Overview

This trial is active, not recruiting.

Condition tobacco smoking
Treatments smoking abstinence oriented expert system intervention, smoking reduction oriented expert system intervention
Phase phase 2
Sponsor University Medicine Greifswald
Start date October 2004
End date October 2008
Trial size 1462 participants
Trial identifier NCT00678938, E2_P5, 01EB0420

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
smoking abstinence oriented expert system intervention
Participants received up to three counselling letters targeting smoking cessation
(Experimental)
smoking reduction oriented expert system intervention
Participants received up to three counselling letters targeting smoking reduction
(No Intervention)

Primary Outcomes

Measure
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 Outcomes

Measure
number of Cigarettes smoked per day
time frame: 4 weeks preceeding follow-up assessment
number of quit and cutdown attempts
time frame: last 12 months preceeding follow-up assessment
Stages of change progress
time frame: at 12 and 24 months follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title General Population Based Interventions for Smokers Not Ready to Quit: Testing Smoking Reduction vs. Abstinence Oriented Computer Expert Systems
Principal investigator Christian Meyer, Dr.
Trial information was received from ClinicalTrials.gov and was last updated in May 2008.
Information provided to ClinicalTrials.gov by University Medicine Greifswald.