Testing ANSOS for Efficacy in Multi-Tribal Urban Communities

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

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.

Study Overview

• Status: Recruiting
• Conditions: Smokeless Tobacco Cessation
• Intervention / Treatment: Behavioral: All Nations Snuff Out Smokeless; Behavioral: Healthy Living

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.

• Study Type: Interventional
• Enrollment (Estimated): 384
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine M Daley, PhD; Phone Number: 610-758-1878; Email: cmdaley@lehigh.edu
• Study Contact Backup: Name: Ryan Goeckner, PhD; Phone Number: 610-758-3435; Email: rtgoeckner@gmail.com

Study Locations

• United States
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • Recruiting
      • Lehigh University
      • Contact: Christine M Daley, PhD; Phone Number: 610-758-1878; Email: cmdaley@lehigh.edu
      • Contact: Ryan Goeckner, PhD; Phone Number: 610-758-3435; Email: rtgoeckner@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All Nation Snuff Out Smokeless; 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.	Behavioral: All Nations Snuff Out Smokeless; All Nations Snuff Out Smokeless is a culturally tailored smokeless tobacco cessation program that incorporates group-based and individual counseling.; Behavioral: Healthy 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.
Experimental: Wait List Control - Healthy Living; 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.	Behavioral: All Nations Snuff Out Smokeless; All Nations Snuff Out Smokeless is a culturally tailored smokeless tobacco cessation program that incorporates group-based and individual counseling.; Behavioral: Healthy 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with 7-day point prevalence abstinence	7-day point prevalence abstinence from smokeless tobacco product use	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with continuous abstinence	Continuous abstinence from smokeless tobacco product use	6 months, 12 months

Collaborators and Investigators

• Sponsor: Lehigh University
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Christine M Daley, PhD, Lehigh University

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2023
• Primary Completion (Estimated): February 18, 2026
• Study Completion (Estimated): August 18, 2026

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: American Indian; smokeless tobacco cessation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Respiratory System Agents; Lobeline
• Other Study ID Numbers: RSG-21-043-01-CPPB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No