Comparison of Four Different Smoking Cessation Programmes

Not Applicable

• Conditions: Smoking; Smoking Cessation; Self-efficacy
• Interventions: Device: Standard 15-minute telephone counselling; Device: Interactive web-based smoking cessation programme; Device: Self-help material; Device: Proactive telephone counselling

• Registration Number: NCT01487642
• Lead Sponsor: University of Southern Denmark

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-11-24
• Status Verified: 2011-12
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-07
• Last Update Submitted: 2011-12-19
• Last Update Posted: 2011-12-20
• Primary Completion: 2012-11
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telephone counselling	Standard 15-minute telephone counselling	-
Telephone counselling	Proactive telephone counselling	-
Proactive telephone counselling	Proactive telephone counselling	-
web-based smoking cessation programme	Interactive web-based smoking cessation programme	-
Self-help material	Self-help material	-

Primary Outcome Measures

Name	Time	Method
Smoking cessation	14 months post baseline	We measure the 30 days point prevalence abstinence rate. We measure whether participants have been totally smokefree for at least 30 days prior to the follow-up date.

Secondary Outcome Measures

Name	Time	Method
smoking cessation	8 month post baseline	We measure the 30 days point prevalence abstinence rate. We measure whether participants have been totally smokefree for at least 30 days prior to the follow-up date.
Smoking cessation	3 month post baseline	We measure the 30 days point prevalence abstinence rate. We measure whether participants have been totally smokefree for at least 30 days prior to the follow-up date.
Change in self-efficacy	At 3, 8 and 14 months	Self-efficacy (SE) is measured on a 12 item scale. SE describes the individuals belief in own capacity to refrain from smoking in 12 specific situations. SE change is defined af the difference between baseline SE and SE at the 3,8 and 14 months follow-ups.
Motivational change	At 3, 8 and 14 months	Motivation was measured on a 10 point scale. ("How important is it for you to quit smoking"). Motivational change is defined af the difference between baseline motivation and motivation at the 3,8 and 14 months follow-ups.
Stage of change	At 3, 8 and 14 months	A measure of the participants intentions to quit smoking in the future ("Do you have plans to quit smoking? yes, within the next 30 days; yes, within the next six months; yes, but I no specific plans; No").
Smoking cessation expectations	at 3,8,14 months	We look at differences from baseline to follow-up with regard to participants perception of being smokefree on a six item scale: activities, physical fitness, health, appearance, happiness, stress.

Trial Locations

Locations (1)

National institute of Public Health, University of Southern Denmark; 🇩🇰 Copenhagen, Denmark