Clinical trial NCT03849092: Smoking Cessation: Financial Incentives
Official title: Financial Incentive of Abstinence From Smoking as a Means of Recruiting Smokers With Low Socioeconomic Status to Smoking Cessation Programs in Municipalities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 1934
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

1. 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.
2. 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.
3. 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.

Eligibility criteria: Inclusion Criteria:smoker. -

Exclusion Criteria: non smoker, vaping of e-cigarettes (only)

-

Primary outcomes:
measure: Recruitment
timeFrame: 12 months
measure: Smoking cessation rates
timeFrame: 6 months and 12 months
Secondary outcomes:
measure: Recruitment of smokers with low socioeconomic status
timeFrame: 6 weeks, 6 months and 12 months after quit date
measure: Smoking cessation rates among citizens with low economic status
timeFrame: 6 weeks, 6 months and 12 months after quit date
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Center for Clinical Research and Prevention
Study officials:
affiliation: Centre for Clinical Research and Prevention
name: Charlotta Pisinger, Professor, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.