Smoking Interventions in the General Population - Full Text View

Sponsored by:	Ernst Moritz Arndt University of Greifswald
Information provided by:	Ernst Moritz Arndt University of Greifswald
ClinicalTrials.gov Identifier:	NCT00678938

Purpose

The study takes up two problems: 1) Little research exists about general population interventions for smokers not ready to quit within the foreseeable future. 2) There is little evidence for smoking reduction as a behavioural goal in interventions. Interventions based on the Transtheoretical Model of Behavior Change (TTM) using computer expert-system technology yield delayed and smaller effects in smokers in the precontemplation stage of change compared to smokers in more advanced stages of change. Reducing the number of cigarettes smoked per day is currently discussed as an intermediate goal for this subgroup. Epidemiological and clinical studies revealed that smokers are able to maintain a substantial reduction. No undermining effects with respect to smoking cessation have been found. However, there are no studies that test the efficacy of behavioural interventions for smoking reduction using population based recruitment. Objectives: Testing the efficacy of TTM based interventions for general population smokers not intending to quit smoking, i.e. a smoking-reduction and a smoking-cessation tailored intervention using computerized expert-system technology.

Condition	Intervention	Phase
Tobacco Smoking	Behavioral: Smoking abstinence oriented expert system intervention Behavioral: Smoking reduction oriented expert system intervention	Phase II

MedlinePlus related topics: Quitting Smoking Smoking

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	General Population Based Interventions for Smokers Not Ready to Quit: Testing Smoking Reduction vs. Abstinence Oriented Computer Expert Systems

Further study details as provided by Ernst Moritz Arndt University of Greifswald:

Primary Outcome Measures:

Point prevalence of tobacco abstinence [ Time Frame: 24 hours, 7 days, 4 weeks, 6 months preceeding the 12 and 24 month follow-up assessments ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

number of Cigarettes smoked per day [ Time Frame: 4 weeks preceeding follow-up assessment ] [ Designated as safety issue: No ]
number of quit and cutdown attempts [ Time Frame: last 12 months preceeding follow-up assessment ] [ Designated as safety issue: No ]
Stages of change progress [ Time Frame: at 12 and 24 months follow-up ] [ Designated as safety issue: No ]

Enrollment:	1462
Study Start Date:	October 2004
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Behavioral: Smoking abstinence oriented expert system intervention Participants received up to three counselling letters targeting smoking cessation
2: Experimental	Behavioral: Smoking reduction oriented expert system intervention Participants received up to three counselling letters targeting smoking reduction
3: No Intervention

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Daily smoking of 10 or more cigarettes
No intention to quit within the next six month
Age of 18 years and older
valid telephone number

Exclusion Criteria:

- Insufficient german language and cognitive capabilities to complete the assessment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678938

Sponsors and Collaborators

Ernst Moritz Arndt University of Greifswald

Investigators

Principal Investigator:	Christian Meyer, Dr.	Ernst-Moritz-Arndt-University of Greifswald, Institute of Epidemiology and Social Medicine
Study Director:	Ulrich John, Prof. Dr.	Ernst-Moritz-Arndt-University of Greifswald, Institute of Epidemiology and Social Medicine

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Ernst-Moritz-Arndt-University of Greifswald, Institute of Epidemiology and Social Medicine ( Christian Meyer, Dr. (principal investigator) / Anja Schumann, Dr. (co-investigator) / Ulrich John, Prof. Dr. (study director) )
Study ID Numbers:	E2_P5, 01EB0420
Study First Received:	May 14, 2008
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00678938
Health Authority:	Germany: Federal German Ministry of Education and Research

Keywords provided by Ernst Moritz Arndt University of Greifswald:

smoking reduction
smoking cessation
stages of change
expert system interventions

Study placed in the following topic categories:

Smoking

Additional relevant MeSH terms:

Habits

ClinicalTrials.gov processed this record on February 06, 2009