NCT06269003

Brief Summary

The goal of this clinical trial is to use psychophysiological methods to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

February 18, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 1, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

January 17, 2024

Results QC Date

June 3, 2025

Last Update Submit

July 14, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual Attention

    Visual attention was assessed by measuring dwell time, which is the length of time participants spent on looking at the specific areas of interest (AOIs) collected in miliseconds. Dwell time values were collected for 18 messages, and aggregated to provide the average dwell time scores for each arm. This was done for each vaping status (current vapers and susceptible non-vapers). Higher dwell time scores indicate higher visual attention, indicating better message outcomes.

    The entire duration of message from beginning of its delivery to the completion of viewing, up to 45 minutes.

  • Allocation of Cognitive Resources

    Heart rate values were collected in beats per minute (BPM) on a per-second basis during the presentation of each 18 distinct messages as well as during the immediately preceding black screen (baseline) for each message. Descriptive statistics were used to summarize changes in the BPM values during the message exposure period by comparing the BPM values collected during each message second to the BPM values collected during the immediately preceding baseline period. These change scores were then averaged across all messages within each study arm to generate a mean BPM value per condition, and this was done for each vaping status (current vapers and susceptible non-vapers). Lower BPM values reflect greater cognitive response, therefore indicate better message outcomes.

    Baseline and immediately after viewing all the messages (approximately 45 minutes).

  • Arousal

    Galvanic Skin Response (GSR) values were recorded in microsiemens on a per-second basis during the presentation of each 18 distinct messages as well as during the immediately preceding black screen (baseline) for each message. Descriptive statistics were used to summarize changes in GSR values by comparing each message response to its preceding baseline period. These change scores were then averaged across all messages within each study arm to generate a mean GSR score per condition, and this was done for each vaping status group (current vapers and susceptible non-vapers). Higher GSR values reflect greater physiological arousal, and indicate better message outcomes.

    Baseline and immediately after viewing all the messages (approximately 45 minutes).

Secondary Outcomes (2)

  • Attitudes

    After exposure to all messages, approximately up to 45 minutes.

  • Behavioral Intentions

    After exposure to all messages, approximately up to 45 minutes.

Study Arms (4)

Expert, one-sided

EXPERIMENTAL

Participants assigned to the expert, one-sidedness condition will receive one-sided e-cigarette messages from an expert source.

Other: Expert, one-sided

Expert, two-sided

EXPERIMENTAL

Participants assigned to the expert, two-sidedness condition will receive two-sided e-cigarette messages from an expert source.

Other: Expert, two-sided

Peer, one-sided

EXPERIMENTAL

Participants assigned to the peer, one-sidedness condition will receive one-sided e-cigarette messages from a peer source.

Other: Peer, one-sided

Peer, two-sided

EXPERIMENTAL

Participants assigned to the peer, two-sidedness condition will receive two-sided e-cigarette messages from a peer source.

Other: Peer, two-sided

Interventions

Participants will view a brief description of an expert source and see one-sided e-cigarette education messages.

Expert, one-sided

Participants will view a brief description of an expert source and see two-sided e-cigarette education messages.

Expert, two-sided

Participants will view a brief description of a peer source and see one-sided e-cigarette education messages.

Peer, one-sided

Participants will view a brief description of a peer source and see two-sided e-cigarette education messages.

Peer, two-sided

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 18-24
  • Fluent in English
  • Either vaping in the past 30 days or not having vaped in the past 30 days but susceptible to vaping
  • Self-reported abstinence of combusted tobacco or marijuana at time of visit

You may not qualify if:

  • Ages below 18 or above 24
  • Not fluent in English
  • Not confirmed self-reported abstinence of combusted tobacco or marijuana at time of visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMass Chan Medical School Shaw Building

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

SmokingBehavior

Results Point of Contact

Title
Donghee Nicole Lee, Assistant Professor
Organization
University of Hawaii Cancer Center

Study Officials

  • Donghee N Lee, PhD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 17, 2024

First Posted

February 21, 2024

Study Start

February 18, 2024

Primary Completion

June 10, 2024

Study Completion

June 10, 2024

Last Updated

August 1, 2025

Results First Posted

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations