Vape-Free Text-Messaging: Pilot Study

Text-messaging E-cigarette Cessation Intervention for Young Adults in Rural Areas: A Pilot Study

This is a small pilot randomized controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of the e-cigarette cessation text-messaging intervention with young adults in rural areas.

Study Overview

• Status: Recruiting
• Conditions: E-cigarette Use
• Intervention / Treatment: Behavioral: E-cigarette cessation text-messaging intervention; Behavioral: Standard care control using standard national resources

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53211
      • Recruiting
      • University of Wisconsin-Milwaukee
      • Contact: Seok Hyun Gwon, PhD, RN; Phone Number: 414-229-6462; Email: gwon@uwm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• English speaking
• 18-24 years
• everyday e-cigarette use in the past month
• ownership of a mobile phone or smartphone with texting and internet access abilities
• knowledge of how to use text messages
• plan on quitting e-cigarette use within one month
• home address in a rural county of Wisconsin, Minnesota, North Dakota, and South Dakota

Exclusion Criteria:

• Individuals who reported use of other tobacco products (e.g., cigarettes, smokeless tobacco) than e-cigarettes in the past month

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention (E-cigarette cessation text-messaging intervention)	Behavioral: E-cigarette cessation text-messaging intervention; This is the intervention for e-cigarette cessation using text messages targeting young adults in rural areas.
Active Comparator: Standard care (Standard care control using standard national resources); This standard care group will receive standard care resources from smokefree.gov.	Behavioral: Standard care control using standard national resources; This is the standard care with national resources from smokefree.gov.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants recruited and randomized	Number of participants recruited and randomized	Throughout 12 months
Self-reported proportion of text messages read	Proportion of text messages read during the intervention or standard care at 1 month	At 1 month
Retention rates (proportion of participants remained until 1 month post-intervention from enrollment)	Proportion of participants from enrollment to 1 month post-intervention or standard-care	At 1 month
Level of acceptability of the intervention	When you had received our text messages from our VapeFreeTXT program 1 month ago, how many of our text messages did you read on a typical day? Not at all (1) Read about 25% messages (2) Read about half messages (3) Read about 75% messages (4) Read the entire messages (5); How useful was our VapeFreeTXT program in helping you quit vaping? Not at all useful (1) Slightly useful (2) Moderately useful (3) Very useful (4) Extremely useful (5); Did our VapeFreeTXT program make you think about quitting vaping? Not at all (1) Probably not (2) Neither yes nor no (3) Probably yes (4) Definitely yes (5); Do you think our VapeFreeTXT program will change your vaping? Not at all (1) Probably not (2) Neither yes nor no (3) Probably yes (4) Definitely yes (5); Would you recommend this program to a friend or others? Not at all (1) Probably not (2) Neither yes nor no (3) Probably yes (4) Definitely yes (5)	At 1 month
Proportion of salivary cotinine samples returned	Proportion of salivary cotinine samples returned to the office lab for cotinine analysis	At 1 month
Self-reported 7-days point prevalence abstinence from ENDS and other tobacco	Self-reported 7-days point prevalence abstinence from ENDS and other tobacco	At 1 month
Concentration of cotinine in saliva	Biochemically verified abstinence evaluated by salivary cotinine samples	At 1 month
Nicotine dependence (Penn State Electronic Cigarette Dependence Index)	Nicotine dependence (minimum 0 to maximum 20, higher scores mean a worse outcome.)	At 1 month

Collaborators and Investigators

• Sponsor: Seok Hyun Gwon

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 23.179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No