Urban and Reservation Implementation of All Nations Breath of Life

Part of paid clinical trials in Bethlehem, Pennsylvania.

Sponsor
Lehigh University
Study ID
NCT04931810
Status
Recruiting
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Conditions

  • Smoking Cessation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • All Nations Breath of Life — BEHAVIORAL
    Same.

Study Details

This is an implementation trial of the All Nations Breath of Life (ANBL) smoking cessation program, which has already been tested for efficacy in reservation populations and shown feasibility in urban populations. It includes four implementation sites, two reservation sites and two urban sites. Therefore, investigators plan to test efficacy simultaneously. Implementation will follow guidelines described in the protocol, with all sites implementing certain parts of the intervention the same way, with the freedom to modify some aspects of the intervention for appropriate use in their communities. Statistical considerations are described in the appropriate section.

Key Dates

Start date
Apr 8, 2021
Status verified
Jan 2025
Primary completion
Feb 28, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
576 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All Nations Breath of Life
    ANBL is a culturally tailored smoking cessation program that incorporates group-based and individual counseling. Participants may elect to take pharmacotherapy, but are not required to do so.

Primary Outcome Measure

Smoking Cessation [ Time Frame: 7-day point prevalence abstinence at 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lehigh UniversityBethlehemPennsylvania18015
Christine M Daley, PhD
[email protected]
610-758-1878
Joseph Pacheco, MPH
[email protected]
816-944-1055

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