Protocol summary

Summary
The aim of this study is to determine effect of education based on Health Belief Model (HBM) by Health Volunteers on Water pipe smoking use among consumer women in Bushehr. Inclusion Criteria indeed Water pipe Smoking for at Least one year, being able to read and write and living in the City of Bushehr. Exclusion Criteria indeed is unwillingness to continue cooperation. This clinical Trial study performed in 127 Water pipe consumer women (63 consumers in intervention group and 64 consumers in control group).The sampling method way that after determining the health care centers with health volunteers are active, 2 centers randomly divided to experimental and control groups.The questionnaire contained questions of demographic, knowledge, health belief model structures, nicotine dependence and consumption of the water pipe smoking. The validity and reliability of questionnaire was confirmed before study. Questionnaire based on HBM constructs containing sections. At first intervention group completed the questionnaire then receive two sessions education based on HBM by health volunteers, and then follow up weekly for two Months. After three months, the third questionnaire completed. Control group received only this sequence of action to complete the questionnaire, they didn’t receive any education .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015022821265N1
Registration date: 2016-04-06, 1395/01/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-06, 1395/01/18
Registrant information
Name
Ahmad Sotoudeh
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 3354 3617
Email address
a.sotudeh@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2015-06-05, 1394/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Education Based on Health Belief Model by Health Volunteers in Reducing on Water pipe Smoking use in Women
Public title
Effect of education Health Volunteers Based on Health Belief Model on Water pipe smoking use in Women
Purpose
Other
Inclusion/Exclusion criteria
inclusion Criteria: Water pipe Smoking for at Least one year Living in the Bushehr city, Being able to read and write, Fill the testimonial form to Participate in the Study Interested in Participating in the Study, Exclusion Criteria: Unwillingness to Continue Cooperation
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 127
Randomization (investigator's opinion)
Randomized
Randomization description
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
Bushehr University of Medical Sciences
Street address
Research Department, Pardis Site, Bushehr University of Medical Sciences, Salman Farsi Street, Bahmani, Bushehr, Iran
City
Bushehr
Postal code
Approval date
2015-01-19, 1393/10/29
Ethics committee reference number
B-93-16-14

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, Week after intervention and 3 Months after the intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Demographic Variables, Kknowledge and Constructs Health Belief Model
Timepoint
Before study, a week after 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, a week after intervention and 3 months after intervention.
Category
Lifestyle

2

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

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghods Health Centers
Full name of responsible person
Leila Svamry
Street address
Ghods Health Centers, Emamzadeh Sector, Sr 22 Mehre, Bushehr, Iran
City
Bushehr

2

Recruitment center
Name of recruitment center
Ali Ibn Abi Talib Health Centers
Full name of responsible person
Sodabe Zalpoor
Street address
Ali Ibn Abi Talib Health Centers, Kooti Sector, Sr Coastal, Bushehr, Iran
City
Bushehr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr Afshin Ostevar
Street address
Research Department, Pardis ْSite, Bushehr University of Medical Sciences, Salman Farsi Street, Bahmani, Bushehr, Iran
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bushehr 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
Bushehr University of Medical Sciences
Full name of responsible person
Dr Azita Noroozi
Position
Dr Health Education and Health Promotion
Other areas of specialty/work
Street address
Faculty of Health , Pardis Site, Bushehr University of Medical Sciences, Salman Farsi Street, Bahmani, Bushehr, Iran
City
Bushehr
Postal code
Phone
+98 77 3455 0089
Fax
Email
azitanoroozi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr Azita Noroozi
Position
Dr Health Education and Health Promotion
Other areas of specialty/work
Street address
Faculty of Health, Pardis Site, Bushehr University of Medical Sciences, Salman Farsi Street, Bahmani, Bushehr, Iran
City
Bushehr
Postal code
Phone
+98 77 3455 0089
Fax
Email
azitanoroozi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Ahmad Setoudeh
Position
Msc Student of Health Education
Other areas of specialty/work
Street address
Faculty of Healthْ, Pardis Site, Bushehr University of Medical Sciences, Salman Farsi Street, Bahmani, Bushehr, Iran
City
Bushehr
Postal code
Phone
Fax
Email
a.sotudeh@bpums.ac.irahmad_sotudeh@yahoo.com
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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