Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566703
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Testing ANSOS for Efficacy in Multi-Tribal Urban Communities
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Testing All Nations Snuff Out Smokeless ANSOS for Efficacy in Multi-Tribal Urban Communities
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 medicalresearch 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
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 medicalresearch 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None