Testing ANSOS for Efficacy in Multi-Tribal Urban Communities

Lehigh University

Status: Enrolling

Conditions: Smokeless Tobacco Cessation

Treatments: Behavioral: All Nations Snuff Out Smokeless; Behavioral: Healthy Living

Study type: Interventional

Funder types: Other

Identifiers

NCT06566703

RSG-21-043-01-CPPB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 384 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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384 participants in 2 patient groups

All Nation Snuff Out Smokeless

Experimental group

Description:

This is a culturally targeted smokeless tobacco cessation program developed for American Indian communities. It includes group sessions via Zoom, individual telephone counseling, and educational materials.

Treatment:

Behavioral: Healthy Living

Behavioral: All Nations Snuff Out Smokeless

Wait List Control - Healthy Living

Experimental group

Description:

Participants randomized to this arm are provided with information about healthy living while they wait for their turn at the intervention arm. Participants learn about diet, exercise, and stress reduction. They receive the All Nations Snuff Out Smokeless intervention after a six-month waiting period.

Treatment:

Behavioral: Healthy Living

Behavioral: All Nations Snuff Out Smokeless