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.

Study Overview

• Status: Completed
• Conditions: Nicotine Dependence, Cigarettes
• Intervention / Treatment: Behavioral: Web + text smoking cessation intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 437
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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
NO_INTERVENTION: Usual care control; Participants will receive referral to a quit smoking hotline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day point prevalence smoking abstinence	Self-reported smoking abstinence and biochemical validation (saliva cotinine)	Assessed at 3-month follow-up
Self-efficacy to quit smoking	Confidence to quit within the next month (7days) on 0-10 scale	Assessed at 3-month follow-up
Intervention engagement	Completing 75% or more of 12 weekly check-ins	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Vermont
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Andrea C Villanti, PhD, MPH, University of Vermont

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 21, 2020
• Primary Completion (ACTUAL): October 1, 2020
• Study Completion (ACTUAL): October 15, 2020

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (ACTUAL): May 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: smoking; nicotine dependence; smoking cessation; nicotine
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 17-0351; P20GM103644 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No