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Completed

NCT Number: NCT04379388

Improving Smoking Cessation in Socioeconomically-Disadvantaged Young Adults

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

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont

Burlington, Vermont, 05405, United States

About this study

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:

  • Providing consent to participate in the study;
  • Confirming contact information;
  • Completing a payment acknowledgement form that allows us to reimburse for survey/task completions; and
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Web + text smoking cessation intervention

Behavioral

Participants will receive referral to a quit smoking hotline and 12-week web and text-based smoking cessation intervention

Primary outcomes

  1. 30-day point prevalence smoking abstinence

    Time frame: Assessed at 3-month follow-up

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

  2. 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

  3. Intervention engagement

    Time frame: 12 weeks

    Completing 75% or more of 12 weekly check-ins

Secondary outcomes

  1. 7-day point prevalence smoking abstinence

    Time frame: Assessed at 3-month follow-up

    Self-reported smoking abstinence

  2. 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

  3. Perceived support to quit smoking

    Time frame: Assessed 3-month follow-up

    4 items pertaining to quit support from the text messages

  4. 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

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 7, 2020
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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