- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03379142
Faith Based Pilot Intervention to Reduce Tobacco Use Among Somali Males
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55412
- University of Minnesota
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Minneapolis, Minnesota, Forente stater, 55414
- WellShare International
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: Behavioral: Faith-Based messages
We will send faith-based messages one week prior to Ramadan and twice a day during Ramadan.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Participants Adherence to the Intervention
Tidsramme: 8 weeks
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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.
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8 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
smoking cessation
Tidsramme: 8 weeks
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CO breath test at week 4 and week 8
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8 weeks
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Olamide Ojo-Fati, MD MPH, University of Minnesota
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- FMCH-2017-25736
Plan for individuelle deltakerdata (IPD)
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