Comparison of Four Different Smoking Cessation Programmes (Fristart)

Study of the Effect of Two Different Types of Telephone Counselling Respectively and a Web-based Smoking Cessation Programme Among Adult Daily Cigarette Smokers.

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.

Study Overview

• Status: Unknown
• Conditions: Smoking; Smoking Cessation; Self-efficacy
• Intervention / Treatment: Device: Standard 15-minute telephone counselling; Device: Proactive telephone counselling; Device: Interactive web-based smoking cessation programme; Device: 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 Type: Interventional
• Enrollment (Anticipated): 1600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 1353
    • National Institute of Public Health, University of Southern Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Self-help material	Device: Self-help material; Participants receives self-help materials and on request information on other smoking cessation services if they wish.; Other Names: stoplinien.dk
Experimental: Telephone counselling	Device: 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.; Other Names: Stoplinien.dk; 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.; Other Names: Stoplinien.dk
Experimental: Proactive telephone counselling	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.; Other Names: Stoplinien.dk
Experimental: web-based smoking cessation programme	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.; Other Names: ddsp.dk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking cessation	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.	14 months post baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking cessation	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.	3 month post baseline
smoking cessation	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.	8 month post baseline
Change in self-efficacy	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.	At 3, 8 and 14 months
Motivational change	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.	At 3, 8 and 14 months
Stage of change	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").	At 3, 8 and 14 months
Smoking cessation expectations	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.	at 3,8,14 months

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Danish Cancer Society; National Board of Health, Denmark
• Investigators: Principal Investigator: Peter Dalum, Ph.d, University of Southern Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): November 1, 2012
• Study Completion (Anticipated): November 1, 2012

Study Registration Dates

• First Submitted: November 24, 2011
• First Submitted That Met QC Criteria: December 5, 2011
• First Posted (Estimate): December 7, 2011

Study Record Updates

• Last Update Posted (Estimate): December 20, 2011
• Last Update Submitted That Met QC Criteria: December 19, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: NIPH-2066