Smoking CessationNCT03849092
Smoking Cessation: Financial Incentives
A study testing Financial incentives and Campaigns in people with Smoking Cessation, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The aim of this intervention is to test if the investigator, by offering a financial incentive to smokers who abstinence from smoking, can: 1. recruit more smokers with low socioeconomic status to municipal smoking cessation programs 2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Financial incentives and Campaigns
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,934 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2018to 30 Jul 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Exclusion Criteria: non smoker, vaping of e-cigarettes (only)
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Financial Incentive of Abstinence From Smoking as a Means of Recruiting Smokers With Low Socioeconomic Status to Smoking Cessation Programs in Municipalities
The aim of this intervention is to test if the investigator, by offering a financial incentive to smokers who abstinence from smoking, can:
- recruit more smokers with low socioeconomic status to municipal smoking cessation programs
- achieve higher abstinence rates at municipal smoking cessation programs among citizens with low economic status - Rather than by use of campaigns (=usual strategy) informing citizens about their options for support at municipal smoking cessation programs?
Read the detailed description
For decades the prevalence of smokers has been declining. However, during the last four years the prevalence is stagnated. All municipalities are offering support to/ and during smoking cessation. Nevertheless, a lot of the municipalities find it very difficult to recruit smokers to their programs - in particular smokers with low socioeconomic status.
Hypothesis: It is assumed that more smokers with low socioeconomic status, which are otherwise very difficult to reach with smoking cessation offerings, will attend in municipal smoking cessation programs if they are offered a financial incentive. It is also assumed that smokers with low socioeconomic status, who have difficulty quitting smoking, will achieve higher smoking cessation rates if they are offered a financial incentive of abstinence from smoking. The target group of this study is therefore smokers with low socioeconomic status (SES).
The study involves 6 intervention municipalities (3 financial incentives municipalities and 3 campaign municipalities), and 6 control municipalities. The investigator conducts matched randomization at municipality level, and matches the municipalities on number of smokers recruited to smoking cessation programs in the previous year (2017).
All 6 intervention municipalities receive 102.000 DKK (16536,43 UDS) which must be used on their intervention. Beside the intervention everything goes on as usual in each municipality. Each municipality is its own control and the change will be analyzed after the intervention. The prevalence of smokers in each municipality is registered as usual by means of the Health Profiles, however not in this study!, which aim not is to measure the number of citizens quitting smoking unaided, but solely aim to focus on the municipals smoking cessation activities.
- Intervention in the 3 financial incentives municipalities: the municipalities will make simple invitations and advertisements, showing that smokers can achieve a financial incentive of 1200 DKK if they abstinence from smoking. The period of a smoking cessation program is 7 weeks, and participants will receive a financial incentive as a gift voucher the 4 last meeting days, if validated abstinent from smoking.
- Intervention in the 3 campaign municipalities: each municipality decides how the campaigns/advertisement should look/be like. The campaign should try to target smokers with low SES, recommending getting support during smoking cessation.
- Control municipalities: 6 "clean" control municipalities perform their smoking cessation activities as usual and do not receive any financial resources. They do not know that they are control group in a trial.
The investigators measure validated recruitment- and abstinence rates 6 and 12 months after last session.
- Conditions
- Smoking Cessation
- Being tested
- Financial incentives, Campaigns
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial incentivesBehavioural
Cessation programs in municipalities will offer a financial incentive of 1200 DKK to smokers who achieve continuous abstinence from smoking when attending a group-based smoking cessation program. Aimed at smokers with low socioeconomic status but other smokers are also included.
CampaignsBehavioural
Municipalities will design anti-smoking campaigns targeting smokers, recommending to use a municipal free group-based smoking cessation program. Aimed at smokers with low socioeconomic status but other smokers are also included.
| Study group | Role | What they receive |
|---|---|---|
| Financial incentive | Experimental | 3 municipalities will receive 120.000 DKK for financial incentives. Receives: Behavioral: Financial incentives |
| Campaigns | Experimental | 3 municipalities will receive 120.000 DKK for campaigns. Receives: Behavioral: Campaigns |
| Control | No intervention | 6 "clean" control municipalities perform their smoking cessation activities as usual. They wont receive any financial resources. These muncipalities have not been randomly selected but have been matched (by number of smokers attending the smoking cessation groups in the municipality in 2017, the year before the intervention). 3 of them are Campaing Control group and 3 are Finacial Incentives Control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Can we by offering financial incentives or by running a stop-smoking campaign recruit more smokers to municipal smoking cessation programs?
Measured: 12 months
Smoking cessation rates
Can we by offering financial incentives or by running a stop-smoking campaign achieve higher smoking cessation rates at municipal smoking cessation programs?
Measured: 6 months and 12 months
Secondary outcomes (2)
Recruitment of smokers with low socioeconomic status
Can we by offering financial incentives or by running a stop-smoking campaign recruit more smokers with low socioeconomic status to municipal smoking cessation programs
Measured: 6 weeks, 6 months and 12 months after quit date
Smoking cessation rates among citizens with low economic status
Can we by offering financial incentives or by running a stop-smoking camaign achieve higher smoking cessation rates at municipal smoking cessation programs among citizens with low economic status?
Measured: 6 weeks, 6 months and 12 months after quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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
- 1,934 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotta Pisinger, Glostrup University Hospital, Copenhagen
- Investigators
- Charlotta Pisinger, Professor, MD, PhD, MPH, Principal investigator, Centre for Clinical Research and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849092
- Sponsor's protocol ID
- 119404
- Status last verified
- Aug 2020
- First submitted
- 22 Feb 2018
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pisinger C, Toxvaerd CG, Rasmussen M. Are financial incentives more effective than health campaigns to quit smoking? A community-randomised smoking cessation trial in Denmark. Prev Med. 2022 Jan;154:106865. doi: 10.1016/j.ypmed.2021.106865. Epub 2021 Nov 3.
