Testing ANSOS for Efficacy in Multi-Tribal Urban Communities
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: All Nations Snuff Out Smokeless, Healthy Living.
- Кому может быть актуально
- Состояния в реестре: Smokeless Tobacco Cessation. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Testing All Nations Snuff Out Smokeless (ANSOS) for Efficacy in Multi-Tribal Urban Communities
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое 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. - Поведенческое 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.
Первичные конечные точки
- Number of participants with 7-day point prevalence abstinence [Срок оценки: 6 months]
Вторичные конечные точки (1)
- Number of participants with continuous abstinence [Срок оценки: 6 months, 12 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- Cannot provide a stable phone number for 12 months for the purpose of the study
- Unable to attend Zoom sessions
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Lehigh University — Bethlehem
Идентификаторы
NCT: NCT06566703 · RSG-21-043-01-CPPB