ClinicalTrials.gg
Enrolling by invitationNCT07129265Updated Aug 19, 2025

Understanding Vape Marketing Study

An observational study in E-cigarette, Vaping and Tobacco, sponsored by Boston Children's Hospital. Enrolling by invitation at 1 site in United States. Open to participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-19.

Sponsored by Boston Children's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
46
Ages
13 Years and older
Sex
All
01

Study 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, 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:

  1. 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.
  2. 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.

02

Conditions studied

  • E-cigarette
  • Vaping
  • Tobacco
  • Nicotine
  • Adolescent Behavior
  • Video Information
  • Digital Education Interventions

Keywords

  • e-cigarette
  • vaping
  • tobacco
  • nicotine
  • adolescent
  • counter-marketing
  • digital content
  • digital education interventions
03

In context

Vaping

402 studies on the registry are indexed under Vaping; 95 are open to participants now.

This study's planned enrollment of 46 is below the median of 120 across 65 observational studies indexed under Vaping.

Browse Vaping studies →

Lead sponsor

Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Eligibility criteria

WORKING GROUP MEMBERS

*Inclusion criteria

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:

  • 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

    *Exclusion criteria

  • Express inability to participate consistently across study working group meetings.

FOCUS GROUP PARTICIPANTS

*Inclusion criteria

  • 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
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
46 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    Other: Working group

  • Focus group participants

    36 adolescent/young adult participants

    Other: Focus group

Interventions

  • OtherWorking group

    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).

  • OtherFocus group

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At 6 months

Other outcomes

  1. Feasibility: Preferred recruitment advertisement

    Self-reported data and/or qualitative data elicited from participants by prompting: Which Instagram advertisement made you interested to join this study?

    Time frame: Baseline (pre-focus group)

  2. Acceptability: Relevance to population(s)

    Qualitative data elicited from participants by prompting: How participants feel about relevance to and representation of age group and e-cigarette use status (e.g., "this message is not for me since I don't vape" or "I would not be interested," helpfulness of content to achieve different tobacco prevention goals such as raising awareness, prevention)

    Time frame: During baseline focus group

  3. Acceptability: Desired improvements

    Qualitative data elicited from participants by prompting: How would you improve the messages? What changes would you make?

    Time frame: During baseline focus group

  4. Perceived influence of content: Awareness

    Qualitative data elicited from participants by prompting: How helpful was it to include \[key message in development\] to raise awareness about e-cigarettes and e-cigarette marketing?

    Time frame: During baseline focus group

  5. Perceived influence of content: Reducing appeal

    Qualitative data elicited from participants by prompting: How helpful was it to include \[key message in development\] to prevent adolescents from liking e-cigarette products?

    Time frame: During baseline focus group

  6. Perceived influence of content: Purchase behaviors

    Qualitative data elicited from participants by prompting: How helpful was it to include \[key message in development\] to prevent/reduce e-cigarette purchase?

    Time frame: During baseline focus group

  7. Perceived influence of content: Use prevention

    Qualitative data elicited from participants by prompting: How helpful was it to include \[key message in development\] to prevent/reduce adolescent e-cigarette use?

    Time frame: During baseline focus group

  8. Feasibility: Device used to access lessons

    Qualitative data elicited from participants by prompting: Device most commonly used to access similar online/video content

    Time frame: During baseline focus group

  9. Feasibility: Duration of engagement with components

    Average time in minutes to engage with draft messages, and study activities

    Time frame: During baseline focus group

  10. E-cigarette use

    A survey will ask participants, "Have you ever tried any of the following products, even one or two puffs?" (Yes/No). If "Yes," participants will see the question, "During the past 30 days, did you use any of the following products, even one or two puffs? (Yes/No)." If "Yes," participants will see the question, "On how many days out of the past 30 days, did you use a…" with a numeric response from 0-30 (drop-down option where participants could select only one response). If participants provided an answer from 1-30 to this question, the survey will ask, "In the past 7 days, on how many days did you use an e-cigarette or vape?" with a numeric response from 0-7 (drop-down option where participants could select only one response). (Products include:nicotine vape, THC (marijuana) vape, some kind of vape (don't know what was in it), cigarette, and nicotine pouch).

    Time frame: Baseline (pre-focus group)

  11. Susceptibility to Use E-cigarettes

    A survey will ask participants 4 questions adapted from the Enhanced susceptibility to smoking index, (1) "Have you ever been curious about e-cigarettes/vapes?; (2) "Do you think you will try an e-cigarette/vape in the next month?;" (3) Do you think you will try an e-cigarette/vape in the next year?; and (4) "If one of your best friends were to offer you an e-cigarette/vape, would you try it?" with responses on a 4-point Likert-type scale (Definitely yes; Probably yes; Probably not; and Definitely not). Across all 4 questions, any participant response except "Definitely not" will be classified as susceptible to using e-cigarettes.

    Time frame: Baseline (pre-Focus Groups)

  12. Acceptability: Perceptions of anti-vaping educational content or counter-marketing

    The facilitator will ask participants about perceptions of anti-vaping ads, specifically inside and around retail stores

    Time frame: During focus groups

  13. Marketing receptivity inside and around retail stores

    A survey and the focus group facilitator will ask about perceptions of e-cigarette brand recall among adolescents, appealing locations of advertising, ownership of merchandise, and receipt of free samples

    Time frame: At Baseline (pre-Focus groups) and During Baseline Focus Groups

  14. Feedback on counter-marketing messages

    The facilitator will ask participants: 1) Could you describe what was interesting or engaging? Probes: How would you improve what you just saw? What changes would you make? Comments on: a) individualized delivery; b) influencer-style; c) message? 2) Are there parts you would recommend excluding? Why? 3) How relevant was it to you? To people your age? 4) Was the language used easy to understand? 5) How does this messaging compare to what you have already seen? 6) How helpful was it to include the messages on marketing? a) raise awareness; b) prevent adolescents from liking products; c) prevent/ reduce e-cigarette purchase (in stores); d) prevent/ reduce e-cigarette purchase or sharing (with friends/family); and prevent/ reduce e-cigarette use? 7) If you were trying to prevent someone from starting to vape, what could be effective: a) aspects about vaping that you could bring up?; b) language that you could use?; c) images that you could use?; d) appeals that you could use?

    Time frame: During baseline focus groups

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — De-identified participant survey data will be made available.

Supporting information: Study protocol, Statistical analysis plan

Time frame: De-identified data will be made available only after study publication (between 14-24 months after the end of the study).

Access criteria: The Principal Investigator will provide data to those who indicate that they have received approval from an Institutional Review Board (IRB) or appropriate ethics committee, and execute a data use/sharing agreement.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Apr 2027, 20 months after the start.

Of 32 observational studies under Vaping, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 46. This study's planned 20 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2025
First posted
Aug 19, 2025
StartActual
Aug 4, 2025
Primary completionEst.
Apr 30, 2027
CompletionEst.
Apr 30, 2027
Last update
Aug 19, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07129265
Collaborators
National Cancer Institute (NCI), Dana-Farber/Harvard Cancer Center (DF/HCC) Boston, MA
Responsible party
Shivani Gaiha (Faculty Researcher, Boston Children's Hospital) — Principal investigator
First posted
Aug 19, 2025
Start date
Aug 4, 2025
Primary completion
Apr 30, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Aug 19, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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