Testing ANSOS for Efficacy in Multi-Tribal Urban Communities

Conditions

• Smokeless Tobacco Cessation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Aug 18, 2023

Status verified

Aug 2024

Primary completion

Feb 18, 2026

Completion

Aug 18, 2026

Study Design

Enrollment

384 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.

Primary Outcome Measure

Number of participants with 7-day point prevalence abstinence [ Time Frame: 6 months ]

Central Contacts

• Christine M Daley, PhD
  610-758-1878
  [email protected]
• Ryan Goeckner, PhD
  610-758-3435
  [email protected]

Locations (1)

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