Vape-Free Text-Messaging: Pilot Study

Not Applicable

Recruiting

• Conditions: E-cigarette Use

• Registration Number: NCT05906082
• Lead Sponsor: Seok Hyun Gwon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-25
• Study First Submitted: 2023-05-26
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants recruited and randomized	Throughout 12 months	Number of participants recruited and randomized
Retention rates (proportion of participants remained until 1 month post-intervention from enrollment)	At 1 month	Proportion of participants from enrollment to 1 month post-intervention or standard-care
Proportion of salivary cotinine samples returned	At 1 month	Proportion of salivary cotinine samples returned to the office lab for cotinine analysis
Concentration of cotinine in saliva	At 1 month	Biochemically verified abstinence evaluated by salivary cotinine samples
Nicotine dependence (Penn State Electronic Cigarette Dependence Index)	At 1 month	Nicotine dependence (minimum 0 to maximum 20, higher scores mean a worse outcome.)
Self-reported proportion of text messages read	At 1 month	Proportion of text messages read during the intervention or standard care at 1 month
Level of acceptability of the intervention	At 1 month	1. 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); 2. 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); 3. 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); 4. 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); 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)
Self-reported 7-days point prevalence abstinence from ENDS and other tobacco	At 1 month	Self-reported 7-days point prevalence abstinence from ENDS and other tobacco

Trial Locations

Locations (1)

University of Wisconsin-Milwaukee; 🇺🇸 Milwaukee, Wisconsin, United States