Hookah Tobacco SmokingNCT04252014
Optimizing Hookah Tobacco Public Education Messages to Reduce Young Adult Use
A study testing Hookah tobacco messages in people with Hookah Tobacco Smoking, run by Georgetown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Hookah Tobacco Smoking
- What is being tested?
- Hookah tobacco messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 830 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2020to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
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.
Read the 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
- Being tested
- Hookah tobacco messages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hookah tobacco messagesBehavioural
Messages communicating the risks of hookah tobacco use in 4 thematic areas: health harms, addictiveness, social use, flavorings.
| Study group | Role | What they receive |
|---|---|---|
| Non-Tobacco Messages | No intervention | 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. |
| Hookah Tobacco Messages | Experimental | 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. Receives: Behavioral: Hookah tobacco messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hookah Tobacco Initiation
Hookah tobacco initiation among those who are susceptible non-users at baseline will be measured using a single valid survey question asking if participants have ever used hookah tobacco, even one or two puffs, at follow-up. The question asks if participants have ever smoked hookah tobacco based on a yes/no response. No hookah tobacco initiation is considered a better outcome. The outcome measure data reports those who responded "Yes" and are considered to have initiated hookah tobacco at the 6 month follow-up.
Measured: 6 months
Hookah Tobacco Use Frequency
Hookah tobacco use frequency will be measured in baseline current hookah users with a single valid question asking on how many days they smoked hookah tobacco in the past 30 days. Baseline current hookah users who reported they quit were coded as smoking 0 of the past 30 days. Less frequent hookah use is considered a better outcome.
Measured: 6 months
Hookah Tobacco Cessation
Hookah tobacco cessation is measured using a single valid question adapted from the national Population Assessment of Tobacco and Health (PATH) survey asking participants who report they have not smoked hookah tobacco if they have stopped smoking hookah tobacco completely. The item asks if participants have completely stopped smoking hookah tobacco based on a yes/no response. Quitting hookah tobacco use (i.e., a response of "yes") is considered a better outcome. The outcome measure data reports those who responded "Yes" and are considered to have stopped smoking hookah tobacco completely at the 6 month follow-up.
Measured: 6 months
Secondary outcomes (2)
Hookah Tobacco Curiosity
Curiosity to use hookah tobacco will be measured with a single valid item with a 7-point response ranging from 1 (not at all curious) to 7 (very curious) among those who are baseline susceptible non-users. This item will be administered at all time points. Outcomes from the 6-month follow-up are reported. A lower value on the response is considered a better outcome (i.e., less curious in using hookah tobacco).
Measured: 6 months
Motivation to Quit Smoking Hookah Tobacco
Motivation to quit smoking hookah tobacco will be measured with a single valid item with a 7-point response ranging from 1 (not at all motivated) to 7 (very motivated) among those who are current hookah users. This item will be administered at all time points. A higher value on the response is considered a better outcome (i.e., more motivated to quit smoking hookah tobacco). Outcomes at the 6-month follow-up are reported.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start4 Feb 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hookah Tobacco SmokingStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 830 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Darren Mays, PhD, MPH, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252014
- Sponsor's protocol ID
- STUDY00000277
- Other IDs
- R01CA229082
- Status last verified
- Jul 2022
- First submitted
- 30 Jan 2020
- Last updated
- 13 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie study results will be made available upon request by researchers after completion of the study and publication of primary findings.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Hookah Tobacco Public Education Messages to Reduce Young Adult Use
- ClinicalTrials.gov ID
- NCT04252014
- Acronym / sponsor ID
- STUDY00000277
- Conditions
- Hookah Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 830 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Posted 13 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Non-Tobacco Messages | No intervention | –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. |
| Hookah Tobacco Messages | Experimental | Behavioral: Hookah tobacco messagesParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hookah tobacco messagesMessages communicating the risks of hookah tobacco use in 4 thematic areas: health harms, addictiveness, social use, flavorings. | Behavioural | Hookah Tobacco Messages |
Primary outcome
Hookah Tobacco Initiation
Time frame: 6 months
Hookah tobacco initiation among those who are susceptible non-users at baseline will be measured using a single valid survey question asking if participants have ever used hookah tobacco, even one or two puffs, at follow-up. The question asks if participants have ever smoked hookah tobacco based on a yes/no response. No hookah tobacco initiation is considered a better outcome. The outcome measure data reports those who responded "Yes" and are considered to have initiated hookah tobacco at the 6 month follow-up.
Hookah Tobacco Use Frequency
Time frame: 6 months
Hookah tobacco use frequency will be measured in baseline current hookah users with a single valid question asking on how many days they smoked hookah tobacco in the past 30 days. Baseline current hookah users who reported they quit were coded as smoking 0 of the past 30 days. Less frequent hookah use is considered a better outcome.
Hookah Tobacco Cessation
Time frame: 6 months
Hookah tobacco cessation is measured using a single valid question adapted from the national Population Assessment of Tobacco and Health (PATH) survey asking participants who report they have not smoked hookah tobacco if they have stopped smoking hookah tobacco completely. The item asks if participants have completely stopped smoking hookah tobacco based on a yes/no response. Quitting hookah tobacco use (i.e., a response of "yes") is considered a better outcome. The outcome measure data reports those who responded "Yes" and are considered to have stopped smoking hookah tobacco completely at the 6 month follow-up.
2 secondary outcomes
Hookah Tobacco Curiosity
Time frame: 6 months
Motivation to Quit Smoking Hookah Tobacco
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie study results will be made available upon request by researchers after completion of the study and publication of primary findings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Mays, PhD, MPH principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hookah tobacco messages in people with Hookah Tobacco Smoking, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hookah Tobacco Initiation (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.