Protocol summary

Summary
This study is a randomized controlled trial.The aim of this study will be to determine the effect of educational programs designed to reduce hookah smoking among high school male students in Hamadan. Design: in the first stage, using quantitative and qualitative methods, a needs assessment will be to reduce hookah smoking of behavioral problems students.According to the results of the needs assessment, 2 schools with high prevalence of hookah have identified and randomly assigned to experimental and control groups.Blinding the study was done only for students.Setting and conduct: In the intervention stage production of educational material tailored to the culture and characteristics of the target population as well as the intervention stage is based on active learning and the educational intervention to try to ensure that hookah smokers actively in the training program have activities teaching-learning with their contribution to the brand.Exclusion Criteria:to use of tobacco in the last month, High Schools Male Students ( ninth, tenth and eleventh grade).Outcome measure:assess will be for effectiveness of interventions related between the intervention and control groups for determine expected outcomes in two three periods before,immediately and three months after intervention.The primary outcome is the reduction of hookah smoking among students.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017042333592N1
Registration date: 2017-05-14, 1396/02/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-05-14, 1396/02/24
Registrant information
Name
Hamid Abasi
Name of organization / entity
Hamadan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3254 9481
Email address
h.abasi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan university of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-04-20, 1397/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Educational Program Based on Theory to reduce hookah smoking among High Schools Male Students in Hamadan City: Exploratory Mixed Method Design
Public title
The effects of intervention program to reduce hookah smoking among students
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: to use of tobacco in the last month, High Schools Male Students ( ninth, tenth and eleventh grade), lack of physical or mental illness and the participants and their parents are happy to participate in the intervention. Exclusion criteria for this study include the absence of training sessions for participants twice as well when completing the questionnaire, immediately and 3 months after the training program are not available.
Age
From 14 years old to 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 the Hamadan University of Medical Science
Street address
Martyr Fahmideh Street, Hamadan University of Medical Science
City
Hamadan
Postal code
6517838736
Approval date
2017-04-08, 1396/01/19
Ethics committee reference number
IR.UMSHA.REC.1396.21

Health conditions studied

1

Description of health condition studied
Nicotine Dependence
ICD-10 code
F17.2
ICD-10 code description
Dependence- due to - toobaco

Primary outcomes

1

Description
Frequency of Water pipe smoking use
Timepoint
Before the Study, Immediately after intervention and 3 Months after the intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Constructs of combined health education and health promotion model
Timepoint
Before study, Immediately the intervention and Three Months after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention for the intervention group consisted of: Perform educational program during two sessions, distribute educational booklet, Follow-up and evaluation for 2 months to reduce the use of Water Pipe smoking and completing the questionnaire before intervention, Immediately after intervention and 3 months after intervention.
Category
Behavior

2

Description
Intervention in the control group: The control group did not receive. Contemporary, the experimental group completed the questionnaire 3 times.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
The first and second grades high schools male
Full name of responsible person
Hamid Abasi
Street address
Hamadan University of Medical Science
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice- Chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Vice- Chancellor of Research and Technology, Hamadan University of Medical Sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice- Chancellor of Research and Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Hamadan University of Medical Science
Full name of responsible person
Hamid Abasi
Position
PhD Student of Health Education and Health Promotion
Other areas of specialty/work
Street address
Martyr Fahmideh Street, Hamadan University of Medical Science
City
Hamadan
Postal code
Phone
+98 812549481
Fax
Email
h.abasi@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Science
Full name of responsible person
Hamid Abasi
Position
PhD Student of Health Education and Health Promotion
Other areas of specialty/work
Street address
Martyr Fahmideh Street, Hamadan University of Medical Science
City
Hamadan
Postal code
Phone
+98 812549481
Fax
Email
h.abasi@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Science
Full name of responsible person
Hamid Abasi
Position
PhD Student of Health Education and Health Promotion
Other areas of specialty/work
Street address
Martyr Fahmideh Street, Hamadan University of Medical Science
City
Hamadan
Postal code
Phone
+98 812549467
Fax
Email
h.abasi@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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