Comparison of Four Different Smoking Cessation Programmes - Full Text View

Purpose

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.

Condition	Intervention
Smoking Smoking Cessation Self-efficacy	Device: Standard 15-minute telephone counselling Device: Proactive telephone counselling Device: Interactive web-based smoking cessation programme Device: Self-help material

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Study of the Effect of Two Different Types of Telephone Counselling Respectively and a Web-based Smoking Cessation Programme Among Adult Daily Cigarette Smokers.

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking Smoking and Youth

U.S. FDA Resources

Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:

Smoking cessation [ Time Frame: 14 months post baseline ] [ Designated as safety issue: No ]
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:

Smoking cessation [ Time Frame: 3 month post baseline ] [ Designated as safety issue: No ]
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 [ Time Frame: 8 month post baseline ] [ Designated as safety issue: No ]
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 [ Time Frame: At 3, 8 and 14 months ] [ Designated as safety issue: No ]
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 [ Time Frame: At 3, 8 and 14 months ] [ Designated as safety issue: No ]
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 [ Time Frame: At 3, 8 and 14 months ] [ Designated as safety issue: No ]
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 [ Time Frame: at 3,8,14 months ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	1600
Study Start Date:	August 2011
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: ddsp.dk
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 Name: stoplinien.dk

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487642

Locations

Denmark
National institute of Public Health, University of Southern Denmark
Copenhagen, Denmark, 1353

Sponsors and Collaborators

University of Southern Denmark

Danish Cancer Society

National Board of Health, Denmark

Investigators

Principal Investigator:

Peter Dalum, Ph.d

University of Southern Denmark

More Information

No publications provided

Responsible Party:	Peter Dalum, Primary investigator, University of Southern Denmark
ClinicalTrials.gov Identifier:	NCT01487642 History of Changes
Other Study ID Numbers:	NIPH-2066
Study First Received:	November 24, 2011
Last Updated:	December 19, 2011
Health Authority:	Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:

Smoking
Habits

ClinicalTrials.gov processed this record on May 19, 2013

Comparison of Four Different Smoking Cessation Programmes (Fristart)