Clinical trial NCT06566703: Testing ANSOS for Efficacy in Multi-Tribal Urban Communities
Official title: Testing All Nations Snuff Out Smokeless (ANSOS) for Efficacy in Multi-Tribal Urban Communities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smokeless Tobacco Cessation
Keywords: American Indian
smokeless tobacco cessation
Lead sponsor: Lehigh University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2024-08-22
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with 7-day point prevalence abstinence
timeFrame: 6 months
Secondary outcomes:
measure: Number of participants with continuous abstinence
timeFrame: 6 months, 12 months
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: Lehigh University
state: Pennsylvania
Study officials:
affiliation: Lehigh University
name: Christine M Daley, PhD
role: PRINCIPAL_INVESTIGATOR
References: