Faith Based Pilot Intervention to Reduce Tobacco Use Among Somali Males

NCT03379142 | Completed

• 1 other identifier: FMCH-2017-25736
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Tobacco Use; Faith-Based; Community-engaged; Text Messaging

Keywords

Faith-Based; Community-engaged; Text messaging; Tobacco

Outcome Measures

Primary Outcomes (1)

• Participants Adherence to the Intervention

  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

Secondary Outcomes (1)

• smoking cessation

  8 weeks

Study Arms (1)

Behavioral: Faith-Based messages

OTHER

We will send faith-based messages one week prior to Ramadan and twice a day during Ramadan.

Behavioral: Faith-Based messages

Interventions

Faith-Based messages BEHAVIORAL

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.

Behavioral: Faith-Based messages

Eligibility Criteria

• Age: 18 Years - 79 Years
• Gender Eligibility Details: Somali Male smokers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Somali Male
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (2)

University of Minnesota

Minneapolis, Minnesota, 55412, United States

Location

WellShare International

Minneapolis, Minnesota, 55414, United States

Location

Related Publications (1)

• Pratt R, Ojo-Fati O, DuBois D, Okuyemi K, Graham AL, Mohamed S, Janowiec M, Kahin A, Mahamud A, Tessier KM, Busch AM, Joseph AM. Testing the Feasibility and Acceptability of a Religiously-Tailored Text Messaging Intervention to Reduce Smoking Among Somali Muslim Men During Ramadan. Nicotine Tob Res. 2021 Aug 4;23(8):1283-1290. doi: 10.1093/ntr/ntaa260.

  PMID: 33277991 DERIVED

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Olamide Ojo-Fati, MD MPH

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 20, 2017
• Study Start: December 30, 2017
• Primary Completion: September 21, 2018
• Study Completion: December 21, 2019
• Last Updated: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)