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Faith Based Pilot Intervention to Reduce Tobacco Use Among Somali Males

2020年9月2日 更新者：University of Minnesota

1.1 In the last five years, representatives of WellShare International and the University of Minnesota have engaged a large community of Muslims of Somali descent in the Twin Cities of Minnesota in a community-academic research program to understand smoking and cessation behaviors. This followed research by WellShare International which discovered a smoking prevalence among Somali men of 44%, which is nearly three times that of the general population (14.4%) in Minnesota. More recently, pilot data from ecological momentary assessments (EMA) conducted by WellShare International and the University of Minnesota Program in Health Disparities Research before and during Ramadan, showed that the majority of smokers achieved spontaneous significant reductions in cigarettes smoked per day during Ramadan. Guided by the NIH Stage Based Intervention Development Model, this study aims to understand the processes underlying smoking reduction and cessation during Ramadan. The investigators plan to harness this knowledge and develop a culturally-tailored, faith-based smoking cessation intervention (Stage 1). The investigators also plan to assess the feasibility of the new culturally-tailored smoking cessation intervention by conducting a pilot study (Stage 2).

The study aims are as follows:

Aim 1: To develop a faith-based, community-informed innovative smoking cessation intervention for use with a Somali immigrant population in Minnesota:

Aim 2: To assess the feasibility of a faith-based smoking cessation intervention delivered via a mobile phone during the Ramadan period:

This pilot study will test a protocol for use of faith based text messages, as informed by the scholarly work of the Imams, Community Advisory Group (CAG) and focus groups conducted in Stage 1.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Smoking Prevalence in the Muslim communities: Although significant declines in cigarette smoking prevalence have been realized in the United States (U.S.), this decline is not universal. Muslim communities continue to have disproportionately high smoking prevalence rates. For example, one of WellShare International's studies showed a smoking prevalence rate of 44.1% among Somali adult (predominantly Muslim) men in Minnesota, compared to the average smoking rate for adult men in Minnesota (14.4%) and in the United States of 17.8%. Despite ample evidence that pharmacotherapy and counselling are effective for smoking cessation in the general population, no one has identified effective ways to extend these benefits to the Muslim communities and the U.S.'s largest Somali population which resides in Minnesota. Even when readily available, such aids seem to be underutilized, reflecting the commonly held belief among Muslims that giving up smoking primarily requires only will power. Although approaches that draw on the need for will power around the Ramadan fast (during which smoking is prohibited during daylight hours) have been considered, no systematic attempt has been made to make effective evidence-based smoking cessation methods available leveraged on the Ramadan. Muslim smokers face yet another challenge during the holy month of Ramadan, where adherence to medications during this month has been documented as challenging. However, because cigarette smoking continues to be the leading cause of morbidity and mortality, it is critical to identify evidence-based methods for promoting adherence to known effective methods for reducing tobacco related health disparities in this underserved minority population in Minnesota.

研究类型

介入性

注册 (实际的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Minnesota
      • Minneapolis、Minnesota、美国、55412
        • University of Minnesota
      • Minneapolis、Minnesota、美国、55414
        • WellShare International

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 79年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Somali Male
  • 18 years of age or older
  • Can read either Somali or English (Non English Speaking Participants will be included)
  • Current smokers defined as smoking ≥ 1 cigarette per day
  • Self-report of smoking ≥ 100 cigarettes in their lifetime
  • Willingness to use nicotine patch or other selected pharmacotherapy
  • Possess a working mobile phone with texting
  • Planning to fast during Ramadan

Exclusion Criteria:

  • Currently using any form of smoking cessation service
  • Any medical contraindication
  • Current history or in past 6 months of a psychotic disorder
  • Suicidal ideation
  • Cognitive impairment
  • Any other medical condition that, in the opinion of the investigator, may interfere with the patient's ability to successfully and safely complete the study

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：卫生服务研究
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
其他：Behavioral: Faith-Based messages
We will send faith-based messages one week prior to Ramadan and twice a day during Ramadan.
行为的：Faith-Based messages
We will send out faith based text messages on a weekly basis for the one week prior to the start of Ramadan, then twice a day during the Ramadan period that will encourage smoking cessation and continue to encourage change of behavior. The faith-based messages will be incorporated with messages drawn from the Smokefree.gov Mobile Interventions QuitNowTXT Message Library. These messages will be geared towards reminding the smokers that as Ramadan is coming closer they need to consider the effects that smoking may have on their health and should consider taking steps towards quitting.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Participants Adherence to the Intervention
大体时间：8 weeks
Real time smoking cravings and urges, as well as the number of cigarettes smoked in each time period, will be measured via ecological momentary assessment (EMA) in a sample of Muslim male smokers who are fasting during Ramadan. Participants will be enrolled in this study if they are current smokers and are going to fast throughout Ramadan. Analyses will use data collected via a RedCap survey at random time points (3 times per day, 2 times a week) during Ramadan. In the analysis, 4 time blocks (pre sunrise [4:30am-9:00am], day time [9:01am-3:00pm], pre sunset [3:01pm-9:00pm] and breaking fast [9:01pm-4:29am]) will be used for analysis.
8 weeks

次要结果测量

结果测量
措施说明
大体时间
smoking cessation
大体时间：8 weeks
CO breath test at week 4 and week 8
8 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Minnesota

调查人员

  • 首席研究员：Olamide Ojo-Fati, MD MPH、University of Minnesota

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年12月30日

初级完成 (实际的)

2018年9月21日

研究完成 (实际的)

2019年12月21日

研究注册日期

首次提交

2017年11月29日

首先提交符合 QC 标准的

2017年12月14日

首次发布 (实际的)

2017年12月20日

研究记录更新

最后更新发布 (实际的)

2020年9月4日

上次提交的符合 QC 标准的更新

2020年9月2日

最后验证

2020年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • FMCH-2017-25736

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

Faith-Based messages的临床试验

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赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Türkiye

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

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