Identify the Usefulness of In-person and Virtual Quit Smoking Programs

NCT05181072 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2024-03-29

No results posted yet for this study

Summary

This study is a randomized community-based trial adapted to the needs of adults aged 21 years or older that is designed by an existing research partnership called Communities Engaged and Advocating for Smoke-free Environments (CEASE). The overarching goal of the proposed study is to apply a community-based approach to reduce tobacco use among low-income communities in Baltimore City. The study setting represents three underserved communities in Baltimore City: the Oldtown/Middle East, the Waverlies, Poppleton/The Terraces/Hollins Market, and Washington Village/Pigtown. Poppleton/The Terraces/Hollins Market and Washington Village/Pigtown will be considered as one community. The three communities have been randomly allocated to one of the three arms of the study: 1) Virtual intervention, 2) Enhanced in-person intervention, and 3) The control community.

The Waverlies was assigned to virtual, the Middle East was assigned to be the in-person group, and Poppleton/The Terraces/Hollins Market and Washington Village/Pigtown became the self-help/control group. The goal of the trial is to assess the effectiveness of virtual versus in-person versions of a smoking cessation program in terms of their success rates (quitting and staying quit). The study's primary hypothesis is that the smoking cessation rate will be equal to or higher in the virtual peer-motivation arm than the in-person and self-help/ control arms. The secondary hypothesis is that the retention rate will differ among the three interventions (virtual peer-motivation, enhanced in-person peer-motivation, and self-help/control community).

Virtual and enhanced in-person versions of the CEASE Today Peer-Motivation Intervention were developed and pilot-tested during the first and second years based on local data and input from partnering communities. The enhanced in-person intervention will utilize the existing CEASE Today Tobacco Cessation Manual with improvements. The virtual intervention will use a newly developed CEASE website with smoking cessation modules and lessons that mirror the CEASE Today Tobacco Cessation Manual. Trained peer-motivators will deliver the intervention and be actively involved in recruiting the participants, motivation enhancement, group facilitation, and counseling.

Conditions

  • Cigarette Smoking
  • Tobacco Use

Interventions

BEHAVIORAL

Enhanced in-person peer-motivation smoking cessation

Tobacco cessation classes will be offered in-person for a total of five sessions delivered weekly for five weeks and will utilize the CEASE Today Tobacco This is a seven-week tobacco cessation program and will be offered in-person weekly for seven weeks and will utilize the CEASE Today Tobacco Cessation Manual.

BEHAVIORAL

Virtual peer-motivation smoking cessation

This is a seven-week tobacco cessation program and will be offered virtually (except first two sessions: orientation and technology set-up) weekly for seven weeks and will utilize a newly developed website with smoking cessation modules that mirrors lessons of the CEASE Today Tobacco Cessation Manual

Sponsors & Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH
  • Morgan State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-05
Primary Completion
2023-12-23
Completion
2023-12-23

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05181072 on ClinicalTrials.gov