Clinical trial NCT04379388: Improving Smoking Cessation in Socioeconomically-Disadvantaged Young Adults
Official title: Improving Smoking Cessation in Socioeconomically-Disadvantaged Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence, Cigarettes
Keywords: smoking
smoking cessation
nicotine
nicotine dependence
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2020-05-07
Enrollment: 437
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 30-day point prevalence smoking abstinence
timeFrame: Assessed at 3-month follow-up
measure: Self-efficacy to quit smoking
timeFrame: Assessed at 3-month follow-up
measure: Intervention engagement
timeFrame: 12 weeks
Secondary outcomes:
measure: 7-day point prevalence smoking abstinence
timeFrame: Assessed at 3-month follow-up
measure: Number of 24-hour quit attempts
timeFrame: Assessed at 3-month follow-up
measure: Perceived support to quit smoking
timeFrame: Assessed 3-month follow-up
measure: Pattern and rate of tobacco/e-cigarette use
timeFrame: Assessed at 3-month follow-up
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Andrea C Villanti, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: