- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03849092
Smoking Cessation: Financial Incentives
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?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Frederiksberg, Denmark, 2000
- Center for Clinical Research and Prevention
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:smoker. -
Exclusion Criteria: non smoker, vaping of e-cigarettes (only)
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Financial incentive
3 municipalities will receive 120.000 DKK for financial incentives.
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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.
|
Experimental: Campaigns
3 municipalities will receive 120.000 DKK for campaigns.
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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.
|
No Intervention: Control
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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?
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12 months
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Smoking cessation rates
Time Frame: 6 months and 12 months
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Can we by offering financial incentives or by running a stop-smoking campaign achieve higher smoking cessation rates at municipal smoking cessation programs?
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6 months and 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment of smokers with low socioeconomic status
Time Frame: 6 weeks, 6 months and 12 months after quit date
|
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
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6 weeks, 6 months and 12 months after quit date
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Smoking cessation rates among citizens with low economic status
Time Frame: 6 weeks, 6 months and 12 months after quit date
|
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?
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6 weeks, 6 months and 12 months after quit date
|
Collaborators and Investigators
Investigators
- Principal Investigator: Charlotta Pisinger, Professor, MD, PhD, MPH, Centre for Clinical Research and Prevention
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 119404
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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