Clinical trial NCT04252014: Optimizing Hookah Tobacco Public Education Messages to Reduce Young Adult Use
Official title: Optimizing Hookah Tobacco Public Education Messages to Reduce Young Adult Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hookah Tobacco Smoking
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-02-05
Enrollment: 830
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention consists of brief hookah tobacco public education messages delivered online through 4 brief study communications. Messages will communicate about the risks of hookah tobacco use in the following theme areas: 1) Health Harms; 2) Addictiveness; 3) Social Use; 4) Flavorings. The order of message themes delivered in each study communication will be randomized.
Primary purpose: PREVENTION

Brief summary: This is a 2-arm randomized controlled trial to test the effects of hookah tobacco public education messages among young adults who are susceptible non-users of hookah tobacco and those who are current hookah tobacco users. The primary outcomes are hookah tobacco use behavior (initiation among baseline susceptible non-users, frequency of use and cessation among baseline current users) at 6-month follow-up. Secondary outcomes are curiosity to use hookah tobacco (susceptible non-users) and motivation to quit using hookah tobacco (current hookah users) measured at 6-month follow-up. These outcomes will also be measured at 2- and 4-month follow-up time points.

Detailed description: This is a 2-arm randomized controlled trial to test the effects of hookah tobacco public education messages among young adults who are susceptible non-users of hookah tobacco and current hookah tobacco users. Primary outcomes of hookah use behavior will be measured at the 6-month follow-up assessment. Secondary outcomes include curiosity to use hookah tobacco among susceptible non-users and motivation to quit using hookah tobacco among current users. All outcomes are also assessed at 2- and 4-month follow-up time points. All trial participants will be recruited from a US national consumer research panel. Eligible participants will be 1) young adults ages 18 to 30 (inclusive); 2) who have never used hookah tobacco but are deemed susceptible or report hookah tobacco use at least once within the past month; and 3) are enrolled members of the partnering consumer research panel. Panel members will be contacted via email with a brief description of the study and a link to an eligibility screener and online informed consent form. Eligible participants will complete a secure online baseline assessment of demographic characteristics, tobacco use history, and measures of hookah tobacco use behavior, beliefs, attitudes, and perceptions. After completing a baseline, participants will be randomly assigned in approximately equal numbers to one of two arms: 1) hookah tobacco messaging arm; 2) control arm. Through 4 brief study communications delivered approximately weekly, participants will receive study messages to which they are randomized and will complete brief self-report measures online on their responses to the messages. For the hookah tobacco messaging arm, communications will consist of study messages conveying risks of hookah tobacco use with random assignment of the order of messages with each exposure. In response to each message, participants will complete measures of message response and hookah-related beliefs, attitudes, and perceptions. Participants in the control condition will receive study communications with brief messages about health behaviors unrelated to tobacco (e.g., sun protection) and will complete the same measures. Hookah tobacco use behaviors, intentions and curiosity to use hookah tobacco (non-users), motivation to quit (current users), and hypothesized mediators will be assessed 2-, 4-, and 6-months after the message exposure period with the primary outcomes captured at 6-month follow-up.

Eligibility criteria: Inclusion Criteria:

* Age between 18 to 30
* Smoked hookah tobacco within the past 30 days, OR never smoked hookah tobacco and deemed susceptible to using hookah tobacco based on answers to screening questions
* Member of partnering consumer research panel conducting the study

Exclusion Criteria:

* Age less than 18 or greater than 30
* Has not smoked hookah tobacco in the past 30 days OR has never smoked hookah tobacco and is not susceptible
* Not a member of partnering consumer research panel conducting the study

Primary outcomes:
measure: Hookah Tobacco Initiation
timeFrame: 6 months
measure: Hookah Tobacco Use Frequency
timeFrame: 6 months
measure: Hookah Tobacco Cessation
timeFrame: 6 months
Secondary outcomes:
measure: Hookah Tobacco Curiosity
timeFrame: 6 months
measure: Motivation to Quit Smoking Hookah Tobacco
timeFrame: 6 months
Other outcomes:
measure: Perceived Harm
timeFrame: 6 months
measure: Perceived Addictiveness
timeFrame: 6 months
measure: Worry About Harm
timeFrame: 6 months
measure: Worry About Addictiveness
timeFrame: 6 months
Locations:
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Darren Mays, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: