A Web-Based Text Messaging for Tobacco Cessation in Rural Mississippi

Официальное название

A Randomized Trial of a Web-Based Text Messaging for Tobacco Cessation in Rural Mississippi

Обзор

Cigarette smoking prevalence has decreased to \~12% in 2022; however, over 40 million U.S. adults were current cigarette smokers in the same year. Rural-urban disparities in tobacco use are persistent, with higher tobacco use and lower cessation in rural areas. Less research has been dedicated to addressing rural-urban tobacco use disparities, perhaps due to logistics, difficulty recruiting and following participants from rural areas, and challenges with conducting clinic-based interventions. Mississippi is one of the states with higher rurality, as 79% of Mississippi counties are classified as rural. Additionally, Mississippi has a higher prevalence of tobacco use and lower cessation rates compared with the national average. Moreover, Mississippi is one of the few states that did not expand Medicaid, which covers comprehensive tobacco cessation services. This may add to the persistent disparity in tobacco use and cessation between rural and urban Mississippians. To overcome these challenges, the investigators propose a randomized clinical trial to test the effectiveness of theory-driven text messaging for tobacco cessation in rural Mississippi among users of cigarettes, smokeless tobacco (SLT), and dual users of cigarettes and SLT. Specifically, this proposal has the following specific aims: (1) To conduct a two-arm, randomized, clinical trial (RCT) of a web-based, text messaging approach for tobacco cessation among cigarette smokers, SLT users and dual users from rural Mississippi; (2) To assess the effectiveness of a web-based, text messaging intervention on tobacco cessation among cigarette smokers, SLT users and dual users; and (3) To identify barriers to and facilitators of tobacco cessation using ecological momentary assessment (EMA). To achieve these aims, a sample of 150 tobacco users (50 cigarette smokers, 50 SLT users, 50 dual users) who intend to quit and have made ≥1 quit attempt in the past 6 months will be recruited via a web-based, crowdsourcing platform (ResearchMatch.org). ResearchMatch.org is a large crowdsourcing platform that facilitates recruitment of a desired research sample from an online panel. Eligible participants will be randomized to intervention and control arms and will be asked to set up a quit date within the first 4 weeks post-intervention. Participants in the intervention arm will receive up to 3 motivational text messages daily during the first 4 weeks, and up to 2 daily during the last 2 weeks. The same frequency will be followed for the control group, but they will receive non-specific text messages. Participants will also receive a daily, midday text message during weeks 1-10 post-intervention to document the barriers and facilitators of tobacco cessation using EMA approach. After week 10 and to the end of 6 months post-intervention, the frequency of EMA texts will be reduced to once per week. Two-way text messaging will be facilitated via a web-based service called Mosio. The investigators will assess prolonged and 7-day point prevalence abstinence at 6 weeks, 3 months, and 6 months post-intervention. This project represents an attempt to test a simple and innovative approach to reducing rural-urban tobacco use disparities and overall tobacco-related morbidity and mortality. The findings can facilitate applying for extramural funding for a larger trial.

Вмешательства

• Поведенческое Motivational text messaging for tobacco cessation
  Participants will receive motivational text messaging for tobacco cessation.
• Поведенческое Non-specific text messaging
  Non-specific text messaging

Первичные конечные точки

• Prolonged abstinence [Срок оценки: Baseline to 6 months post-randomization]
• 7-day point prevalence abstinence [Срок оценки: Past 7 days]

Вторичные конечные точки (1)

• Prolonged abstinence of all tobacco products [Срок оценки: Baseline to 6 months]

Критерии участия

Критерии включения

• ≥18 years-old
• resident of rural Mississippi (verified by a ZIP code)
• not planning to move out of Mississippi during the next 6 months
• own a personal cellphone with an unlimited texting plan
• having the intention to quit tobacco and having made at least 1 quit attempt in the past 6 months
• smokes ≥5 cigarettes per day during the past 6 months (for the cigarette smoking condition)
• uses SLT ≥3 times per day during the past 6 months (for the SLT condition)
• concurrent use of cigarettes and SLT on ≥15 days monthly during the past 6 months (for the dual use condition).

Критерии исключения

• a self-report of being diagnosed with or taking medications for severe mental illness
• refusal to provide informed consent
• having no intention to quit tobacco
• currently using electronic cigarettes or pharmacological medications for tobacco cessation
• currently participating in another RCT.

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

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07431619 · UMMC-IRB-2024-453

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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