Tobacco UseNCT04632030
Shrinking the Size of the Tobacco Power Wall
A study testing Tobacco power wall size and tobacco products displayed in people with Tobacco Use, run by RAND at 1 site in United States.
Trial summary
The overall aim of this research is to experimentally evaluate the extent to which reducing the size of the tobacco power wall and the number of tobacco product units displayed influences tobacco use risk in adolescents. Read more about this study
- Who is it for?
- Ages 11 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- Tobacco power wall size and tobacco products displayed
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2020to 29 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 11 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- between the ages of 11 and 20
Who cannot join
- any medical or psychological condition that would make participation in the procedures of the study difficult (based on self-report).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shrinking the Size of the Tobacco Power Wall and Restricting the Number of Tobacco Products Displayed to Reduce Adolescent Tobacco Use
The overall aim of this research is to experimentally evaluate the extent to which reducing the size of the tobacco power wall and the number of tobacco product units displayed influences tobacco use risk in adolescents.
Read the detailed description
This experiment will take place in the RAND StoreLab (RSL), a life-sized replica of a convenience store that we developed to evaluate how altering aspects of tobacco promotion at POS influences tobacco use risk during simulated shopping experiences. The study will use a between-subjects design, in which adolescents are randomly assigned to shop in the RSL under one of three conditions: (1) Large power wall/ multiple product units displayed; (2) Medium-sized power wall/multiple product units displayed; and (3) Small power wall/single product units displayed. We will consider the effect of these power wall alterations on risk of use of four classes of tobacco products: cigarettes, electronic nicotine delivery devices, cigarillos, and smokeless tobacco.
- Conditions
- Tobacco Use
- Being tested
- Tobacco power wall size and tobacco products displayed
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco power wall size and tobacco products displayedBehavioural
The intervention varies the size of the tobacco power wall and number of tobacco products displayed on it.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The tobacco power wall and number of products appears in a typical format: large power wall with a large number of products (defined here as three large cabinets) Receives: Behavioral: Tobacco power wall size and tobacco products displayed |
| Small | Experimental | The tobacco power wall and number of tobacco products appear in their smallest format: small power wall with a small number of products displayed (defined here as one large cabinet) Receives: Behavioral: Tobacco power wall size and tobacco products displayed |
| Medium | Experimental | The tobacco power wall and number of tobacco products appear in a format sized between the control and small conditions: a medium sized power wall with a medium number of products displayed (defined here as two large cabinets). Receives: Behavioral: Tobacco power wall size and tobacco products displayed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion at Risk for Cigarette Smoking
A two item self-report assessment: 1) If one of your best friends offered you an unflavored cigarette would you use it? 2) If one of your best friends offered you a menthol cigarette would you use it? Responses to each item are made on a 10-point scale where 1 = definitely not; and 10 = definitely yes and responses across the two items are summed for a total scale score. Total scale scores are dichotomized: scores of 2 are coded as '0' (no risk) and any score greater than 2 is coded as '1' (at risk). Outcome is proportion at risk of cigarette smoking (number of participants at risk over number of participants within condition).
Measured: within 5 minutes of the intervention
Proportion at Risk of Using Electronic Nicotine Delivery Devices (ENDS)
A three item, self-report assessment: 1) If one of your best friends offered you an unflavored vaping product would you use it? 2) If one of your best friends offered you a vaping product flavored with menthol or mint, would you use it? 3) If one of your best friends offered you a vaping product flavored with fruit, candy, alcohol or non-alcohol drink, or some other sweet flavor, would you use it? Responses to each item are made on a 10-point scale where 1 = definitely not; and 10 = definitely yes and responses across the three items are summed for a total scale score. Total scale scores are dichotomized: scores of 3 are coded as '0' (no risk) and any score greater than 3 is coded as '1' (at risk). Outcome is proportion at risk of ENDS use (number of participants at risk over number of participants within condition).
Measured: within 5 minutes of the intervention
Proportion at Risk of Using Smokeless Tobacco
A three item self report assessment: : 1) If one of your best friends offered you unflavored smokeless tobacco would you use it? 2) If one of your best friends offered you smokeless tobacco flavored with flavored with menthol, mint, spearmint, or wintergreen would you use it? 3) If one of your best friends offered you smokeless tobacco flavored with fruit would you use it? Responses to each item are made on a 10-point scale where 1 = definitely not; and 10 = definitely yes and responses across the three items are summed for a total scale score. Total scale scores are dichotomized: scores of 3 are coded as '0' (no risk) and any score greater than 3 is coded as '1' (at risk).Outcome is proportion at risk of smokeless tobacco use (number of participants at risk over number of participants within condition).
Measured: within 5 minutes of the intervention
Proportion at Risk of Using Little Cigar/Cigarillos (LCC)
A three item, self report assessment: 1) If one of your best friends offered you an unflavored cigarillos/filtered cigar would you use it? 2) If one of your best friends offered you a cigarillos/filtered cigar flavored with menthol or mint would you use it? 3) If one of your best friends offered you a cigarillos/filtered cigar flavored with fruit, candy, alcohol, or some other sweet flavor, would you use it? Responses to each item are made on a 10-point scale where 1 = definitely not; and 10 = definitely yes and responses across the three items are summed for a total scale score. Total scale scores are dichotomized: scores of 3 are coded as '0' (no risk) and any score greater than 3 is coded as '1' (at risk). Outcome is proportion at risk of LCC use (number of participants at risk over number of participants within condition).
