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Comparison of Four Different Smoking Cessation Programmes

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01487642
Acronym
Fristart
Enrollment
1600
Registered
2011-12-07
Start date
2011-08-31
Completion date
2012-11-30
Last updated
2011-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Self-efficacy, Smoking, Smoking Cessation

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.

Interventions

DEVICEStandard 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.

DEVICEProactive 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.

DEVICEInteractive 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.

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

Sponsors

Danish Cancer Society
CollaboratorOTHER
National Board of Health, Denmark
CollaboratorOTHER_GOV
University of Southern Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Smoking cessation14 months post baselineWe 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

MeasureTime frameDescription
Smoking cessation3 month post baselineWe 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 cessation8 month post baselineWe 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 expectationsat 3,8,14 monthsWe 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.
Motivational changeAt 3, 8 and 14 monthsMotivation 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 changeAt 3, 8 and 14 monthsA 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).
Change in self-efficacyAt 3, 8 and 14 monthsSelf-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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026