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Testing ANSOS for Efficacy in Multi-Tribal Urban Communities

Testing All Nations Snuff Out Smokeless (ANSOS) for Efficacy in Multi-Tribal Urban Communities

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06566703
Enrollment
384
Registered
2024-08-22
Start date
2023-08-18
Completion date
2026-08-18
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smokeless Tobacco Cessation

Keywords

American Indian, smokeless tobacco cessation

Brief summary

This is a wait-list control trial to test for efficacy of the All Nations Snuff Out Smokeless (ANSOS) recreational tobacco cessation program in multi-tribal American Indian (AI) communities. Participants randomized to the control arm are provided with a Healthy Living educational intervention while they wait for the program to encourage them to remain engaged with the study team during the six-month waiting period. Participants from the ANSOS arm are offered the Healthy Living educational intervention after they complete the 6-month outcome measures.

Detailed description

All Nations Snuff Out Smokeless (ANSOS) is a culturally tailored, group-based quit smokeless tobacco (SLT) program for American Indian (AI) people. Intervention components are described below. Group Support Sessions: The primary component of ANSOS are four group-based support sessions, led by an AI facilitator, conducted via Zoom. All group sessions begin with team building and discussion about things people are experiencing in their lives, both those related directly to recreational tobacco use and other things that help or hinder quit attempts. The first group session is devoted to forming a cohesive group and learning about individual journeys with tobacco. Additional group sessions focus on topics covered in the education curriculum. Individual Telephone Counseling: After initial group sessions, facilitators call participants weekly to see how they are doing, discuss personal issues related to the quitting process, and to remind them of the next group. Educational Curriculum: The ANSOS curriculum includes 11 brochures, given throughout the program; it combines cessation information with cultural elements. Topics covered include substantial information about tobacco as a sacred plant for many, though not all, AI tribes, historical trauma, and medical/research mistrust issues, among other topics related to how to effectively quit using recreational tobacco products. Educational materials for this project will be given to participants electronically via pdf documents. Healthy Living is an educational program primarily designed to maintain the interest of participants in the control arm in continuing into the ANSOS program after their 6-month waiting period. It includes group-based educational discussion about healthy diet, exercise, and stress management, along with educational materials on these topics. Participants also receive individual discussion with program facilitators in between group sessions.

Interventions

BEHAVIORALAll Nations Snuff Out Smokeless

All Nations Snuff Out Smokeless is a culturally tailored smokeless tobacco cessation program that incorporates group-based and individual counseling.

BEHAVIORALHealthy Living

Healthy Living is an educational program that provides information about diet, exercise, stress, and general health. It uses group-based and individual discussion, along with educational materials.

Sponsors

American Cancer Society, Inc.
CollaboratorOTHER
Lehigh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age 18 and over * Stable telephone number that can be used for the purpose of the study * Willing to be followed for 12 months and participate in study activities * Able to attend Zoom sessions * Current SLT user, at least once per day * Self-reported AI

Exclusion criteria

* Cannot provide a stable phone number for 12 months for the purpose of the study * Unable to attend Zoom sessions

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with 7-day point prevalence abstinence6 months7-day point prevalence abstinence from smokeless tobacco product use

Secondary

MeasureTime frameDescription
Number of participants with continuous abstinence6 months, 12 monthsContinuous abstinence from smokeless tobacco product use

Countries

United States

Contacts

Primary ContactChristine M Daley, PhD
cmdaley@lehigh.edu610-758-1878
Backup ContactRyan Goeckner, PhD
rtgoeckner@gmail.com610-758-3435

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026