PubMed 34740676
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Incentive of Abstinence From Smoking as a Means of Recruiting Smokers With Low Socioeconomic Status to Smoking Cessation Programs in Municipalities
- ClinicalTrials.gov ID
- NCT03849092
- Acronym / sponsor ID
- 119404
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,934 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 21 Feb 2019 (actual)
- 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 aim of this intervention is to test if the investigator, by offering a financial incentive to smokers who abstinence from smoking, can:
- recruit more smokers with low socioeconomic status to municipal smoking cessation programs
- achieve higher abstinence rates at municipal smoking cessation programs among citizens with low economic status - Rather than by use of campaigns (=usual strategy) informing citizens about their options for support at municipal smoking cessation programs?
Detailed description
For decades the prevalence of smokers has been declining. However, during the last four years the prevalence is stagnated. All municipalities are offering support to/ and during smoking cessation. Nevertheless, a lot of the municipalities find it very difficult to recruit smokers to their programs - in particular smokers with low socioeconomic status.
Hypothesis: It is assumed that more smokers with low socioeconomic status, which are otherwise very difficult to reach with smoking cessation offerings, will attend in municipal smoking cessation programs if they are offered a financial incentive. It is also assumed that smokers with low socioeconomic status, who have difficulty quitting smoking, will achieve higher smoking cessation rates if they are offered a financial incentive of abstinence from smoking. The target group of this study is therefore smokers with low socioeconomic status (SES).
The study involves 6 intervention municipalities (3 financial incentives municipalities and 3 campaign municipalities), and 6 control municipalities. The investigator conducts matched randomization at municipality level, and matches the municipalities on number of smokers recruited to smoking cessation programs in the previous year (2017).
All 6 intervention municipalities receive 102.000 DKK (16536,43 UDS) which must be used on their intervention. Beside the intervention everything goes on as usual in each municipality. Each municipality is its own control and the change will be analyzed after the intervention. The prevalence of smokers in each municipality is registered as usual by means of the Health Profiles, however not in this study!, which aim not is to measure the number of citizens quitting smoking unaided, but solely aim to focus on the municipals smoking cessation activities.
- Intervention in the 3 financial incentives municipalities: the municipalities will make simple invitations and advertisements, showing that smokers can achieve a financial incentive of 1200 DKK if they abstinence from smoking. The period of a smoking cessation program is 7 weeks, and participants will receive a financial incentive as a gift voucher the 4 last meeting days, if validated abstinent from smoking.
- Intervention in the 3 campaign municipalities: each municipality decides how the campaigns/advertisement should look/be like. The campaign should try to target smokers with low SES, recommending getting support during smoking cessation.
- Control municipalities: 6 "clean" control municipalities perform their smoking cessation activities as usual and do not receive any financial resources. They do not know that they are control group in a trial.
The investigators measure validated recruitment- and abstinence rates 6 and 12 months after last session.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Financial incentive | Experimental | Behavioral: Financial incentives3 municipalities will receive 120.000 DKK for financial incentives. |
| Campaigns | Experimental | Behavioral: Campaigns3 municipalities will receive 120.000 DKK for campaigns. |
| Control | No intervention | –6 "clean" control municipalities perform their smoking cessation activities as usual. They wont receive any financial resources. These muncipalities have not been randomly selected but have been matched (by number of smokers attending the smoking cessation groups in the municipality in 2017, the year before the intervention). 3 of them are Campaing Control group and 3 are Finacial Incentives Control group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Exclusion Criteria: non smoker, vaping of e-cigarettes (only)
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Financial incentivesCessation programs in municipalities will offer a financial incentive of 1200 DKK to smokers who achieve continuous abstinence from smoking when attending a group-based smoking cessation program. Aimed at smokers with low socioeconomic status but other smokers are also included. | Behavioural | Financial incentive |
| CampaignsMunicipalities will design anti-smoking campaigns targeting smokers, recommending to use a municipal free group-based smoking cessation program. Aimed at smokers with low socioeconomic status but other smokers are also included. | Behavioural | Campaigns |
Primary outcome
Recruitment
Time frame: 12 months
Can we by offering financial incentives or by running a stop-smoking campaign recruit more smokers to municipal smoking cessation programs?
Smoking cessation rates
Time frame: 6 months and 12 months
Can we by offering financial incentives or by running a stop-smoking campaign achieve higher smoking cessation rates at municipal smoking cessation programs?
2 secondary outcomes
Recruitment of smokers with low socioeconomic status
Time frame: 6 weeks, 6 months and 12 months after quit date
Smoking cessation rates among citizens with low economic status
Time frame: 6 weeks, 6 months and 12 months after quit date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Derived from this study: PubMed 34740676Pisinger C, Toxvaerd CG, Rasmussen M. Are financial incentives more effective than health campaigns to quit smoking? A community-randomised smoking cessation trial in Denmark. Prev Med. 2022 Jan;154:106865. doi: 10.1016/j.ypmed.2021.106865. Epub 2021 Nov 3.
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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.
Charlotta Pisinger, Professor, MD, PhD, MPH principal investigator
Centre for Clinical Research and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial incentives and Campaigns in people with Smoking Cessation, run by Glostrup University Hospital, Copenhagen 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 2 inclusion and 0 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: finished, as of the sponsor's last update on 26 Aug 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recruitment (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT03849092, which also lists 1 linked publication.
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 26 Aug 2020.