Young Adult EC Use and Respiratory Outcomes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-15

Study Completion Date

2024-02-21

Brief Summary

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E-cigarette (EC) use continues to increase among youth, and EC may be detrimental to youth respiratory health. Public health officials and the Food and Drug Administration (FDA) can now regulate ECs. The proposed study uses naturalistic assessments called ecological momentary assessment (EMA) to understand how ECs use may impact the respiratory health of youth and young adult users compared to never-using peers.

Detailed Description

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Using a prospective longitudinal design, 150 youth and young adults aged 18-25 years (100 exclusive-EC users; 50 never-users) will complete 5 sessions (baseline, 3-,6-, 9-, and 12-months). Sessions will include naturalistic measures such as measures of respiratory health, questionnaires, and nasal epithelial lining fluid (NELF) nasal samples. To assess acute changes in pulmonary functioning related to tobacco product use, participants will complete twice daily EMA and home-based spirometry for the 2 weeks following the Day 1 session and the 2 weeks prior to each follow-up zoom session. Never-users will participate in a brief 15-30-minute individual interview consisting of questions related to reasons for never-EC use and other protective factors that will be used to build future prevention messaging.

Conditions

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E Cig Use

Keywords

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e-cigarette respiratory health prospective

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Current E-Cigarette Users

Monitoring current e-cigarette users

No interventions assigned to this group

Never E-Cigarette / Tobacco Users

Monitoring never users of any tobacco or e-cigarette products.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. own a smartphone and willing to add study EMA and spirometry application to it.
2. a current exclusive-EC user (endorse ≥weekly use over the past 3 months) and report never trying OTPs
3. between the ages of 18-25 years old at the time of enrollment
4. read and speak English
5. willing to complete five, 2-week periods of daily EMA and home-based spirometry
6. never-users must indicate never trying any tobacco product to be eligible for enrollment

Exclusion Criteria

1. self-reported diagnosis of lung disease including cystic fibrosis or chronic obstructive pulmonary disease; we will not exclude youth who have asthma, but will incorporate this as a covariate during analyses
2. unstable or significant psychiatric conditions (past and stable conditions will be allowed)
3. history of cardiac event or distress within the past 3 months
4. are currently pregnant, planning to become pregnant, or breastfeeding
5. are blind, severely visually impaired, deaf, hard of hearing, or have a severe motor disability

Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Alayna Tackett

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alayna Tackett, PhD

Role: PRINCIPAL_INVESTIGATOR

The Ohio State Comprehensive Cancer Center

Locations

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The Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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1K01HL148907-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2024-06207

Identifier Type: OTHER