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Completed

NCT Number: NCT06316947

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

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.

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Key information

Conditions

Shisha Behavior Pipe Smoking Smoking Water Pipe Smoking

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHW-delivered intervention

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.

Primary outcomes

  1. Recruitment rate

    Time frame: 8 weeks

    number of recruited participants out of number of approached

  2. Retention rate measure

    Time frame: 8 weeks

    proportion of participants who complete the 2 visits for data collection

  3. pre-/post- survey completion rates

    Time frame: 8 weeks

    proportion of participants who complete the pre and post-intervention surveys

  4. pre-/post- biospecimen completion rates

    Time frame: 8 weeks

    proportion of participants who complete the urine sample collection

Secondary outcomes

  1. shisha use changes

    Time frame: 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.

  2. tobacco product use changes

    Time frame: 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.

  3. smoke-free home rules

    Time frame: 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.

  4. the cotinine levels of parents and children.

    Time frame: 8 weeks

    Pre-/post- changes in the cotinine levels of parents and children.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2024
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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