Clinical trial NCT05916170: A Study of Hookah Café Customers in the Atlanta Area
Official title: Communicating Waterpipe Tobacco Harms to Reduce Use Among Young Adults: A Study of Hookah Café Customers in the Atlanta Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Waterpipe Tobacco Smoking
Keywords: Waterpipe Tobacco Smoking
Tobacco Smoking
waterpipe smoking behavior
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-06-23
Enrollment: 977
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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, where they will display one of four text-only warning signs. Participants will only participate in one of the arms.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Expired Carbon Monoxide (eCO Boost)
timeFrame: Baseline and after exiting the café up to 10 hours
Secondary outcomes:
Other outcomes:
measure: Behavioral intention
timeFrame: at exit; up to 10 hours
measure: Quit motivation
timeFrame: at exit; up to 10 hours
measure: Hookah use behavior
timeFrame: at exit; up to 10 hours
measure: Subjective experiences of smoking hookah
timeFrame: at exit; up to 10 hours
measure: Knowledge
timeFrame: at exit; up to 10 hours
measure: Beliefs
timeFrame: at exit; up to 10 hours
measure: Warning recall
timeFrame: at exit; up to 10 hours
measure: Warning recognition
timeFrame: at exit; up to 10 hours
measure: Social interaction
timeFrame: at exit; up to 10 hours
measure: Perceived influence of warning on smoking behavior answers
timeFrame: at exit; up to 10 hours
measure: Time spent in the café
timeFrame: at exit; up to 10 hours
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Erin Sutfin, PhD
role: PRINCIPAL_INVESTIGATOR
References: