E-cigaretteNCT07129265
Understanding Vape Marketing Study
An observational study of E-cigarette and Vaping, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to develop an electronic cigarette (e-cigarette) counter-marketing lesson for adolescents. The lesson will involve short videos designed to improve adolescents' cognition of e-cigarette marketing in the retail environment with the overall goal of reducing their susceptibility to use… Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- E-cigarette, Vaping, Tobacco
- What is being tested?
- Working group and Focus group
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2025to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will include individuals residing in the U.S. There will be 10 members of the expert working group (2 middle, 2 high school students, 2 young adults, 1 educator, 1 parent, and 4 curriculum design experts). There will be 36 adolescent and young adult participants of the focus groups.
Who may be able to join
- Youth participants:
- Middle school students may be 13-15 years
- High schoolers may be 16-18 years
- Young adults may be 19-29 years
- Provide a phone number for at least one backup contact (e.g, parent/guardian)
- Curriculum design experts:
Show all 17Show fewer
- Experience of at least 1 year in tobacco prevention or relevant public health field
- Parent:
- Parent of a child who has e-cigarette use history or is currently using (preferred, but not essential)
- Educator:
- Currently employed as teacher at a middle/high school All participants
- Provide their cell phone number and email address
- Fluent in English
- Adolescents and young adults ages 13-21 years
- Fluent in English
- Provide their cell phone number and email address
- Provide a phone number for at least one backup contact
Who cannot join
- Express inability to participate consistently across study working group meetings.
- FOCUS GROUP PARTICIPANTS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Countering E-cigarette Marketing in the Retail Environment Among Adolescents and Young Adults
The purpose of this study is to develop an electronic cigarette (e-cigarette) counter-marketing lesson for adolescents. The lesson will involve short videos designed to improve adolescents' cognition of e-cigarette marketing in the retail environment with the overall goal of reducing their susceptibility to use, intent to use, and actual use of e-cigarettes. Through this study, the study team will identify and refine the key messages that would make this lesson acceptable, feasible to implement, and effective in altering e-cigarette-related perceptions and potentially behaviors.
Read the detailed description
This research comprises of 2 qualitative activities:
- Working group: The study team will purposively invite a convenience sample of expert members (including middle/high school students, young adults, an educator, a parent, and curriculum design experts) to convene multiple times over several weeks (3 meetings via videoconference). The working group will convene to view preliminary results from formative research, collaborate on the development of this lesson curriculum, and otherwise offer meaningful input on study materials.
- Focus groups: A convenience sample of adolescents/young adults will be enrolled to participate in a focus group via videoconferenc . Each participant will only participate in a single focus group. There will be ~4 participants in each focus group, and 9 focus groups overall. Before their focus group, each participant will complete a brief online survey that collects sociodemographics and outcome measures data. During their focus group, each participant will be asked to view and describe their opinion about broad counter-marketing strategies, messages, and participate in viewing mood-boards and video-storyboards using these messages. A trained facilitator will follow a standardized discussion guide to lead the focus groups.
These activities will occur sequentially over about 6 months. At the 6-month time point, the study team will have met the study's primary aim of having developed the e-cigarette counter-marketing lesson.
- Conditions
- E-cigarette, Vaping, Tobacco, Nicotine, Adolescent Behavior, Video Information
- Being tested
- Working group, Focus group
- Keywords
- e-cigarette, vaping, tobacco, nicotine, adolescent, counter-marketing, digital content, digital education interventions
- Medical subject headings
- Vaping, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Working groupOther
Participants will: 1) take a 10-min demographic survey; 2) join 3 x 60-min working group meetings in which they will review preliminary results, collaborate on curriculum design, and provide feedback; and 3) respond to prompts in 3 emails (approx 5-10 mins each).
