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

Not Applicable

Not yet recruiting

• Conditions: Shisha
• Interventions: Radiation: CHW-delivered intervention

• Registration Number: NCT06316947
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-17
• Study First Posted: 2024-03-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-15
• Study Start: 2025-06-15
• Primary Completion: 2025-12-15
• Study Completion: 2026-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Families	CHW-delivered intervention	Somali American families with children in the household and at least one adult using shisha at home

Primary Outcome Measures

Name	Time	Method
pre-/post- survey completion rates	8 weeks	proportion of participants who complete the pre and post-intervention surveys
pre-/post- biospecimen completion rates	8 weeks	proportion of participants who complete the urine sample collection
Recruitment rate	8 weeks	number of recruited participants out of number of approached
Retention rate measure	8 weeks	proportion of participants who complete the 2 visits for data collection

Secondary Outcome Measures

Name	Time	Method
the cotinine levels of parents and children.	8 weeks	Pre-/post- changes in the cotinine levels of parents and children.
shisha use changes	8 weeks	Pre-/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 changes	8 weeks	Pre-/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 rules	8 weeks	Pre-/post- changes in the presence of smoke-free home rules. A pre-pilot survey has been developed and will assess this outcome measure.