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Smoking Interventions in the General Population

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by University Medicine Greifswald.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT00678938
First received: May 14, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medicine 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
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

  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
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
  More Information

No publications provided

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
Study First Received: May 14, 2008
Last Updated: May 14, 2008
Health Authority: Germany: Federal German Ministry of Education and Research

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

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 16, 2013