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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA217861 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Participants in the control group receive no study messages | |
| Untailored Messages | Experimental | Participants in the untailored message group receive mobile multimedia service messages conveying the risks of hookah tobacco on their mobile phones. |
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| Tailored Messages | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hookah tobacco risk messages | Behavioral | Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darren Mays, PhD, MPH | Georgetown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States | ||
| Duke University |
We will consider requests to share de-identified individual participant data by request and according to the investigator's study protocol and institutional data sharing policy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Participants in the control group receive no study messages |
| FG001 | Untailored Messages | Participants in the untailored message group receive mobile multimedia service messages conveying the risks of hookah tobacco on their mobile phones. Hookah tobacco risk messages: Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use. |
| FG002 | Tailored Messages | 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. Hookah tobacco risk messages: Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Participants in the control group receive no study messages |
| BG001 | Untailored Messages | Participants in the untailored message group receive mobile multimedia service messages conveying the risks of hookah tobacco on their mobile phones. Hookah tobacco risk messages: Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 6-months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Participants in the control group receive no study messages | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Darren Mays | Georgetown University | 2026878937 | dmm239@georgetown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 28, 2017 | Oct 6, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 28, 2017 | Oct 6, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000073867 | Water Pipe Smoking |
| ID | Term |
|---|---|
| D000073868 | Pipe Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
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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.
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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 |
| Durham |
| North Carolina |
| 27708 |
| United States |
| BG002 | Tailored Messages | 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. Hookah tobacco risk messages: Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| OG002 | Tailored Messages | 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. Hookah tobacco risk messages: Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use. |
|
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| Primary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 6-months |
|
|
|
| Primary | 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. | Posted | Median | 95% Confidence Interval | score on a scale | 6-months |
|
|
|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 6 months |
|
|
|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6-months |
|
|
|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | days in the past month | 6 months |
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|
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| Primary | 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. | Posted | Number | percentage of participants | 6 months |
|
|
|
| 113 |
| 0 |
| 113 |
| 0 |
| 113 |
| EG001 | Untailored Messages | Participants in the untailored message group receive mobile multimedia service messages conveying the risks of hookah tobacco on their mobile phones. Hookah tobacco risk messages: Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use. | 0 | 108 | 0 | 108 | 0 | 108 |
| EG002 | Tailored Messages | 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. Hookah tobacco risk messages: Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use. | 0 | 98 | 0 | 98 | 0 | 98 |
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