Measured: within 5 minutes of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start30 Oct 2020
- Primary completion29 Aug 2022
- Study completion29 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco UseStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Shadel, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632030
- Sponsor's protocol ID
- R01DA050972
- Status last verified
- Oct 2023
- First submitted
- 10 Nov 2020
- Last updated
- 25 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shrinking the Size of the Tobacco Power Wall and Restricting the Number of Tobacco Products Displayed to Reduce Adolescent Tobacco Use
- ClinicalTrials.gov ID
- NCT04632030
- Acronym / sponsor ID
- R01DA050972
- Conditions
- Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 29 Aug 2022 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Posted 25 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of this research is to experimentally evaluate the extent to which reducing the size of the tobacco power wall and the number of tobacco product units displayed influences tobacco use risk in adolescents.
Detailed description
This experiment will take place in the RAND StoreLab (RSL), a life-sized replica of a convenience store that we developed to evaluate how altering aspects of tobacco promotion at POS influences tobacco use risk during simulated shopping experiences. The study will use a between-subjects design, in which adolescents are randomly assigned to shop in the RSL under one of three conditions: (1) Large power wall/ multiple product units displayed; (2) Medium-sized power wall/multiple product units displayed; and (3) Small power wall/single product units displayed. We will consider the effect of these power wall alterations on risk of use of four classes of tobacco products: cigarettes, electronic nicotine delivery devices, cigarillos, and smokeless tobacco.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Tobacco power wall size and tobacco products displayedThe tobacco power wall and number of products appears in a typical format: large power wall with a large number of products (defined here as three large cabinets) |
| Small | Experimental | Behavioral: Tobacco power wall size and tobacco products displayedThe tobacco power wall and number of tobacco products appear in their smallest format: small power wall with a small number of products displayed (defined here as one large cabinet) |
| Medium | Experimental | Behavioral: Tobacco power wall size and tobacco products displayedThe tobacco power wall and number of tobacco products appear in a format sized between the control and small conditions: a medium sized power wall with a medium number of products displayed (defined here as two large cabinets). |
Who may qualify
- Ages
- 11 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- between the ages of 11 and 20
Key exclusion criteria (1 listed)
- any medical or psychological condition that would make participation in the procedures of the study difficult (based on self-report).
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 |
|---|---|---|
| Tobacco power wall size and tobacco products displayedThe intervention varies the size of the tobacco power wall and number of tobacco products displayed on it. | Behavioural | Control, Medium, Small |
Primary outcome
Proportion at Risk for Cigarette Smoking
Time frame: within 5 minutes of the intervention
A two item self-report assessment: 1) If one of your best friends offered you an unflavored cigarette would you use it? 2) If one of your best friends offered you a menthol cigarette would you use it? Responses to each item are made on a 10-point scale where 1 = definitely not; and 10 = definitely yes and responses across the two items are summed for a total scale score. Total scale scores are dichotomized: scores of 2 are coded as '0' (no risk) and any score greater than 2 is coded as '1' (at risk). Outcome is proportion at risk of cigarette smoking (number of participants at risk over number of participants within condition).
Proportion at Risk of Using Electronic Nicotine Delivery Devices (ENDS)
Time frame: within 5 minutes of the intervention
A three item, self-report assessment: 1) If one of your best friends offered you an unflavored vaping product would you use it? 2) If one of your best friends offered you a vaping product flavored with menthol or mint, would you use it? 3) If one of your best friends offered you a vaping product flavored with fruit, candy, alcohol or non-alcohol drink, or some other sweet flavor, would you use it? Responses to each item are made on a 10-point scale where 1 = definitely not; and 10 = definitely yes and responses across the three items are summed for a total scale score. Total scale scores are dichotomized: scores of 3 are coded as '0' (no risk) and any score greater than 3 is coded as '1' (at risk). Outcome is proportion at risk of ENDS use (number of participants at risk over number of participants within condition).
Proportion at Risk of Using Smokeless Tobacco
Time frame: within 5 minutes of the intervention
A three item self report assessment: : 1) If one of your best friends offered you unflavored smokeless tobacco would you use it? 2) If one of your best friends offered you smokeless tobacco flavored with flavored with menthol, mint, spearmint, or wintergreen would you use it? 3) If one of your best friends offered you smokeless tobacco flavored with fruit would you use it? Responses to each item are made on a 10-point scale where 1 = definitely not; and 10 = definitely yes and responses across the three items are summed for a total scale score. Total scale scores are dichotomized: scores of 3 are coded as '0' (no risk) and any score greater than 3 is coded as '1' (at risk).Outcome is proportion at risk of smokeless tobacco use (number of participants at risk over number of participants within condition).
Proportion at Risk of Using Little Cigar/Cigarillos (LCC)
Time frame: within 5 minutes of the intervention
A three item, self report assessment: 1) If one of your best friends offered you an unflavored cigarillos/filtered cigar would you use it? 2) If one of your best friends offered you a cigarillos/filtered cigar flavored with menthol or mint would you use it? 3) If one of your best friends offered you a cigarillos/filtered cigar flavored with fruit, candy, alcohol, or some other sweet flavor, would you use it? Responses to each item are made on a 10-point scale where 1 = definitely not; and 10 = definitely yes and responses across the three items are summed for a total scale score. Total scale scores are dichotomized: scores of 3 are coded as '0' (no risk) and any score greater than 3 is coded as '1' (at risk). Outcome is proportion at risk of LCC use (number of participants at risk over number of participants within condition).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tobacco power wall size and tobacco products displayed in people with Tobacco Use, run by RAND at 1 site in United States.
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 1 inclusion and 1 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 25 Oct 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 25 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion at Risk for Cigarette Smoking (time frame: within 5 minutes of the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2023.