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Smoking Interventions in the General Population

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ClinicalTrials.gov Identifier: NCT00678938
Recruitment Status : Unknown
Verified May 2008 by University Medicine Greifswald.
Recruitment status was:  Active, not recruiting
First Posted : May 16, 2008
Last Update Posted : May 16, 2008
Sponsor:
Information provided by:
University Medicine Greifswald

Brief Summary:
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 or disease Intervention/treatment Phase
Tobacco Smoking Behavioral: Smoking abstinence oriented expert system intervention Behavioral: Smoking reduction oriented expert system intervention Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1462 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: General Population Based Interventions for Smokers Not Ready to Quit: Testing Smoking Reduction vs. Abstinence Oriented Computer Expert Systems
Study Start Date : October 2004
Estimated Primary Completion Date : October 2008
Estimated Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Point prevalence of tobacco abstinence [ Time Frame: 24 hours, 7 days, 4 weeks, 6 months preceeding the 12 and 24 month follow-up assessments ]

Secondary Outcome Measures :
  1. number of Cigarettes smoked per day [ Time Frame: 4 weeks preceeding follow-up assessment ]
  2. number of quit and cutdown attempts [ Time Frame: last 12 months preceeding follow-up assessment ]
  3. Stages of change progress [ Time Frame: at 12 and 24 months follow-up ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678938


Sponsors and Collaborators
University Medicine 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

Responsible Party: Christian Meyer, Dr. (principal investigator) / Anja Schumann, Dr. (co-investigator) / Ulrich John, Prof. Dr. (study director), Ernst-Moritz-Arndt-University of Greifswald, Institute of Epidemiology and Social Medicine
ClinicalTrials.gov Identifier: NCT00678938     History of Changes
Other Study ID Numbers: E2_P5, 01EB0420
First Posted: May 16, 2008    Key Record Dates
Last Update Posted: May 16, 2008
Last Verified: May 2008

Keywords provided by University Medicine Greifswald:
smoking reduction
smoking cessation
stages of change
expert system interventions