The Next Step in Smoking Prevention: the Reduction of Tobacco Retail Outlets, a Comprehensive Policy Evaluation
NCT ID: NCT05554120
Last Updated: 2024-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
1450 participants
OBSERVATIONAL
2022-10-26
2026-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
In a comprehensive policy evaluation, the investigators plan to examine (1) the impact of the policy on the number and types of tobacco outlets, (2) the impact on attitudes and behaviors of smoking adults and non-smoking youth, and (3) the influence of the tobacco industry on the policy process and the retail environment. In addition, the investigators plan to focus on differential effects in disadvantaged neighborhoods, where both smoking rates and tobacco outlet density are typically highest.
The investigators bring together a unique combination of economic, psychological, and journalistic research methods. The investigators examine the impact of the new legislation on the amount and type of tobacco outlets and on the number of smokers by using routinely collected monitoring data. The investigators examine the impact of the legislation on smoking susceptibility of non-smoking youth and on impulse tobacco purchases by smoking adults with yearly quantitative surveys (two surveys before the policy implementation and two after) and with qualitative interviews and discussion sessions. The investigators examine whether these impacts differ for disadvantaged versus non-disadvantaged neighborhoods. The investigators examine what strategies the tobacco industry uses to influence the new legislation, policy processes, and the tobacco retail environment by performing a journalistic investigation, using for example documents obtained by Freedom of Information Act requests, (possibly) leaked documents from insider meetings, and interviews with insiders.
Our research will provide a comprehensive evaluation of the effects of the implementation of the proposed legislative measures. Based on our results, the investigators will formulate recommendations for the Dutch Cancer Society, the Dutch government, and for other countries who consider reducing the number of tobacco outlets; highlight potential areas for further development and improvement within the legislative framework and provide recommendations on how to counter the lobby from the tobacco industry.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Switching From Cigarettes to Tobacco Heating System on Coronary Atherosclerosis Progression
NCT05660798
Nicotine Replacement Provided at a Tertiary Care Hospital
NCT01614054
Smoking Topography Study 2018
NCT03498053
Supporting Smoke-Free Policy Compliance in Public Housing
NCT05016505
Promotion and Mitigation Factors Leading to Illegal Tobacco Purchases
NCT06001840
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Research direction: The investigators will do a comprehensive policy evaluation of the new Dutch legislation on tobacco outlets. The investigators examine:
* The effects of the legislation on the number of tobacco sales outlets.
* The effects of the reduced number of sales outlets (if any) on the number of smokers.
* The effects on smoking susceptibility among non-smoking youth.
* The effects on impulse tobacco purchases of smoking adults.
* How these impacts differ for those living in disadvantaged versus non-disadvantaged neighborhoods.
* The strategies that the tobacco industry uses to influence the national legislation on tobacco outlets.
* And the strategies that the tobacco industry uses to influence the tobacco retail environment in the Netherlands.
Aim: The overall aim of this proposed research is to evaluate the implementation of new legislation to reduce the number and types of tobacco outlets in the Netherlands, up until and including the ban on sales of tobacco in supermarkets.
Primary research questions are:
What is the impact of the new legislation on the number and type of tobacco outlets? What is the impact of the new legislation by supermarkets on the number of smokers? What is the impact of the new legislation on smoking susceptibility of non-smoking youth? What is the impact of the new legislation on impulse tobacco purchases by smoking adults? Does this impact differ for smoking adults living in disadvantaged versus non-disadvantaged neighborhoods? What strategies does the tobacco industry use to influence the new legislation and policy processes? What strategies does the tobacco industry use to influence the tobacco retail environment?
Secondary research questions are:
How do non-smoking youth and smoking adults experience the new legislation? To what extent does the new legislation lead to more illegal (online) sales of tobacco and what is the role of the tobacco industry in this? What is the impact of the new legislation on use and marketing of 'reduced risk' products such as electronic cigarettes and heated tobacco?
Expected outcome: Our research will provide a comprehensive evaluation of the effects of the implementation of the proposed measures on the reduction of tobacco outlets. The four organizations that carry out this research have worked closely together in the past on comparable research projects and will ensure that the three parts of the project will come together to provide a comprehensive picture. Based on our results, the investigators will formulate recommendations for the Dutch Cancer Society, the Dutch government, and for other countries who consider reducing the number of tobacco outlets. The investigators will highlight potential areas for further development and improvement within the legislative framework and provide recommendations on how to counter the lobby from the tobacco industry.
Plan of Investigation:
The proposed research consists of three parts:
1. In the first part, the investigators examine the effects of the legislation on the number of tobacco sales outlets. The investigators also study the effects of the reduced number of sales outlets (if any) on the number of smokers. Both are examined separately for disadvantaged and non-disadvantaged neighborhoods. For this work package the investigators rely on existing data on retail locations and smoking prevalence. The investigators use data from 2018 to 2025 to account for existing trends. This part will be carried out by a research institute that specializes in economic analyses (SEO Amsterdam Economic) sand has done previous analyses with sales outlet and smoking prevalence data.
