Comparison of Four Different Smoking Cessation Programmes

NCT ID: NCT01487642

Last Updated: 2011-12-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-11-30

Brief Summary

The primary objective of the study is to compare the efficacy of four different smoking cessation programmes, including a proactive telephone counseling intervention, a reactive telephone counseling a and an interactive web-based intervention and (as control) written self-help material.

Detailed Description

Smoking remains the most important threat to public health. The majority of smokers wish to quit smoking and every year a substantial part of smokers makes a quit attempt. However, the majority of smokers tries to quit unassisted and existing smoking cessation interventions are underused. In this study we test the effectiveness of four different smoking cessation interventions in a randomized controlled trial. The study provides knowledge on factors important for recruitment and gives indication on potential reach of interventions among the general population. This knowledge can help us in designing interventions that is both effective but also have a high reach in the general population.

Conditions

Smoking; Smoking Cessation; Self-efficacy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Telephone counselling

Group Type: EXPERIMENTAL

Standard 15-minute telephone counselling

Intervention Type: DEVICE

Subjects in arm 1 will benefit from a standard 15-minute telephone counselling session with a professional adviser which resembles a normal call to the national Quit-line. The telephone counselling will be reactive, thus the smoker initiates the call to a designated number to receive advice and information based on the needs and wishes of this particular smoker. Participants can receive self-help materials and information on other smoking cessation services if they wish.

Proactive telephone counselling

Intervention Type: DEVICE

subjects in arm 2 will benefit from of five 15-minute calls from a professional adviser. Similar to the standard reactive telephone counselling, the proactive counselling will be a personal discussion and advice based on the needs and wishes of the particular participant. Together, the participant and adviser will determine a cessation date and schedule one call 3-7 days before the cessation date, one call immediately after the cessation date and three additional calls on days 3, 10 and 24, respectively, post-cessation.

Proactive telephone counselling

Group Type: EXPERIMENTAL

Proactive telephone counselling

Intervention Type: DEVICE

subjects in arm 2 will benefit from of five 15-minute calls from a professional adviser. Similar to the standard reactive telephone counselling, the proactive counselling will be a personal discussion and advice based on the needs and wishes of the particular participant. Together, the participant and adviser will determine a cessation date and schedule one call 3-7 days before the cessation date, one call immediately after the cessation date and three additional calls on days 3, 10 and 24, respectively, post-cessation.

web-based smoking cessation programme

Group Type: EXPERIMENTAL

Interactive web-based smoking cessation programme

Intervention Type: DEVICE

Subjects in arm 3 will benefit from a tailored and interactive web-based smoking cessation programme. Besides interactive and personalised information generated on the webpage, the participant will receive by e-mail and SMS tailored feedback messages based on the particular profile of the participant on particular dates as well as topics during the cessation period depending on how well the cessation is proceeding.

Self-help material

Group Type: ACTIVE_COMPARATOR

Self-help material

Intervention Type: DEVICE

Participants receives self-help materials and on request information on other smoking cessation services if they wish.

Interventions

Standard 15-minute telephone counselling

Subjects in arm 1 will benefit from a standard 15-minute telephone counselling session with a professional adviser which resembles a normal call to the national Quit-line. The telephone counselling will be reactive, thus the smoker initiates the call to a designated number to receive advice and information based on the needs and wishes of this particular smoker. Participants can receive self-help materials and information on other smoking cessation services if they wish.

Intervention Type: DEVICE

Proactive telephone counselling

subjects in arm 2 will benefit from of five 15-minute calls from a professional adviser. Similar to the standard reactive telephone counselling, the proactive counselling will be a personal discussion and advice based on the needs and wishes of the particular participant. Together, the participant and adviser will determine a cessation date and schedule one call 3-7 days before the cessation date, one call immediately after the cessation date and three additional calls on days 3, 10 and 24, respectively, post-cessation.

Intervention Type: DEVICE

Interactive web-based smoking cessation programme

Subjects in arm 3 will benefit from a tailored and interactive web-based smoking cessation programme. Besides interactive and personalised information generated on the webpage, the participant will receive by e-mail and SMS tailored feedback messages based on the particular profile of the participant on particular dates as well as topics during the cessation period depending on how well the cessation is proceeding.

Intervention Type: DEVICE

Self-help material

Participants receives self-help materials and on request information on other smoking cessation services if they wish.

Intervention Type: DEVICE

Other Intervention Names

Stoplinien.dk; Stoplinien.dk; ddsp.dk; stoplinien.dk

Eligibility Criteria

Inclusion Criteria

• Aged 16 and older
• Current smoker: Willing to quit smoking within the next 12 weeks
• Having a regular access to Internet
• Having a personal e-mail address
• Having a personal mobile cell phone with a Danish number
• Given informed consent
• Can read and understand Danish

Exclusion Criteria

• Less than 16 years of age
• No personal e-mail address
• No personal mobile cell phone
• Not able to give informed consent

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Danish Cancer Society

OTHER

Sponsor Role: collaborator

National Board of Health, Denmark

OTHER_GOV

Sponsor Role: collaborator

University of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Peter Dalum

Primary investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Dalum, Ph.d

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Locations

National institute of Public Health, University of Southern Denmark

Copenhagen, , Denmark

Countries

Denmark

References

Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

Reference Type: DERIVED

PMID: 39868569 (View on PubMed)

Skov-Ettrup LS, Dalum P, Bech M, Tolstrup JS. The effectiveness of telephone counselling and internet- and text-message-based support for smoking cessation: results from a randomized controlled trial. Addiction. 2016 Jul;111(7):1257-66. doi: 10.1111/add.13302. Epub 2016 Apr 13.

Reference Type: DERIVED

PMID: 26748541 (View on PubMed)

Other Identifiers

NIPH-2066

Identifier Type: -

Identifier Source: org_study_id