Smoking Interventions in the General Population

May 14, 2008 updated by: University Medicine Greifswald

General Population Based Interventions for Smokers Not Ready to Quit: Testing Smoking Reduction vs. Abstinence Oriented Computer Expert Systems

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1462

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Point prevalence of tobacco abstinence
Time Frame: 24 hours, 7 days, 4 weeks, 6 months preceeding the 12 and 24 month follow-up assessments
24 hours, 7 days, 4 weeks, 6 months preceeding the 12 and 24 month follow-up assessments

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Anticipated)

October 1, 2008

Study Completion (Anticipated)

October 1, 2008

Study Registration Dates

First Submitted

May 14, 2008

First Submitted That Met QC Criteria

May 14, 2008

First Posted (Estimate)

May 16, 2008

Study Record Updates

Last Update Posted (Estimate)

May 16, 2008

Last Update Submitted That Met QC Criteria

May 14, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E2_P5, 01EB0420

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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