2. In the second part, the investigators examine the effects of the legislation on smoking susceptibility among nonsmoking youth and on impulse tobacco purchases of smoking adults. The investigators also examine how the effects differ for smoking adults living in disadvantaged versus non-disadvantaged neighborhoods. The investigators will conduct yearly, quantitative survey waves from 2022 to 2025 among a cohort of 250 non-smoking youth, 600 smoking adults from disadvantaged neighborhoods, and 600 smoking adults from non-disadvantaged neighborhoods. The investigators will also carry out in-depth qualitative interviews and discussion sessions with non-smoking youth and smoking adults from these three groups. This part will be carried out by a research institute that specializes in mixed-methods addiction research (IVO research Institute) and focuses on vulnerable groups in society, together with a university department of Health Promotion (Maastricht University) that has ample experience with tobacco control policy evaluations.
3. In the third part, the investigators examine the strategies of the tobacco industry to influence both the national legislation on tobacco outlets, and to influence the tobacco retail environment. The investigators use investigative journalism techniques to uncover lobbying strategies and tactics of the tobacco industry and their allies. The investigators use a wide range of sources: documents obtained by FOIA-requests, (possibly) leaked documents from insider meetings, (background) interviews with insiders of the tobacco industry, the government, and the retail sector, the analysis of social media campaigns, financial and marketing data, and observations of tobacco outlets (online and offline). This part will be carried out by an organization of investigative journalists that specializes in the strategies and tactics of the tobacco industry (The Investigative Desk).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Non-smoking adolescents
Non-smoking youth aged 12-17 years old. As the investigators monitor the cohort, it is possible that some of the cohort will become smokers.
Supermarket tobacco sales ban
In 2024, a ban on the sales of tobacco for supermarkets is planned by the Dutch government. Supermarkets accounted for approximately 40% of tobacco outlets in the Netherlands in 2021.
Smoking adults from disadvantaged neighbourhoods
Smoking adults aged 18 years and older from disadvantaged neighbourhoods. The investigators distinguish between disadvantaged and non-disadvantaged neighborhoods by using data from CBS Statistics Netherlands (CBS).
Supermarket tobacco sales ban
In 2024, a ban on the sales of tobacco for supermarkets is planned by the Dutch government. Supermarkets accounted for approximately 40% of tobacco outlets in the Netherlands in 2021.
Smoking adults from non-disadvantaged neighbourhoods
Smoking adults aged 18 years and older from non-disadvantaged neighbourhoods. The investigators distinguish between disadvantaged and non-disadvantaged neighborhoods by using data from CBS Statistics Netherlands (CBS).
Supermarket tobacco sales ban
In 2024, a ban on the sales of tobacco for supermarkets is planned by the Dutch government. Supermarkets accounted for approximately 40% of tobacco outlets in the Netherlands in 2021.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Supermarket tobacco sales ban
In 2024, a ban on the sales of tobacco for supermarkets is planned by the Dutch government. Supermarkets accounted for approximately 40% of tobacco outlets in the Netherlands in 2021.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* aged 12 to 17 years old at enrollment
* Dutch-speaking
* smoking at least monthly at enrollment
* having smoked at least 100 cigarettes in their lifetime
Exclusion Criteria
* not providing informed consent to participate
Smoking adults
* not providing informed consent to participate
12 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Investigative Desk
UNKNOWN
SEO Amsterdam Economics
UNKNOWN
IVO Research Institute
UNKNOWN
Maastricht University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gera E Nagelhout, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Maastricht University
Maastricht, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Siahpush M, Shaikh RA, Hyland A, Smith D, Sikora Kessler A, Meza J, Wan N, Wakefield M. Point-of-Sale Cigarette Marketing, Urge to Buy Cigarettes, and Impulse Purchases of Cigarettes: Results From a Population-Based Survey. Nicotine Tob Res. 2016 May;18(5):1357-62. doi: 10.1093/ntr/ntv181. Epub 2015 Sep 16.
Strong DR, Hartman SJ, Nodora J, Messer K, James L, White M, Portnoy DB, Choiniere CJ, Vullo GC, Pierce J. Predictive Validity of the Expanded Susceptibility to Smoke Index. Nicotine Tob Res. 2015 Jul;17(7):862-9. doi: 10.1093/ntr/ntu254. Epub 2014 Dec 6.
Nagelhout GE, Poole NL, Metze M, Willemsen MC, Vermeulen W, van den Brand FA. Reducing the number and types of tobacco retail outlets in the Netherlands: Study protocol for a comprehensive mixedmethods policy evaluation. Tob Prev Cessat. 2023 Mar 29;9:08. doi: 10.18332/tpc/161825. eCollection 2023.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KWF140282021-2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.