Skip to main content
Clinical Trials/NCT04379388
NCT04379388
Completed
Not Applicable

Improving Smoking Cessation in Socioeconomically-Disadvantaged Young Adults

University of Vermont1 site in 1 country437 target enrollmentApril 21, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nicotine Dependence, Cigarettes
Sponsor
University of Vermont
Enrollment
437
Locations
1
Primary Endpoint
Self-efficacy to quit smoking
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to understand how to develop and deliver a better smoking cessation program for lower-income young adult smokers.

Detailed Description

Using content and strategy developed from the formative research phase, this randomized smoking cessation trial will test the impact of a tailored cessation intervention for socioeconomically-disadvantaged young adult (SDYA) smokers compared to a usual-care control on intervention engagement, self-efficacy to quit, and 30-day point prevalence abstinence at 3-month follow-up. This study will take place over a 3-month period. Individuals who complete the screening survey and are eligible to participate will be asked to complete a 15-20 minute baseline survey at the start of the study. This survey will ask questions about use of mobile phones, tobacco use, recent alcohol and other drug use, concerns about the coronavirus outbreak and how it may affect personal tobacco use, and physical activity. After the first survey, participants will be assigned randomly to one of two study groups: Group A: Referral to a quit smoking hotline (quit line) Group B: Referral to a quit smoking hotline (quit line), plus enrollment in a web and text-based smoking cessation intervention. Participants in both groups will be enrolled after completing the following steps, in order: 1. Providing consent to participate in the study; 2. Confirming contact information; 3. Completing a payment acknowledgement form that allows us to reimburse for survey/task completions; and 4. Completing the baseline survey. To complete enrollment, participants in Group B will also be required to register for an account on BecomeAnEx.org and enroll in text messages on the site. Once registered, Group B participants will be enrolled in a text message program customized for this study and will need to respond to the initial message from the text message platform to initiate text messages. Participants in Group B will receive daily text messages for 3 months with content delivered through the Truth Initiative's BecomeAnEx digital quit smoking platform. They will also receive brief (1-2 minute) weekly check-in surveys related to the week's messages and smoking status during this time. At 3-months, participants in both groups will receive the 15-minute follow-up assessment. Participants in both groups who report quitting smoking at 3-months will be mailed a kit in order to take a saliva test to measure the amount of cotinine, a metabolite of nicotine, in their saliva. Participants who report smoking at the 3-month follow-up will not receive this saliva test. All study procedures will take place remotely, with surveys conducted online. Participants in Group A will be paid at least $30 for participation and up to $80. Participants in Group B will be paid at least $40 for participation and up to $170.

Registry
clinicaltrials.gov
Start Date
April 21, 2020
End Date
October 15, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andrea Villanti

Associate Professor

University of Vermont

Eligibility Criteria

Inclusion Criteria

  • age 18-30
  • lives in the U.S.
  • smoked at least 100 lifetime cigarettes
  • currently smokes every day or some days
  • interest in quitting smoking within the next 6 months
  • subjective financial situation of just meeting or not meeting basic expenses
  • access to a smartphone with internet

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Self-efficacy to quit smoking

Time Frame: Assessed at 3-month follow-up

Confidence to quit within the next month (7days) on 0-10 scale

30-day point prevalence smoking abstinence

Time Frame: Assessed at 3-month follow-up

Self-reported smoking abstinence and biochemical validation (saliva cotinine)

Intervention engagement

Time Frame: 12 weeks

Completing 75% or more of 12 weekly check-ins

Secondary Outcomes

  • Pattern and rate of tobacco/e-cigarette use(Assessed at 3-month follow-up)
  • Number of 24-hour quit attempts(Assessed at 3-month follow-up)
  • Perceived support to quit smoking(Assessed 3-month follow-up)
  • 7-day point prevalence smoking abstinence(Assessed at 3-month follow-up)

Study Sites (1)

Loading locations...

Similar Trials