NCT05554120

Brief Summary

Few countries have legislation to reduce the number and types of tobacco retail outlets. The Netherlands plans to ban tobacco sales in supermarkets in 2024. 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 26, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

April 19, 2024

Status Verified

June 1, 2023

Enrollment Period

3.1 years

First QC Date

September 21, 2022

Last Update Submit

April 18, 2024

Conditions

Keywords

TobaccoPolicy evaluationSocial classSupermarkets

Outcome Measures

Primary Outcomes (3)

  • Impulse purchases of tobacco

    This is measured amongst smoking adults with the question "When you are shopping in a store in your neighborhood for something other than cigarettes, how often do you decide to buy cigarettes?" (1=Often, 2=Rarely, 3=Sometimes, 4=Often, 5=Always) (Siahpush et al., 2016).

    October 2022; October-November 2023, 2024, 2025

  • Smoking susceptibility

    This is measured amongst non-smoking adolescents with a three-item index, averaging responses to "Would you try smoking a cigarette if one of your best friends offered it to you?", "Do you think you would smoke in the next 6 months?", and "Are you curious about smoking?" (1=Definitely Not, 2=Probably Not, 3=Probably Yes, 4=Definitely Yes) (Strong et al., 2015).

    October 2022; October-November 2023, 2024, 2025

  • Number of smokers

    The investigators use data at the individual level. The investigators propose to use existing data from the lifestyle monitor of CBS (15,000 observations annually) and the polling station survey among students (8,000 observations every four years). For each individual the investigators link the area where they live.

    2018-2025

Secondary Outcomes (3)

  • Illegal (online) sales of tobacco

    October 2022; October-November 2023, 2024, 2025

  • Use and marketing of 'reduced risk' products

    October 2022; October-November 2023, 2024, 2025

  • Number and type of tobacco outlets

    2018-2025

Study Arms (3)

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.

Other: Supermarket tobacco sales ban

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).

Other: Supermarket tobacco sales ban

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).

Other: Supermarket tobacco sales ban

Interventions

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.

Non-smoking adolescentsSmoking adults from disadvantaged neighbourhoodsSmoking adults from non-disadvantaged neighbourhoods

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Respondents are recruited from NIPObase, a large probability-based access database that mirrors the Dutch population. NIPObase includes over 103,000 respondents in the general population who regularly participate in surveys from Kantar. With NIPObase the investigators are able to draw samples that are representative of the Dutch population according to known characteristics such as gender, age, geographic region, and household size.

You may qualify if:

  • Dutch-speaking
  • aged 12 to 17 years old at enrollment

You may not qualify if:

  • they have smoked (part of) a cigarette at least once a month during the last six months
  • not providing informed consent to participate
  • Smoking adults
  • Dutch-speaking
  • smoking at least monthly at enrollment
  • having smoked at least 100 cigarettes in their lifetime
  • not providing informed consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 26377520BACKGROUND
  • 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.

    PMID: 25481915BACKGROUND
  • 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.

MeSH Terms

Conditions

Tobacco SmokingSmokingSmoking CessationSmoking Reduction

Condition Hierarchy (Ancestors)

BehaviorTobacco UseHealth Behavior

Study Officials

  • Gera E Nagelhout, PhD

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2022

First Posted

September 26, 2022

Study Start

October 26, 2022

Primary Completion

December 1, 2025

Study Completion

May 1, 2026

Last Updated

April 19, 2024

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations