Vape-Free Text-Messaging: Pilot Study

Study Overview
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Brief Summary
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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.

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

Conditions
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E-cigarette Use

Intervention / Treatment
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* Behavioral: E-cigarette cessation text-messaging intervention
* Behavioral: Standard care control using standard national resources


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |