NCT04764175

Brief Summary

This project formally test an individual, telephone-based version of the All Nations Breath of Life smoking cessation program (tANBL) for American Indians (AI) for efficacy versus an untailored comparison program (CP). The primary outcome is 7-day point prevalence abstinence from smoking cigarettes at 6 months post-baseline. Secondarily, the study examines continuous abstinence and reduction in smoking at both 6 and 12 months post-baseline, as well as demographic predictors of cessation and/or reduction.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

May 13, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

3.7 years

First QC Date

February 17, 2021

Last Update Submit

June 25, 2025

Conditions

Smoking Cessation

Keywords

American IndianTelephone-BasedCommunity-Based Participatory ResearchBehavioral Intervention

Outcome Measures

Primary Outcomes (1)

  • Cessation

    7-day point prevalence abstinence from smoking cigarettes

    6 months

Secondary Outcomes (3)

  • Cessation

    12 months

  • Continuous Cessation

    6 months, 12 months

  • Smoking Change

    6 months, 12 months

Study Arms (2)

Telephone All Nations Breath of Life

EXPERIMENTAL

This is a culturally targeted smoking cessation program developed for American Indian communities. It includes individual telephone counseling, text messaging, and educational materials.

Behavioral: Telephone All Nations Breath of Life

Comparison Program

ACTIVE COMPARATOR

This is a non-culturally targeted smoking cessation program. It includes individual counseling, text messaging, and educational materials.

Behavioral: Comparison Program

Interventions

Telephone All Nations Breath of LifeBEHAVIORAL

Same as described above.

Also known as: tANBL
Telephone All Nations Breath of Life
Comparison ProgramBEHAVIORAL

Same as described above.

Also known as: CP
Comparison Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Self-reported American Indian
  • Smokes at least 1 cigarette per day
  • Have a home address or stable address to which we can mail program supplies
  • Have a stable telephone number that can be used for the purpose of the study
  • Willing to be followed for 12 months

You may not qualify if:

  • Cannot provide a stable phone number for the purpose of the study that will be available for a minimum of 12 months
  • Household member already in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lehigh University

Bethlehem, Pennsylvania, 18015, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Christine M Daley, PhD, MA, SM

    Lehigh University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Bayesian Adaptive Design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2021

First Posted

February 21, 2021

Study Start

May 13, 2021

Primary Completion

January 31, 2025

Study Completion

August 31, 2025

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)