BREATHE Free: a Pilot Feasibility Trial

NCT ID: NCT06862050

Last Updated: 2025-03-06

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

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-12-25

Brief Summary

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The overall purpose of this pilot study is to assess the feasibility and acceptability of an in-person faith-based intervention to help people stop tobacco use. The study will address use of different types of tobacco products, such as smoking combustible cigarettes, cigarillos and little filtered cigars, and using/vaping electronic nicotine delivery systems (vape pens, e-cigs, and JUUL).

The intervention consists of 12 weekly meetings in which participants will go through BREATHE Free, a study guide curriculum designed to teach character strengths and promote resilience. This pilot research will provide information and practical lessons on how to improve Breathe Free implementation, increase engagement of the local people, and maximize their benefit.

The main questions it aims to answer are:

* Do participants find BREATHE Free curriculum acceptable, engaging and helpful to stop tobacco use?
* Do participants who complete BREATHE Free curriculum smoke fewer cigarettes per day?

Researchers will assign participants to either BREATHE Free curriculum or usual care.

Participants will:

* Be taught BREATHE Free curriculum or be given information and referral to tobacco quit line
* BREATHE Free group will attend 12 group meetings held on the university campus
* All participants will answer interview questions related to tobacco use, character strengths and resilience
* Expired Carbon Monoxide (CO) will be assessed in all participants.

Detailed Description

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Conditions

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Smoking Cessation; Tobacco Dependence E-Cig Use Nicotine Dependence, Other Tobacco Product

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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BREATHE Free

Attend 12 in-person weekly meetings and go through Breathe Free curriculum.

Group Type EXPERIMENTAL

BREATHE Free Curriculum

Intervention Type BEHAVIORAL

Curriculum will teach practices: love, perspective, prudence, hope, humility, forgiveness, spirituality, self-control, teamworking, perseverance, gratitude, and joy.

Control

This group will serve as a control group and will receive usual care, referral to tobacco quit line.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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BREATHE Free Curriculum

Curriculum will teach practices: love, perspective, prudence, hope, humility, forgiveness, spirituality, self-control, teamworking, perseverance, gratitude, and joy.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Daily use of one or more tobacco products
* Valid home address in Augusta or the CSRA
* Functioning telephone number
* Speak, read, write in English

Exclusion Criteria

* Current use of tobacco cessation medications
* Enrolled in tobacco treatment program
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Ban Majeed

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Augusta University

Augusta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ban A Majeed, PhD

Role: CONTACT

7067210806

Facility Contacts

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Ban A Majeed, PhD

Role: primary

706-721-0806

Other Identifiers

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2051137

Identifier Type: -

Identifier Source: org_study_id

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