Protocol summary

Study aim
the present research aimed to design, implement and evaluate women’s hookah smoking quitting program in Bandar Abbas in the light of the intervention mapping approach
Design
The sampling method will be random. First, four comprehensive health services centers were selected randomly from Bandar Abbas city level and randomly two centers in the intervention group and two centers in the control group.number of samples from each center will be determined according to the population covered by the center.
Settings and conduct
This quasi-experimental study will be conducted on women that consumer hookha in Bandar Abbas. The sampling method will be random. First, four comprehensive health services centers were selected randomly from Bandar Abbas city level and randomly two centers in the intervention group and two centers in the control group . number of samples from each center will be determined according to the population covered by the center.
Participants/Inclusion and exclusion criteria
Hookah consumption 4 times a week for at least 6 months before data collection, reading and writing skills, persion language, lack of history of psychiatric disorders, non-cardiovascular disease, non-pregnancy, residence in Bandar Abbas and Satisfaction is to participate in the study, the exclusion criteria for the study of simultaneous consumption of cigarettes and other tobacco products or drugs and absences are more than 20% of the training sessions
Intervention groups
In accordance with the framework intervention mapping, intervention program identifies during the implementation of the project.
Main outcome variables
cession of hookah, reduce the hookah use

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190126042494N1
Registration date: 2019-03-03, 1397/12/12
Registration timing: prospective

Last update: 2019-03-03, 1397/12/12
Update count: 0
Registration date
2019-03-03, 1397/12/12
Registrant information
Name
teamur aghamolaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 7192
Email address
taghamolaei@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2020-02-18, 1398/11/29
Actual recruitment start date
2019-05-22, 1398/03/01
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, implementation and evaluation of a hookah smoking quitting program among women in Bandar Abbas with an intervention mapping approach
Public title
hookah smoking quitting program among women in Bandar Abbas
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Smoking hookah 4 times a week for at least 6 months prior to data collection Literacyreading and writing, Persian language, No history of psychiatric disorder Lack of cardio-vascular diseases
Exclusion criteria:
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 130
Actual sample size reached: 130
Randomization (investigator's opinion)
Randomized
Randomization description
sampling method will be randomize. First, four comprehensive health services centers were selected randomly from Bandar Abbas city and randomly two centers in the intervention group and two centers in the control group . The number of samples from each center will be determined according to the population covered by the center.
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 Hormozgan University of Medical Sciences
Street address
Hormozgan, Bandar Abbas, Shahid Chamran Boulevard, University of Medical Sciences
City
Bandar Abass
Province
Hormozgan
Postal code
7919766581
Approval date
2018-11-18, 1397/08/27
Ethics committee reference number
IR.HUMS.REC.2018.249

Health conditions studied

1

Description of health condition studied
Hookah smoking
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
cession hookah
Timepoint
base,3,6After intervention
Method of measurement
questionnaire

Secondary outcomes

1

Description
Reducing hookah in women
Timepoint
basis,3,6 month after intervention
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group: Based on the intervention mapping framework, training materials and type of intervention are identified during the implementation of the project. Intervention Mapping has 6 steps. It is based on qualitative research of behavioral and environmental factors affecting the problem in step one to five. Based on the results of the first step, educational interventions will be designed.
Category
Lifestyle

2

Description
Control group: Six months after the intervention in the intervention group, the same interventions are performed in the control group.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
مرکز خدمات جامع سلامت
Full name of responsible person
teamur aghamolaei
Street address
Bolvar chamran, Bandar Abass, university of medical scince
City
Bandar Abass
Province
Hormozgan
Postal code
7919766581
Phone
+98 76 3333 7192
Email
taghamolaei@hums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
teamur aghamolaei
Street address
Bolvar, chamran, Hormozgan university medical of scinse
City
Bandar Abass
Province
Hormozgan
Postal code
7919766581
Phone
+98 76 3333 7192
Email
taghamolaei@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Behbahan University of Medical Sciences
Full name of responsible person
Teamur Aghamolaei
Position
Prof- Teamur Aghamolaei, Social Determinants on Health Promotion Research Center, Hormozgan Universi
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Hormozgan University of Medical Sciences, Kuy e Farhangiyan, Payambar aazam medical educational complex
City
Bandar Abass
Province
Hormozgan
Postal code
7919766581
Phone
+98 76 3333 7192
Fax
Email
taghamolaei@hums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Behbahan University of Medical Sciences
Full name of responsible person
Teamur Aghamolaei
Position
Prof- Teamur Aghamolaei, Social Determinants on Health Promotion Research Center, Hormozgan Universi
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Hormozgan University of Medical Sciences, Kuy e Farhangiyan, Payambar aazam medical educational complex
City
Bandar Abass
Province
Hormozgan
Postal code
7919766581
Phone
+98 76 3333 7192
Fax
Email
taghamolaei@hums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Behbahan University of Medical Sciences
Full name of responsible person
Teamur Aghamolaei
Position
Prof- Teamur Aghamolaei, Social Determinants on Health Promotion Research Center, Hormozgan Universi
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Hormozgan University of Medical Sciences, Kuy e Farhangiyan, Payambar aazam medical educational complex
City
Bandar Abass
Province
Hormozgan
Postal code
7919766581
Phone
+98 76 3333 7192
Fax
Email
taghamolaei@hums.ac.ir

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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
only factors that affect hookah use quit smoking and outcomesWill be share
When the data will become available and for how long
Start of access to information from 2020
To whom data/document is available
All relevant researchers and stakeholders
Under which criteria data/document could be used
Data can only be used to improve the health promotionof women.
From where data/document is obtainable
E-mail to responsible author
What processes are involved for a request to access data/document
Part of the documentation of this protocol can be prepared and available to applicants for at least 1 year
Comments
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