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

NCT05181072 | Completed DMC

• 2 other identifiers: #19/06-00825U54MD013376
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Smoking cessation program; Community-based participatory research; Peer-based approach; underserved population

Outcome Measures

Primary Outcomes (2)

• Self-reported smoking cessation verified by expired-air Carbon Monoxide (CO) level (virtual and in-person groups).

  Self-reported smoking cessation verified by expired-air Carbon Monoxide (CO) levels. This will be measured using the CO breath monitor. Levels less than 8ppm will be considered as quit.

  week19 from enrollment (12 weeks after the last peer-motivation session)

• Self-reported smoking cessation verified by expired-air Carbon Monoxide (CO) level (self-help group).

  Self-reported smoking cessation verified by expired-air Carbon Monoxide (CO) levels. This will be measured using the CO breath monitor. Levels less than 8ppm will be considered as quit.

  week12 from enrollment

Secondary Outcomes (1)

• Retention

  Week 7

Study Arms (3)

Enhanced in-person peer-motivation

EXPERIMENTAL

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: Enhanced in-person peer-motivation smoking cessation

Virtual peer-motivation

EXPERIMENTAL

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.

Behavioral: Virtual peer-motivation smoking cessation

Self-help/Control

NO INTERVENTION

The participants in the control group will receive the services already in place, including a brief motivation enhancement session.

Interventions

Enhanced in-person peer-motivation smoking cessation BEHAVIORAL

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.

Enhanced in-person peer-motivation

Virtual peer-motivation smoking cessation BEHAVIORAL

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

Virtual peer-motivation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who are 21 years and above
• Current smokers
• Willing and ready to quit using tobacco, and consent to participate
• Access to devices (desktop, laptop, tablets, etc) with reliable and consistent internet access or cellular data (to participate in the virtual intervention)

You may not qualify if:

• Individuals who have health conditions preventing them from providing consent
• Individuals in communities randomized to the virtual intervention with no access to smartphones with internet access or cellular data

Sponsors & Collaborators

• Morgan State University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Morgan CARES

Baltimore, Maryland, 21213, United States

Location

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Related Links

• Burden of Tobacco Use in the U.S.
• JHSPH Human Subjects Research Ethics Field Guide

MeSH Terms

Conditions

Cigarette Smoking; Tobacco Use

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: January 6, 2022
• Study Start: January 5, 2022
• Primary Completion: December 23, 2023
• Study Completion: December 23, 2023
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)