Testing ANSOS for Efficacy in Multi-Tribal Urban Communities

NCT06566703 | Recruiting DMC

• 1 other identifier: RSG-21-043-01-CPPB
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

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.

Conditions

Smokeless Tobacco Cessation

Keywords

American Indian; smokeless tobacco cessation

Outcome Measures

Primary Outcomes (1)

• Number of participants with 7-day point prevalence abstinence

  7-day point prevalence abstinence from smokeless tobacco product use

  6 months

Secondary Outcomes (1)

• Number of participants with continuous abstinence

  6 months, 12 months

Study Arms (2)

All Nation Snuff Out Smokeless

EXPERIMENTAL

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; Behavioral: Healthy Living

Wait List Control - Healthy Living

EXPERIMENTAL

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; Behavioral: Healthy Living

Interventions

All Nations Snuff Out Smokeless BEHAVIORAL

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

All Nation Snuff Out Smokeless; Wait List Control - Healthy Living

Healthy Living BEHAVIORAL

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.

All Nation Snuff Out Smokeless; Wait List Control - Healthy Living

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lehigh University: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Lehigh University

Bethlehem, Pennsylvania, 18015, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Christine M Daley, PhD

  Lehigh University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine M Daley, PhD

CONTACT

610-758-1878; cmdaley@lehigh.edu

Ryan Goeckner, PhD

CONTACT

610-758-3435; rtgoeckner@gmail.com

Study Design

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

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: August 18, 2023
• Primary Completion: February 18, 2026
• Study Completion (Estimated): August 18, 2026
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)