A Study of Hookah Café Customers in the Atlanta Area

Not Applicable

Completed

• Conditions: Waterpipe Tobacco Smoking
• Interventions: Behavioral: No Warnings; Behavioral: Health Warnings

• Registration Number: NCT05916170
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-05-10
• Study Start: 2023-06-01
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-23
• Status Verified: 2024-03
• Primary Completion: 2024-11-21
• Study Completion: 2024-11-21
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 977

Inclusion Criteria

• Planning to enter the hookah café where study is being conducted
• Age 18 or older
• English speaking
• Planning to smoke hookah inside
• Not planning to smoke cigarettes, cigars, cigarillos or marijuana while at the hookah café
• Had not previously entered the café earlier in the day 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
• Are not employees of the business
• Have capacity to participate as determined by the staff member conducting eligibility screening

Exclusion Criteria

• Not planning to enter the hookah café where the study is being conducted
• Age 17 and under
• Non-English speaking
• Not planning to smoke hookah in the café
• Planning to smoke cigarettes, cigars, or marijuana while at the hookah café
• Are employees of the business
• Had previously entered the café on the same day/night as data collection
• Has not been approached to participate in the study previously
• Does not have capacity to participate as determined by the staff member conducting eligibility screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control - No Warnings	No Warnings	No warnings posted in the hookah café
Intervention - Health Warnings	Health Warnings	Cafes will display text-only warning signs

Primary Outcome Measures

Name	Time	Method
Changes in Expired Carbon Monoxide (eCO Boost)	Baseline and after exiting the café up to 10 hours	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.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States