ShishaNCT06316947
Developing and Pilot Testing an Intervention to Reduce Household Shisha Smoke Exposure Within Somali Homes
A study testing CHW-delivered intervention in people with Shisha, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Shisha
- What is being tested?
- CHW-delivered intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2025to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participation in previous qualitative study to inform intervention development
- Inability or unwillingness to provide informed consent and complete all study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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
- Being tested
- CHW-delivered intervention
- Medical subject headings
- Water Pipe Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHW-delivered interventionRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Families | Experimental | Somali American families with children in the household and at least one adult using shisha at home Receives: Radiation: CHW-delivered intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
number of recruited participants out of number of approached
Measured: 8 weeks
Retention rate measure
proportion of participants who complete the 2 visits for data collection
Measured: 8 weeks
pre-/post- survey completion rates
proportion of participants who complete the pre and post-intervention surveys
Measured: 8 weeks
pre-/post- biospecimen completion rates
proportion of participants who complete the urine sample collection
Measured: 8 weeks
Secondary outcomes (4)
shisha use changes
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.
Measured: 8 weeks
tobacco product use changes
Pre-/post- changes in the frequency of other tobacco product use. A pre-pilot survey has been developed and will assess this outcome measure.
Measured: 8 weeks
smoke-free home rules
Pre-/post- changes in the presence of smoke-free home rules. A pre-pilot survey has been developed and will assess this outcome measure.
Measured: 8 weeks
the cotinine levels of parents and children.
Pre-/post- changes in the cotinine levels of parents and children.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start3 Sep 2025
- Primary completion15 Mar 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShishaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a feasibility pilot of the new CHW-delivered intervention to reduce home shisha SHS exposure with n=15 Somali families.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- April Wilhelm, MD, MPH, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316947
- Sponsor's protocol ID
- FMCH-2024-32723
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Pilot Testing an Intervention to Reduce Household Shisha Smoke Exposure Within Somali Homes
- ClinicalTrials.gov ID
- NCT06316947
- Acronym / sponsor ID
- FMCH-2024-32723
- Conditions
- Shisha
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a feasibility pilot of the new CHW-delivered intervention to reduce home shisha SHS exposure with n=15 Somali families.
| Arm | Type | Receives |
|---|---|---|
| Families | Experimental | Radiation: CHW-delivered interventionSomali American families with children in the household and at least one adult using shisha at home |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Participation in previous qualitative study to inform intervention development
- Inability or unwillingness to provide informed consent and complete all study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHW-delivered interventionWellShare 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. | Radiation | Families |
Primary outcome
Recruitment rate
Time frame: 8 weeks
number of recruited participants out of number of approached
Retention rate measure
Time frame: 8 weeks
proportion of participants who complete the 2 visits for data collection
pre-/post- survey completion rates
Time frame: 8 weeks
proportion of participants who complete the pre and post-intervention surveys
pre-/post- biospecimen completion rates
Time frame: 8 weeks
proportion of participants who complete the urine sample collection
4 secondary outcomes
shisha use changes
Time frame: 8 weeks
tobacco product use changes
Time frame: 8 weeks
smoke-free home rules
Time frame: 8 weeks
the cotinine levels of parents and children.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
Related trials for Shisha
Recruiting
Feasibility and Uptake of Low-Dose CT Lung Cancer Screening in Kuwait
Lung Cancer, Lung Neoplasms
Active, not recruiting
Secondhand Effects of Hookah (i.e., Waterpipe) Smoke and Aerosol
Hookah Smoking, Secondhand Aerosol
Not yet recruiting
Evaluating the Efficacy of a Text Messaging-based Shisha Smoking Cessation Intervention
Intervention, Control
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
April Wilhelm, MD, MPH principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHW-delivered intervention in people with Shisha, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.