Recruiting

Quit Tobacco Program

Sponsor:

Morgan State University

Code:

NCT06053762

Conditions

Tobacco Product Use

Eligibility Criteria

Sex: All

Age: 14 - 21

Healthy Volunteers: Not accepted

Interventions

Peer-facilitated tobacco cessation

Self-navigated tobacco cessation

Study Details

Brief summary:

The proposed study is a randomized clinical trial. The overarching goal of the study is to apply Community Based Participatory Research (CBPR) to reduce tobacco use among youth and young adults (14-21 y/o) in Baltimore City through a mixed-method approach adapted to the needs of youth and young adults. This study has partnered with the American Lung Association's Not On Tobacco (N-O-T) program and aims to deliver tobacco cessation classes. The study will target Baltimore City high schools and colleges, prioritizing facilities in underserved inner-city communities. The proposed research consists of a 2-arm trial where participants from four high schools and two colleges will be randomized to peer-facilitated tobacco cessation classes or self-navigated groups. The trial aims to assess the effectiveness of peer-facilitated tobacco cessation intervention compared to self-navigated tobacco cessation in terms of their success rates (quitting and staying quit). The study's primary hypothesis is that the tobacco cessation rate will be equal to or higher in the peer-facilitated arm than in the self-navigated arms. The secondary hypothesis is that the retention rate will be equal to or higher in the peer-facilitated arm compared to the self-navigated arm.

CEASE Youth tobacco cessation program is an eight-week program based on the American Lung Association's (ALA) Not On Tobacco (N-O-T) program. The ALA's N-OT program is acknowledged as an accessible and effective option for teen tobacco cessation. Participants in the peer-facilitated group will be given the evidence-based N-O-T program curriculum and provided with virtual materials, information, and resources by their assigned peer facilitators. Virtual tobacco cessation peer motivation sessions will be offered using the digital online platform Zoom, and the peer facilitators will communicate with the participants in between the classes. The participants in the self-navigated group will receive the same ALA N-O-T program curriculum and complete the eight-week sessions, but it will be self-navigated and without peer facilitations. No peer facilitator will be assigned to this group, and the participants will complete the curriculum by themselves. They will also receive other available resources, including information about the local tobacco cessation services available.

Conditions

Tobacco Product Use

Study ID

NCT06053762

Start date

Oct 1, 2023

Status verified date

Mar, 2024

Completion date

Dec 1, 2024

Anticipated

Primary completion date

Sep 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Current tobacco user (have used any tobacco product over the past 30 days)
  • Individuals who are 14- 21 years old
  • Individuals who are ready and willing to quit using tobacco
  • Individuals who have access to a digital device (e.g., laptop/computer/tablet) with internet access or data

Exclusion Criteria:

  • Individuals who have health conditions preventing them from providing consent will be excluded from the study.

Study Design

Enrollment

630 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Peer-facilitated tobacco cessation

Peer-facilitated tobacco cessation: Participants will be given the evidence-based N-O-T program curriculum for tobacco cessation classes and provided with virtual materials, information, and resources by their assigned peer facilitators. Virtual tobacco cessation peer motivation sessions will be offered using the digital online platform Zoom, and the peer facilitators will communicate with the participants in between the classes Peer-facilitated tobacco cessation: Participants will be given the evidence-based N-O-T program curriculum for tobacco cessation classes and provided with virtual materials, information, and resources by their assigned peer facilitators. Virtual tobacco cessation peer motivation sessions will be offered using the digital online platform Zoom, and the peer facilitators will communicate with the participants in between the classes.

other: Self-navigated tobacco cessation

Self-navigated tobacco cessation: The participants in the self-navigated group will receive the same ALA N-O-T program curriculum and complete the eight-week sessions, but it will be self-navigated and without peer facilitations. No peer facilitator will be assigned to this group and the participants will complete the curriculum by themselves.

Interventions

Peer-facilitated tobacco cessation

Peer-facilitated tobacco cessation: Participants will be given the evidence-based N-O-T program curriculum for tobacco cessation classes and provided with virtual materials, information, and resources by their assigned peer facilitators. Virtual tobacco cessation peer motivation sessions will be offered using the digital online platform Zoom, and the peer facilitators will communicate with the participants in between the classes

Self-navigated tobacco cessation

Self-navigated tobacco cessation: The participants in the self-navigated group will receive the same ALA N-O-T program curriculum and will complete the eight-week sessions, but it will be self-navigated and without peer facilitations. No peer facilitator will be assigned to this group and the participants will complete the curriculum by themselves. Self-navigated tobacco cessation: The participants in the self-navigated group will receive the same ALA N-O-T program curriculum and will complete the eight-week sessions, but it will be self-navigated and without peer facilitations. No peer facilitator will be assigned to this group and the participants will complete the curriculum by themselves.

Primary outcome measure

  • Self-reported tobacco cessation [ Time Frame: Self-reported tobacco cessation: 3-5 months post-intervention. ]

Central Contacts and Locations

Central contacts

Locations

Morgan CARES

Recruiting

Baltimore, Maryland, United States, 21213

Contacts

More Information

Sponsor

Morgan State University

Last update posted

Mar 29, 2024

Last verified

Mar, 2024

Keywords

  • Tobacco cessation program, Community-based participatory research, Peer-facilitated approach, Youth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Morgan State University on 2024-03-29.