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

NCT ID: NCT06316947

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-03
• Study Completion Date: 2026-03-01

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.

Conditions

Shisha

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Families

Somali American families with children in the household and at least one adult using shisha at home

Group Type: EXPERIMENTAL

CHW-delivered intervention

Intervention Type: RADIATION

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.

Interventions

CHW-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.

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

April Wilhelm, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

FMCH-2024-32723

Identifier Type: -

Identifier Source: org_study_id