Optimizing Hookah Tobacco Public Education Messages to Reduce Young Adult Use

NCT ID: NCT04252014

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 830 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-04
• Study Completion Date: 2022-04-30

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.

Conditions

Hookah Tobacco Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Non-Tobacco Messages

Participants in the control group will receive messages about health topics unrelated to tobacco use (e.g., sun safety). Messages will be delivered online through 4 brief study communications.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Hookah Tobacco Messages

Participants in the hookah tobacco messaging group will receive 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.

Group Type: EXPERIMENTAL

Hookah tobacco messages

Intervention Type: BEHAVIORAL

Messages communicating the risks of hookah tobacco use in 4 thematic areas: health harms, addictiveness, social use, flavorings.

Interventions

Hookah tobacco messages

Messages communicating the risks of hookah tobacco use in 4 thematic areas: health harms, addictiveness, social use, flavorings.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Darren Mays, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

Georgetown University

Washington D.C., District of Columbia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01CA229082

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00000277

Identifier Type: -

Identifier Source: org_study_id