Clinical trial NCT01487642: Comparison of Four Different Smoking Cessation Programmes
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking
Smoking Cessation
Self-efficacy
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: National Board of Health, Denmark
First posted: 2011-12-07
Enrollment: 1600
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Smoking cessation
timeFrame: 14 months post baseline
Secondary outcomes:
measure: Smoking cessation
timeFrame: 3 month post baseline
measure: smoking cessation
timeFrame: 8 month post baseline
measure: Change in self-efficacy
timeFrame: At 3, 8 and 14 months
measure: Motivational change
timeFrame: At 3, 8 and 14 months
measure: Stage of change
timeFrame: At 3, 8 and 14 months
measure: Smoking cessation expectations
timeFrame: at 3,8,14 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: National institute of Public Health, University of Southern Denmark
Study officials:
affiliation: University of Southern Denmark
name: Peter Dalum, Ph.d
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.