PACE Vape Messaging Study | NCT04450537

Studies
PACE Vape Messaging Study

NCT04450537

Sponsor

University of Vermont

Status

Completed

Last Update Posted

Nov 3, 2020Actual

Enrollment

569Actual

Phase

Not Applicable

Conditions

Vaping
E-cigarette Use
Electronic Cigarette Use

Interventions

Vape Messaging Intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U54DA036114	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 23, 2020Actual

Primary Completion Date

Sep 30, 2020Actual

Completion Date

Sep 30, 2020Actual

First Submitted Date

Jun 23, 2020

First Submission Date that Met QC Criteria

Jun 26, 2020

First Posted Date

Jun 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2020

Last Update Posted Date

Nov 3, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrea Villanti, Associate Professor, University of VermontPrincipal Investigator

Lead Sponsor

University of VermontOTHER

Collaborators

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to examine the effect of exposure to vape education messages on beliefs, perceptions, norms, and behaviors related to electronic vapor product use.

Detailed Description

Using content developed from the formative research phase, participants in this randomized controlled trial will either be exposed to ten vape education messages or to ten messages on sun safety, with all messages formatted for social media.

This study will take place over a 1-month period. Individuals who complete the screening survey and are eligible to participate will be invited to complete a 10-15 minute baseline survey at the start of the study. This survey will ask questions about tobacco and electronic vapor product use, and beliefs about and perceptions of vape products. This survey will also ask about exposure to tobacco and e-cigarette marketing, exposure to prevention messaging on vaping and tobacco use, and peer and family influences on tobacco use. During the survey, participants will be presented with and be asked to provide feedback for short health-related messages.

One month after completing this survey, participants will be sent an invitation to the follow-up survey. This survey will again ask about tobacco and electronic vapor product use, and beliefs about and perceptions of vape products.

All study procedures will take place remotely, with surveys conducted online. At the end of the first survey, participants will be eligible to receive a $10 online gift card. Upon completion of the follow-up survey, participants will be eligible to receive a $15 online gift card. In total, participants will be eligible to receive up to $25 for completing both surveys. Those who are ineligible will not be asked to complete the baseline survey and will not be compensated.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

569Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vape Messaging Intervention	Experimental	Participants will be exposed to 10 vape education messages	Behavioral: Vape Messaging Intervention
Sun Safety Control	No Intervention	Participants will be exposed 10 sun safety messages

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vape Messaging Intervention	Behavioral	Participants will be exposed to 10 vape education messages	Vape Messaging Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nicotine/e-cigarette beliefs	True/false/don't know questions about nicotine and electronic vapor/tobacco products	Assessed at 1-month follow-up
Vape harm perceptions	Harm perception questions about use of electronic vapor/vape products	Assessed at 1-month follow-up
Vaping-related norms	Questions (5-point Likert scale: 1=Very negative, 5 = Very positive) about others' opinion of using electronic vapor/vape products like JUUL	Assessed at 1-month follow-up

Secondary Outcomes

Measure	Description	Time Frame
Behavioral intentions	Questions about intent to use electronic vapor/vape products in the next 12 months	Assessed at 1-month follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages 18-24
Vermont resident
Access to a smartphone with internet
Use of one or more social media site(s) at least weekly

Exclusion Criteria:

Aged 25 years or older
Not Vermont resident
No access to a smartphone with internet
Use of one or more social media site(s) less than weekly

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

24 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrea C Villanti, PhD, MPH	University of Vermont	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Vermont		Burlington	Vermont	05405	United States

Label	URL
Study website	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000072137	Vaping

Ancestor Terms

ID	Term
D012907	Smoking
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided