Objective:The Effect of Individualized Counseling, Phone Line Follow up, and Nicotine Chewing Gum on Smoking Cessation in Smokers.
Design: A clinical trial, pre and post test design with randomized control group.
Setting and Conduct: The study population is all Gorgan city smokers recruited through sending of short message system (sms). Then,they randomly were allocated to control and treatment groups.
Participants:Smokers are in preparation stage of smoking behavior. The inclusion criteria are readiness to quit; age between 12-80 years old; not to be Pregnant; and not suffer from MI or CVA in last 3 weeks. There is no limitation for exclusion.
Interventions: Five sessions of personally counseling that will take about 45 minutes .Using nicotine chewing gum for 2 months along with phone line follow up including two times in first week of the nicotine chewing gum using.Then once a week till three months and finally quarterly untill the end of sixth months.
Main outcomes: It is expected smoking cessation for at least six month after intervetion begining.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011025074N1
Registration date:2012-06-05, 1391/03/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-05, 1391/03/16
Registrant information
Name
Abdurrhman Charkazi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1235 6120
Email address
charkazi@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2011-07-16, 1390/04/25
Expected recruitment end date
2011-10-17, 1390/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Individualized Counseling, Phone Line Follow up, and Nicotine chewing Gum on Smoking Cessation in Smokers: A clinical Trial Study
Public title
The Effect of Individualized Counseling, Phone Line Follow up, and Nicotine Chewing Gum on Smoking Cessation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Appeasing in preparation stage of smoking behavior; being in readiness to quit; age between 12-80 years old; not to be pregnant; and suffer from MI or CVA in last 3 weeks.
Exclusion criteria: There is no limitation for the participants exclusion.
Age
From 12 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
112
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
Ethics Committe of Isfahan University of Medical Sciences
Street address
No 4 Building, Vice Chancellor for Research, Isfahan University of Medical Sciences, Hezar Jarib Ave, Isfahan , Iran.
City
Isfahan
Postal code
Approval date
2011-07-16, 1390/04/25
Ethics committee reference number
390076
Health conditions studied
1
Description of health condition studied
smoking cessation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
smoking cessation stability
Timepoint
baseline, 3 and 6 months after intervention
Method of measurement
Fagerstrom test, Diclemente and et al. Stages of change questionnaire
Secondary outcomes
1
Description
Relapse in smoking cessation
Timepoint
Baseline, 3 and 6 months after intervention
Method of measurement
Self reporting
Intervention groups
1
Description
Two milligrams of nicotine chewing gum will used based on subjects nicotine dependency for 2 months, five consulting sessions along with one booklet.
The using dose of nicotine gum is basis on the subjects nicotine dependency that will divided in 3 groups: low dependency group (score1 - 4 ) according to Fagerstrum test), middle dependency(score 5-7), high dependency (8-10). Low, middle, and high depended people will receive the maximum daily gums by 6, 9, and 12 gums, respectively. For all three groups nicotine chewing gum doses will tapered 2 gums biweekly.
Category
Treatment - Drugs
2
Description
Control group will not received any drug or intervention except recommendation for cessation.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
No 6 Health Center, 1 st Mordad Alley, 32 nd Edalat Street, Gorgan, Iran.
Full name of responsible person
Abdurrahman Charkazi
Street address
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Doctor Mehdi Amin
Street address
No 4 Building, Vice Chancellor for Research, Isfahan University of Medical Sciences, Hezar Jarib Ave, Isfahan, Iran.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences, Vice Chancellor for Research
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
Isfahan University of Medical Sciences
Full name of responsible person
Abdurrahman Charkazi
Position
Ph D Candidate in Health Education
Other areas of specialty/work
Street address
Department of Health Education and Health Promotion, School of Health, Isfahan University of Medical Sciences, Hezarjarib Ave, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 983117922684
Fax
Email
charkazi@hlth.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Doctor Gholamreza Sharifirad
Position
Professor
Other areas of specialty/work
Street address
Department of Health Education and Health Promotion, School of Health, Isfahan University of Medical Sciences, Hezarjarib Ave, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 98317922910
Fax
Email
sharifirad@hlth.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Abdurrahman Charkazi
Position
Ph D candidate in Health Education
Other areas of specialty/work
Street address
Departmant of Health Education and Health Promotion, School of Health, Isfahan University of Medical Sciences, Hezarjarib Ave, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 981712356120
Fax
Email
charkazi@hlth.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)