Protocol summary

Study aim
Determining the effectiveness of Community- Based Intervention based on Protection Motivation Theory on prevention hookah smoking among youth and adolescences aged 12-24 years in Sirjan
Design
1- One group is evaluated in this training pre and post test. 2- random sampling is done by lottery from family health documents. 3. The educational strategy in this study is an educational campaign. 4- 180 people are followed up for three months, from March 2018 to June 2018. 5- After three months, the effect of educational intervention will be examined.
Settings and conduct
Young people aged 12-24 years living in Sirjan, which is located in the southeast of Iran, are participated in this study. This study is a type of educational intervention which is evaluated in pre and post test. Two health centers were randomly selected and then eligible individuals were randomly selected (by lottery method) and have been entered into study. (There is no control group in training campaigns).
Participants/Inclusion and exclusion criteria
Inclusion criteria: No addiction and Resident in Sirjan city within the next 5 months Exclusion criteria: unwilling to participate in the study.
Intervention groups
Adolescences and young people (Ages 12 – 24 years)
Main outcome variables
Increase in knowledge, attitude and practice regarding the prevention of hookah smoking

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140518017734N3
Registration date: 2018-04-21, 1397/02/01
Registration timing: registered_while_recruiting

Last update: 2018-04-21, 1397/02/01
Update count: 0
Registration date
2018-04-21, 1397/02/01
Registrant information
Name
Reza Sadeghi
Name of organization / entity
Sirjan Health Department , Kerman University of Medical Sciences.
Country
Iran (Islamic Republic of)
Phone
+98 34 5422 4339
Email address
reza.sadeghi351@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-10, 1396/12/19
Expected recruitment end date
2018-06-09, 1397/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Community- Based Intervention based on Protection Motivation Theory on prevention hookah smoking among youth aged 12-24 years
Public title
Effectiveness of Community- Based Intervention on prevention hookah smoking among youth
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
No addiction Resident of Sirjan city during the next 5 months
Exclusion criteria:
unwillingness to participate in the study
Age
From 12 years old to 24 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 180
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Yazd University of Medical Sciences
Street address
No 12, Shohadaye Gomnam Ave, after Alem Square, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2017-12-19, 1396/09/28
Ethics committee reference number
IR.SSU.SDH.REC.1396.134

Health conditions studied

1

Description of health condition studied
Smoking (hookah smoking)
ICD-10 code
X09
ICD-10 code description
smoke inhalation NOS

Primary outcomes

1

Description
Intention of hook smoking
Timepoint
Before the intervention, and 3 months after intervention
Method of measurement
Standardized questionnaire

Secondary outcomes

1

Description
The rate of hookah consumption in parks
Timepoint
Before the intervention, and 1year after intervention
Method of measurement
check list

Intervention groups

1

Description
Intervention group: Educational campaign to prevent hookah smoking
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Sirjan Health Center
Full name of responsible person
Reza Sadeghi
Street address
No 21, 4th St (Alley), Takhti St, Sirjan
City
Sirjan
Province
Kerman
Postal code
76169-13555
Phone
+98 34 4227 3410
Email
reza.sadeghi351@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Amin Salehi
Street address
No 12, Shohadaye Gomnam Ave, after Alem Square, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3724 9333
Email
amin_nutrition@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Reza Sadeghi
Position
Ph.D. Candidate of health education and health promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
No 12, Shohadaye Gomnam Ave, after Alem Square, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9138
Email
reza.sadeghi351@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed Saeed Mazloomi Mahmood Abad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
No 12, Shohadaye Gomnam Ave, after Alem Square, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9138
Email
mazloomy.mm@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Reza Sadeghi
Position
Ph.D Candidate in Health Education and Health Promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
No 12, Shohadaye Gomnam Ave, After Alem Square, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9138
Email
reza.sadeghi351@yahoo.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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data will be collected in the form of a questionnaire
When the data will become available and for how long
After the intervention
To whom data/document is available
Just execute the plan
Under which criteria data/document could be used
In order to use the results and to generalize it to other communities
From where data/document is obtainable
Research Deputy of Sirjan School of Medical Sciences
What processes are involved for a request to access data/document
First select people and then complete the questionnaire
Comments
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