Smoking Interventions in the General Population

NCT00678938 | Unknown Phase 2 DMC

• 1 other identifier: E2_P5, 01EB0420
• Study Type: interventional
• Target: 1,462
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tobacco Smoking

Keywords

smoking reduction; smoking cessation; stages of change; expert system interventions

Outcome Measures

Primary Outcomes (1)

• Point prevalence of tobacco abstinence

  24 hours, 7 days, 4 weeks, 6 months preceeding the 12 and 24 month follow-up assessments

Secondary Outcomes (3)

• number of Cigarettes smoked per day

  4 weeks preceeding follow-up assessment

• number of quit and cutdown attempts

  last 12 months preceeding follow-up assessment

• Stages of change progress

  at 12 and 24 months follow-up

Study Arms (3)

1

EXPERIMENTAL

Behavioral: Smoking abstinence oriented expert system intervention

2

EXPERIMENTAL

Behavioral: Smoking reduction oriented expert system intervention

3

NO INTERVENTION

Interventions

Smoking abstinence oriented expert system intervention BEHAVIORAL

Participants received up to three counselling letters targeting smoking cessation

1

Smoking reduction oriented expert system intervention BEHAVIORAL

Participants received up to three counselling letters targeting smoking reduction

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Insufficient german language and cognitive capabilities to complete the assessment

Sponsors & Collaborators

• University Medicine Greifswald: lead

MeSH Terms

Conditions

Tobacco Smoking; Smoking Reduction; Smoking Cessation

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use; Health Behavior

Study Officials

• Christian Meyer, Dr.

  Ernst-Moritz-Arndt-University of Greifswald, Institute of Epidemiology and Social Medicine

  PRINCIPAL INVESTIGATOR

• Ulrich John, Prof. Dr.

  Ernst-Moritz-Arndt-University of Greifswald, Institute of Epidemiology and Social Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 16, 2008
• Study Start: October 1, 2004
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: May 16, 2008

Record last verified: 2008-05