Waterpipe Warnings Aim 3 Hookah Café Study

Study Overview
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Brief Summary
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The purpose of the study is to assess the effectiveness of health warnings on waterpipe smoking behavior in a real-world setting. The primary hypothesis is that hookah café customers who are in the intervention (warning) arm will smoke less than customers who are in the control (no warning) arm, determined by differences in the boost in expired carbon monoxide from café entry to after café exit.

Detailed Description
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Expired carbon monoxide is an objective biological marker of combustible tobacco smoking and is strongly correlated with the amount of smoke inhaled. In the intervention arm, warning messages will be displayed at various agreed-upon locations in the café, such as on hookah pipes, tables, countertops, walls, and menus. The goal is to maximize the potential for customers to be exposed to warnings. Participants will be patrons of the café and will be recruited before entering the café. Participants will complete a brief survey and provide a breath sample to measure expired carbon monoxide. When leaving the café, they will complete another survey and provide a second breath sample.

Official Title
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Communicating Waterpipe Tobacco Harms to Reduce Use Among Young Adults: A Study of Hookah Café Customers in the Atlanta Area

Conditions
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Waterpipe Tobacco Smoking

Intervention / Treatment
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* Behavioral: Health Warnings
* Behavioral: No Warnings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking Planning to smoke hookah inside Not planning to smoke cigarettes, cigars, or other forms of combustible tobacco or marijuana while at the hookah café Have not previously entered the café on the same day/night as data collection Has not been approached to participate in the study at another café or another day/night at the current café Is not an employee of the café Demonstrated adequate capacity to consent to participate based on ability to understand and answer screening questions Exclusion Criteria: Younger than 18 or older than 35 Not planning to enter the hookah café where the study is being conducted Non-English speaking Not planning to smoke hookah in the café Planning to smoke cigarettes, cigars, or marijuana while at the hookah café Have previously entered the café on the same day/night as data collection Has been approached to participate in the study previously Is an employee of the café Did not demonstrate adequate capacity to consent to participate, based on ability to understand and answer screening questions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The design of the study is a cluster randomized crossover trial, where the hookah café is the cluster and randomization is at the cluster level. Each hookah café will serve as its own control and will be used for data collection for both arms of the study. Cafes will start in the no-warning control arm and then will cross over to the intervention arm. Half of the cafés in the intervention arm will be randomly assigned to display a text-only warning and the other half with display a pictorial warning (text + image). Participants will only participate in one of the arms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention - Health Warnings<br>Half of the cafés in the intervention arm will be randomly assigned to display a text-only warning and the other half with display a pictorial warning (text + image). | Behavioral: Health Warnings<br>* Text-only or pictorial warnings about one health harm will be displayed in the hookah cafés where data collection is being conducted.<br>|
| Experimental: Control - No Warnings<br>No warnings posted in the hookah café | Behavioral: No Warnings<br>* No warnings posted in the hookah café<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Expired Carbon Monoxide (eCO Boost) | Change in eCO from baseline (before entry into the hookah café) to follow-up (upon exit from the hookah café) - eCO will be measured with the Bedfont Micro+ Smokerlyzer. Higher scores represent higher concentrations of Carbon Monoxide (CO), which is correlated with greater waterpipe use. | Baseline and after exiting the café up to 10 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Waterpipe Tobacco Smoking, Tobacco Smoking, waterpipe smoking behavior