Focus groupOther
Participants will take a 10-min demographic survey and join 1 x 30-min focus group meeting in which they will provide feedback on the curriculum in development.
| Study group | Role | What they receive |
|---|---|---|
| Working group members | 10 members of the expert working group: 2 middle school students, 2 high school students, 2 young adults, 1 educator, 1 parent, and 4 curriculum design expert Receives: Other: Working group | |
| Focus group participants | 36 adolescent/young adult participants Receives: Other: Focus group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of an e-cigarette counter-marketing lesson focused on the retail environment
Key messages and message-delivery strategy will be developed, potentially comprising of short-form videos. The study team will ask working group members to rank draft messages and strategies for delivery in addition to eliciting qualitative information.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start4 Aug 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E-cigaretteStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Dana-Farber/Harvard Cancer Center (DF/HCC) Boston, MA
- Responsible party
- Principal investigator, Shivani Gaiha, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129265
- Sponsor's protocol ID
- 25-232
- Other IDs
- 5R00CA267477
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant survey data will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Countering E-cigarette Marketing in the Retail Environment Among Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT07129265
- Acronym / sponsor ID
- 25-232
- Conditions
- E-cigarette, Vaping, Tobacco, Nicotine, Adolescent Behavior, Video Information
- Keywords
- e-cigarette, vaping, tobacco, nicotine, adolescent, counter-marketing, digital content, digital education interventions
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Dana-Farber/Harvard Cancer Center (DF/HCC) Boston, MA
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop an electronic cigarette (e-cigarette) counter-marketing lesson for adolescents. The lesson will involve short videos designed to improve adolescents' cognition of e-cigarette marketing in the retail environment with the overall goal of reducing their susceptibility to use, intent to use, and actual use of e-cigarettes. Through this study, the study team will identify and refine the key messages that would make this lesson acceptable, feasible to implement, and effective in altering e-cigarette-related perceptions and potentially behaviors.
Detailed description
This research comprises of 2 qualitative activities:
- Working group: The study team will purposively invite a convenience sample of expert members (including middle/high school students, young adults, an educator, a parent, and curriculum design experts) to convene multiple times over several weeks (3 meetings via videoconference). The working group will convene to view preliminary results from formative research, collaborate on the development of this lesson curriculum, and otherwise offer meaningful input on study materials.
- Focus groups: A convenience sample of adolescents/young adults will be enrolled to participate in a focus group via videoconferenc . Each participant will only participate in a single focus group. There will be ~4 participants in each focus group, and 9 focus groups overall. Before their focus group, each participant will complete a brief online survey that collects sociodemographics and outcome measures data. During their focus group, each participant will be asked to view and describe their opinion about broad counter-marketing strategies, messages, and participate in viewing mood-boards and video-storyboards using these messages. A trained facilitator will follow a standardized discussion guide to lead the focus groups.
These activities will occur sequentially over about 6 months. At the 6-month time point, the study team will have met the study's primary aim of having developed the e-cigarette counter-marketing lesson.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Working group members | – | Other: Working group10 members of the expert working group: 2 middle school students, 2 high school students, 2 young adults, 1 educator, 1 parent, and 4 curriculum design expert |
| Focus group participants | – | Other: Focus group36 adolescent/young adult participants |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include individuals residing in the U.S. There will be 10 members of the expert working group (2 middle, 2 high school students, 2 young adults, 1 educator, 1 parent, and 4 curriculum design experts). There will be 36 adolescent and young adult participants of the focus groups.
Key inclusion criteria (17 listed)
- Middle school students may be 13-15 years
- High schoolers may be 16-18 years
- Young adults may be 19-29 years
- Provide a phone number for at least one backup contact (e.g, parent/guardian)
- Experience of at least 1 year in tobacco prevention or relevant public health field
Key exclusion criteria (2 listed)
- Express inability to participate consistently across study working group meetings.
- FOCUS GROUP PARTICIPANTS
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 |
|---|---|---|
| Working groupParticipants will: 1) take a 10-min demographic survey; 2) join 3 x 60-min working group meetings in which they will review preliminary results, collaborate on curriculum design, and provide feedback; and 3) respond to prompts in 3 emails (approx 5-10 mins each). | Other | Working group members |
| Focus groupParticipants will take a 10-min demographic survey and join 1 x 30-min focus group meeting in which they will provide feedback on the curriculum in development. | Other | Focus group participants |
Primary outcome
Development of an e-cigarette counter-marketing lesson focused on the retail environment
Time frame: At 6 months
Key messages and message-delivery strategy will be developed, potentially comprising of short-form videos. The study team will ask working group members to rank draft messages and strategies for delivery in addition to eliciting qualitative information.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: Yes. De-identified participant survey data will be made available.
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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.
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?
An observational study of E-cigarette and Vaping, run by Boston Children's Hospital 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 17 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 19 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Development of an e-cigarette counter-marketing lesson focused on the retail environment (time frame: At 6 months). 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 19 Aug 2025.