Urban and Reservation Implementation of All Nations Breath of Life
ANBL-I
Urban an Reservation Implementation of All Nations Breath of Life to Improve Smoking Cessation Rates Among American Indians
2 other identifiers
interventional
576
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2021
CompletedStudy Start
First participant enrolled
April 8, 2021
CompletedFirst Posted
Study publicly available on registry
June 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
ExpectedFebruary 4, 2025
January 1, 2025
4.9 years
February 17, 2021
January 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Smoking Cessation
Cessation measured by self-report and expired Carbon Monoxide (CO)
7-day point prevalence abstinence at 6 months
Secondary Outcomes (1)
Smoking Cessation 2
30-day point prevalence and continuous abstinence at 6 months
Study Arms (1)
All Nations Breath of Life
EXPERIMENTALANBL 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.
Interventions
Eligibility Criteria
You may qualify if:
- Self-identified American Indian or allowed to enroll by community site
- Age 18 or older
- Smokes at least one cigarette per day
- Planning to quit smoking
- Have a home address and telephone number
- Willing to be followed for 6 months
- Willing to participate
You may not qualify if:
- \- Any of the above do not apply
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lehigh Universitylead
- University of Kansas Medical Centercollaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Lehigh University
Bethlehem, Pennsylvania, 18015, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christine M Daley, PhD
Lehigh University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2021
First Posted
June 18, 2021
Study Start
April 8, 2021
Primary Completion
February 28, 2026
Study Completion (Estimated)
February 28, 2027
Last Updated
February 4, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share