2

Description
Control group: Complete pre-test and then one month later post-test
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Asie High School
Full name of responsible person
Nematolahi AZAR
Street address
jahad streat, esfahan, iran
City
Esfahan
Province
Isfehan
Postal code
8183914649
Phone
+98 31 3233 8791
Email
stud1290719829@sums.ac.ir

2

Recruitment center
Name of recruitment center
Shafieiyoon high school
Full name of responsible person
Nematolahi Azar
Street address
Dardasht streat, Ibn Sina streat
City
Esfahan
Province
Isfehan
Postal code
8148837362
Phone
+98 31 3446 4073
Email
stud1290719829@sums.ac.ir
Web page address
http://shafieiyoon.blogfa.com/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
آدرس خیابان No 60 ,Zand Street, Shiraz University of Medical Sciences,Shiraz,Iran
City
shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3230 5410
Fax
+98 71 3235 9317
Email
hashemib@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Nematolahi Azar
Position
Master's degree in Midwifery, Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
أNo 73,School of Nursing and Midwifery,Nemazee squair, Shiraz, Iran
City
Sاiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71036474254
Fax
+98 71 3647 4252
Email
nematolah@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nematolahi Azar
Position
Master's degree in Midwifery, Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No 73,School of Nursing and Midwifery,Nemazee squair, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
nematolah@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Department of midwifery ,School of Nursing and Midwifery,Shiraz University of Medical Scientes
Full name of responsible person
Nematolahi Azar
Position
Master's degree in Midwifery, Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No 73,School of Nursing and Midwifery,Nemazee squair, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
nematolah@sums.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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
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
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