Improving Smoking Cessation in Socioeconomically-Disadvantaged Young Adults

NCT ID: NCT04379388

Last Updated: 2021-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

437 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-21

Study Completion Date

2020-10-15

Brief Summary

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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

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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.

Conditions

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Nicotine Dependence, Cigarettes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Web + text smoking cessation intervention

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

Group Type EXPERIMENTAL

Web + text smoking cessation intervention

Intervention Type BEHAVIORAL

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

Usual care control

Participants will receive referral to a quit smoking hotline

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Web + text smoking cessation intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

University of Vermont

OTHER

Sponsor Role lead

Responsible Party

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Andrea Villanti

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea C Villanti, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

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University of Vermont

Burlington, Vermont, United States

Site Status

Countries

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United States

Other Identifiers

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P20GM103644

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-0351

Identifier Type: -

Identifier Source: org_study_id

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