Optimizing Risk Messages for Waterpipe Tobacco Cessation in Young Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimizing Risk Messages for Waterpipe Tobacco Cessation in Young Adults

Conditions
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Hookah Smoking

Intervention / Treatment
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* Behavioral: Hookah tobacco risk messages


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants in the control group receive no study messages | |
| Experimental: Untailored Messages<br>Participants in the untailored message group receive mobile multimedia service messages conveying the risks of hookah tobacco on their mobile phones. | Behavioral: Hookah tobacco risk messages<br>* Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use.<br>|
| Experimental: Tailored Messages<br>Participants in the tailored message group receive mobile multimedia service messages conveying the risks of hookah tobacco on their mobile phones that are personalized to their hookah tobacco use behavior and beliefs. | Behavioral: Hookah tobacco risk messages<br>* Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Harm | Perceived harm of hookah tobacco is measured using valid self-report item assessing perceptions of how likely harms are to occur from hookah tobacco use (response range 1 no chance to 7 certain to happen). Greater perceived likelihood of harm is considered a better outcome. The assessment is administered immediately post intervention, 3-month follow-up, and 6-month follow-up, 6 month follow-up data reported. | 6-months | 
| Perceived Addictiveness | Perceived addictiveness of hookah tobacco is measured using valid self-report item assessing perceptions of how likely one is to become addicted to hookah tobacco (1 = no chance, 7 = certain to happen). Greater perceived likelihood of addictiveness is considered a better outcome. The assessment is administered immediately post-intervention, 3-month follow-up, and 6 month follow-up, 6-month follow-up data reported. | 6-months | 
| Worry About Harm | Worry about the harms of hookah tobacco is measured using a valid self-report item assessing how much participants worry about the risks of hookah tobacco (1 = Not at all, 7 = Very much). Greater worry about harm is considered a better outcome. The assessment is administered immediately post-intervention, 3-month follow-up, and 6 month follow-up, 6-month follow-up reported. | 6-months | 
| Worry About Addictiveness | Worry about the addictiveness of hookah tobacco is measured using a valid self-report item assessing how much participants worry about becoming addicted to hookah tobacco (1 = Not at all, 7 = very much). Greater perceived addictiveness is considered a better outcome. The assessment is administered immediately post-intervention, 3 month follow-up, and 6 month-follow-up, 6 month follow-up reported. | 6 months | 
| Motivation to Quit | Motivation to quit is measured using a valid self-report item assessing how much participants want to quit smoking hookah tobacco right now (1 = Not at all, 7 = Very). Greater motivation to quit is considered a better outcome. The assessment is administered immediately post-intervention, 3 month follow-up, and 6 month follow-up, 6-month follow-up reported. | 6-months | 
| Hookah Tobacco Use Frequency | Hookah tobacco use frequency is measured using a valid self-report item assessing how often participants have smoked hookah tobacco in the past 30 days. The item measures the number of days in the past month participants have smoked hookah tobacco. Less frequent hookah tobacco use is considered a better outcome. The assessment is administered immediately post-intervention, 3 month follow-up, and 6 month follow-up, 6-month follow-up reported. | 6 months | 
| Percent of Participants Who Quit Smoking Hookah Tobacco | Hookah tobacco cessation is measured using a single valid self-report item assessing if participants 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., responses of yes) is considered a better outcome. The assessment is administered immediately post intervention, 3 month follow-up, and 6 month follow-up, 6-month follow-up data reported. | 6 months |