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Improving Smoking Cessation in Socioeconomically-Disadvantaged Young Adults

Improving Smoking Cessation in Socioeconomically-Disadvantaged Young Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04379388
Enrollment
437
Registered
2020-05-07
Start date
2020-04-21
Completion date
2020-10-15
Last updated
2021-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine Dependence, Cigarettes

Keywords

smoking, smoking cessation, nicotine, nicotine dependence

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.

Interventions

BEHAVIORALWeb + text smoking cessation intervention

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

Sponsors

National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH
University of Vermont
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
30-day point prevalence smoking abstinenceAssessed at 3-month follow-upSelf-reported smoking abstinence and biochemical validation (saliva cotinine)
Self-efficacy to quit smokingAssessed at 3-month follow-upConfidence to quit within the next month (7days) on 0-10 scale
Intervention engagement12 weeksCompleting 75% or more of 12 weekly check-ins

Secondary

MeasureTime frameDescription
7-day point prevalence smoking abstinenceAssessed at 3-month follow-upSelf-reported smoking abstinence
Pattern and rate of tobacco/e-cigarette useAssessed at 3-month follow-upPast 30 (90 day) use of tobacco or nicotine products such as cigars, e-cigarettes, chewing tobacco, and nicotine replacement products
Number of 24-hour quit attemptsAssessed at 3-month follow-upNumber of times intentionally stopped smoking cigarettes for 24 hours or longer because trying to quit
Perceived support to quit smokingAssessed 3-month follow-up4 items pertaining to quit support from the text messages

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026