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Developing and Pilot Testing an Intervention to Reduce Household Shisha Smoke Exposure Within Somali Homes

Developing and Pilot Testing an Intervention to Reduce Household Shisha Smoke Exposure Within Somali Homes

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06316947
Enrollment
15
Registered
2024-03-19
Start date
2025-09-03
Completion date
2026-03-15
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shisha

Brief summary

Previous qualitative research among Somali American adults in Minnesota have identified high levels of hookah or shisha (hereafter shisha) use in Somali households. Household shisha use exposes all family members, including children, to secondhand smoke (SHS) that contains toxins that can cause many different acute and chronic disease, including increased levels of several cancers such as lung, bladder, and oral cancers. Despite the high levels of shisha use, gaps in the knowledge of the risks of shisha use and how to mitigate the potential harmful health consequences of shisha use exist among Somali Americans. This study aims to pilot test the feasibility of a newly developed CHW-delivered intervention to reduce home shisha SHS exposure with n=15 Somali families. Pre-/post-measurements of family members' (1 adult and 1 child) urine or salivary cotinine levels will be obtained along with a brief pre-/post-survey to characterize household tobacco use and the presence of home smoke-free rules.

Interventions

RADIATIONCHW-delivered intervention

WellShare CHWs will then deliver the brief, approximately 15-minute intervention to the participating parent. The new intervention components will build off existing tobacco education outreach using verbal instruction and images developed by WellShare CHWs and layer in home smoke-free rules, potential biomarker feedback about smoke exposure, and other educational intervention components that align. Additionally there will be pre and post-intervention surveys and urine samples collection for cotinine levels.

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

a feasibility pilot of the new CHW-delivered intervention to reduce home shisha SHS exposure with n=15 Somali families.

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes

Inclusion criteria

Eligible families will identify as * Somali American, * have one or more children between 6 months and 18 years of age in the home, and * have at least one adult who uses shisha at home. Families with other forms of tobacco use in addition to shisha use will be included.

Exclusion criteria

* Participation in previous qualitative study to inform intervention development * Inability or unwillingness to provide informed consent and complete all study procedures

Design outcomes

Primary

MeasureTime frameDescription
Recruitment rate8 weeksnumber of recruited participants out of number of approached
Retention rate measure8 weeksproportion of participants who complete the 2 visits for data collection
pre-/post- survey completion rates8 weeksproportion of participants who complete the pre and post-intervention surveys
pre-/post- biospecimen completion rates8 weeksproportion of participants who complete the urine sample collection

Secondary

MeasureTime frameDescription
shisha use changes8 weeksPre-/post- changes (baseline to 8 week follow-up) in the frequency of shisha use. A pre-pilot survey has been developed and will assess this outcome measure.
tobacco product use changes8 weeksPre-/post- changes in the frequency of other tobacco product use. A pre-pilot survey has been developed and will assess this outcome measure.
smoke-free home rules8 weeksPre-/post- changes in the presence of smoke-free home rules. A pre-pilot survey has been developed and will assess this outcome measure.
the cotinine levels of parents and children.8 weeksPre-/post- changes in the cotinine levels of parents and children.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORApril Wilhelm, MD, MPH

University of Minnesota

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026