SmokingFristartNCT01487642
Comparison of Four Different Smoking Cessation Programmes
A study testing Standard 15-minute telephone counselling, Proactive telephone counselling and Interactive web-based smoking cessation programme in people with Smoking and Smoking Cessation, run by University of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Cessation, Self-efficacy
- What is being tested?
- Standard 15-minute telephone counselling, Proactive telephone counselling and Interactive web-based smoking cessation programme
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Less than 16 years of age
- No personal e-mail address
- No personal mobile cell phone
- Not able to give informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
National institute of Public Health, University of Southern Denmark
Copenhagen, 1353
About this study
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.
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.
Read the 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.
- Conditions
- Smoking, Smoking Cessation, Self-efficacy
- Being tested
- Standard 15-minute telephone counselling, Proactive telephone counselling, Interactive web-based smoking cessation programme, Self-help material
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard 15-minute telephone counsellingDevice
Also called Stoplinien.dk
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.
Proactive telephone counsellingDevice
Also called Stoplinien.dk
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.
Interactive web-based smoking cessation programmeDevice
Also called ddsp.dk
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.
Self-help materialDevice
Also called stoplinien.dk
Participants receives self-help materials and on request information on other smoking cessation services if they wish.
| Study group | Role | What they receive |
|---|---|---|
| Telephone counselling | Experimental | Not described Receives: Device: Standard 15-minute telephone counselling; Device: Proactive telephone counselling |
| Proactive telephone counselling | Experimental | Not described Receives: Device: Proactive telephone counselling |
| web-based smoking cessation programme | Experimental | Not described Receives: Device: Interactive web-based smoking cessation programme |
| Self-help material | Active comparator | Not described Receives: Device: Self-help material |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 months post baseline
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 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.
Measured: at 3,8,14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society, National Board of Health, Denmark
- Responsible party
- Principal investigator, Peter Dalum, University of Southern Denmark
- Investigators
- Peter Dalum, Ph.d, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487642
- Sponsor's protocol ID
- NIPH-2066
- Acronym
- Fristart
- Status last verified
- Dec 2011
- First submitted
- 24 Nov 2011
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
PubMed 39868569Skov-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.
PubMed 26748541
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01487642
- Acronym / sponsor ID
- Fristart / NIPH-2066
- Conditions
- Smoking, Smoking Cessation, Self-efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Danish Cancer Society, National Board of Health, Denmark
- Study start
- Aug 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 7 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Telephone counselling | Experimental | Device: Standard 15-minute telephone counselling, Device: Proactive telephone counselling |
| Proactive telephone counselling | Experimental | Device: Proactive telephone counselling |
| web-based smoking cessation programme | Experimental | Device: Interactive web-based smoking cessation programme |
| Self-help material | Active comparator | Device: Self-help material |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Less than 16 years of age
- No personal e-mail address
- No personal mobile cell phone
- Not able to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard 15-minute telephone counsellingAlso: Stoplinien.dkSubjects 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. | Device | Telephone counselling |
| Proactive telephone counsellingAlso: Stoplinien.dksubjects 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. | Device | Proactive telephone counselling, Telephone counselling |
| Interactive web-based smoking cessation programmeAlso: ddsp.dkSubjects 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. | Device | web-based smoking cessation programme |
| Self-help materialAlso: stoplinien.dkParticipants receives self-help materials and on request information on other smoking cessation services if they wish. | Device | Self-help material |
Primary outcome
Smoking cessation
Time frame: 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.
6 secondary outcomes
Smoking cessation
Time frame: 3 month post baseline
smoking cessation
Time frame: 8 month post baseline
Change in self-efficacy
Time frame: At 3, 8 and 14 months
Motivational change
Time frame: At 3, 8 and 14 months
Stage of change
Time frame: At 3, 8 and 14 months
Smoking cessation expectations
Time frame: at 3,8,14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2011.
- Derived from this study: PubMed 39868569Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
- Derived from this study: PubMed 26748541Skov-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Dalum, Ph.d principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard 15-minute telephone counselling, Proactive telephone counselling and Interactive web-based smoking cessation programme in people with Smoking and Smoking Cessation, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking cessation (time frame: 14 months post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01487642, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2011.