Improving Smoking Cessation in Socioeconomically-Disadvantaged Young Adults

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 1, 2020

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.

Interventions

  • Behavioral: Web + text smoking cessation intervention
    • Participants will receive referral to a quit smoking hotline and 12-week web and text-based smoking cessation intervention

Arms, Groups and Cohorts

  • Experimental: Web + text smoking cessation intervention
    • Participants will receive referral to a quit smoking hotline and 12-week web and text-based smoking cessation intervention
  • No Intervention: Usual care control
    • Participants will receive referral to a quit smoking hotline

Clinical Trial Outcome Measures

Primary Measures

  • 30-day point prevalence smoking abstinence
    • Time Frame: Assessed at 3-month follow-up
    • Self-reported smoking abstinence and biochemical validation (saliva cotinine)
  • 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
  • Intervention engagement
    • Time Frame: 12 weeks
    • Completing 75% or more of 12 weekly check-ins

Secondary Measures

  • 7-day point prevalence smoking abstinence
    • Time Frame: Assessed at 3-month follow-up
    • Self-reported smoking abstinence
  • Number of 24-hour quit attempts
    • Time Frame: Assessed at 3-month follow-up
    • Number of times intentionally stopped smoking cigarettes for 24 hours or longer because trying to quit
  • Perceived support to quit smoking
    • Time Frame: Assessed 3-month follow-up
    • 4 items pertaining to quit support from the text messages
  • Pattern and rate of tobacco/e-cigarette use
    • Time Frame: Assessed at 3-month follow-up
    • Past 30 (90 day) use of tobacco or nicotine products such as cigars, e-cigarettes, chewing tobacco, and nicotine replacement products

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Vermont
  • Collaborator
    • National Institute of General Medical Sciences (NIGMS)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andrea Villanti, Associate Professor – University of Vermont
  • Overall Official(s)
    • Andrea C Villanti, PhD, MPH, Principal Investigator, University of Vermont

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.