Clinical trial NCT03595280: Optimizing Risk Messages for Waterpipe Tobacco Cessation in Young Adults
Official title: Optimizing Risk Messages for Waterpipe Tobacco Cessation in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hookah Smoking
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-07-23
Enrollment: 349
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized trial with 3 groups: 1) Control group that receives no study messages; 2) Untailored message group that receives general messages about the risks of hookah tobacco; 3) Tailored message group that receives messages about the risks of hookah tobacco that are personalized to their hookah tobacco use behavior and beliefs.
Primary purpose: PREVENTION

Brief summary: The objective of this study is to examine whether messages conveying the harms and addictiveness of waterpipe (i.e., hookah) tobacco delivered by mobile phone multimedia messaging (MMS) are effective for promoting hookah tobacco cessation among young adults ages 18 to 30 years.

Detailed description: The purpose of this study is to test the effects of messages communicating the risks (i.e., health harms, addictiveness) of hookah tobacco delivered via mobile multimedia messaging for promoting hookah tobacco cessation. The study will also compare two messaging approaches, a standard untailored approach where all participants receive the same message content, and a tailored messaging approach where message content is personalized to baseline measures of hookah tobacco use behavior and beliefs and interactively to exchanges that occur via mobile messaging sent and received during the exposure period. The study includes young adults ages 18 to 30 who are current hookah tobacco smokers. Eligible participants are young adults ages 18 to 30 years who have smoked hookah tobacco at least once in the past month, smoke hookah tobacco on at least a monthly basis, and have access to the internet and a personal mobile phone to complete study procedures. Study participants will complete a baseline survey online, and all participants will receive standard information about the risks of hookah tobacco. Then participants will be randomly assigned to one of three groups: control group, untailored message group, tailored message group. Participants in the untailored and tailored message group will receive messages sent to their mobile phones communicating the risks of hookah tobacco for a 6 week period. All participants will complete follow-up surveys online 6 weeks after baseline, 3 months later, and 6 months later.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 30
* Smoked hookah tobacco within the last 30 days and smokes hookah tobacco on at least a monthly basis
* Has access the internet to complete study procedures
* Has personal mobile phone to complete study procedures

Exclusion Criteria:

* Age less than 18 or greater than 30
* Has not smoked hookah tobacco in the last 30 days or does not smoke hookah tobacco on at least a monthly basis
* Does not have access to the internet to complete study procedures
* Does not have a personal mobile phone to complete study procedures

Primary 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
measure: Motivation to Quit
timeFrame: 6-months
measure: Hookah Tobacco Use Frequency
timeFrame: 6 months
measure: Percent of Participants Who Quit Smoking Hookah Tobacco
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Georgetown University
name: Darren Mays, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: