Trial Outcomes & Findings for Optimizing Risk Messages for Waterpipe Tobacco Cessation in Young Adults (NCT NCT03595280)
NCT ID: NCT03595280
Last Updated: 2021-10-20
Results Overview
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.
COMPLETED
NA
349 participants
6-months
2021-10-20
Participant Flow
Participant milestones
| Measure |
Control
Participants in the control group receive no study messages
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
119
|
117
|
113
|
|
Overall Study
COMPLETED
|
113
|
108
|
98
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
15
|
Reasons for withdrawal
| Measure |
Control
Participants in the control group receive no study messages
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
9
|
15
|
Baseline Characteristics
Optimizing Risk Messages for Waterpipe Tobacco Cessation in Young Adults
Baseline characteristics by cohort
| Measure |
Control
n=119 Participants
Participants in the control group receive no study messages
|
Untailored Messages
n=117 Participants
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.
|
Tailored Messages
n=113 Participants
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.
|
Total
n=349 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
23.9 years
STANDARD_DEVIATION 3.4 • n=93 Participants
|
23.7 years
STANDARD_DEVIATION 3.5 • n=4 Participants
|
24.6 years
STANDARD_DEVIATION 3.5 • n=27 Participants
|
24.0 years
STANDARD_DEVIATION 3.4 • n=483 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
187 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=93 Participants
|
60 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
162 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=93 Participants
|
103 Participants
n=4 Participants
|
101 Participants
n=27 Participants
|
308 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
31 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
80 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
147 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
30 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
82 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Education
Less Than College Education
|
16 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
56 Participants
n=483 Participants
|
|
Education
Some College or Higher
|
103 Participants
n=93 Participants
|
93 Participants
n=4 Participants
|
97 Participants
n=27 Participants
|
293 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 6-monthsPerceived 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.
Outcome measures
| Measure |
Control
n=113 Participants
Participants in the control group receive no study messages
|
Untailored Messages
n=108 Participants
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.
|
Tailored Messages
n=98 Participants
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.
|
|---|---|---|---|
|
Perceived Harm
|
4.1 score on a scale
Interval 3.9 to 4.4
|
4.2 score on a scale
Interval 4.0 to 4.5
|
4.5 score on a scale
Interval 4.2 to 4.8
|
PRIMARY outcome
Timeframe: 6-monthsPerceived 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.
Outcome measures
| Measure |
Control
n=113 Participants
Participants in the control group receive no study messages
|
Untailored Messages
n=108 Participants
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.
|
Tailored Messages
n=98 Participants
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.
|
|---|---|---|---|
|
Perceived Addictiveness
|
3.9 score on a scale
Interval 3.5 to 4.2
|
3.9 score on a scale
Interval 3.6 to 4.3
|
4.0 score on a scale
Interval 3.7 to 4.3
|
PRIMARY outcome
Timeframe: 6-monthsWorry 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.
Outcome measures
| Measure |
Control
n=113 Participants
Participants in the control group receive no study messages
|
Untailored Messages
n=108 Participants
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.
|
Tailored Messages
n=98 Participants
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.
|
|---|---|---|---|
|
Worry About Harm
|
4.6 score on a scale
Interval 4.3 to 5.0
|
4.1 score on a scale
Interval 3.8 to 4.5
|
4.6 score on a scale
Interval 4.3 to 5.0
|
PRIMARY outcome
Timeframe: 6 monthsWorry 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.
Outcome measures
| Measure |
Control
n=113 Participants
Participants in the control group receive no study messages
|
Untailored Messages
n=108 Participants
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.
|
Tailored Messages
n=98 Participants
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.
|
|---|---|---|---|
|
Worry About Addictiveness
|
3.6 score on a scale
Interval 3.2 to 3.9
|
3.7 score on a scale
Interval 3.3 to 4.1
|
3.9 score on a scale
Interval 3.5 to 4.3
|
PRIMARY outcome
Timeframe: 6-monthsMotivation 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.
Outcome measures
| Measure |
Control
n=113 Participants
Participants in the control group receive no study messages
|
Untailored Messages
n=108 Participants
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.
|
Tailored Messages
n=98 Participants
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.
|
|---|---|---|---|
|
Motivation to Quit
|
4.0 units on a scale
Interval 3.5 to 4.4
|
4.0 units on a scale
Interval 3.5 to 4.4
|
3.5 units on a scale
Interval 3.0 to 4.1
|
PRIMARY outcome
Timeframe: 6 monthsHookah 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.
Outcome measures
| Measure |
Control
n=113 Participants
Participants in the control group receive no study messages
|
Untailored Messages
n=108 Participants
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.
|
Tailored Messages
n=98 Participants
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.
|
|---|---|---|---|
|
Hookah Tobacco Use Frequency
|
4.3 days in the past month
Interval 3.0 to 5.6
|
4.0 days in the past month
Interval 2.6 to 5.2
|
3.5 days in the past month
Interval 2.0 to 5.0
|
PRIMARY outcome
Timeframe: 6 monthsHookah 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.
Outcome measures
| Measure |
Control
n=113 Participants
Participants in the control group receive no study messages
|
Untailored Messages
n=108 Participants
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.
|
Tailored Messages
n=98 Participants
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.
|
|---|---|---|---|
|
Percent of Participants Who Quit Smoking Hookah Tobacco
|
29.20 percentage of participants
|
37.96 percentage of participants
|
48.98 percentage of participants
|
Adverse Events
Control
Untailored Messages
Tailored Messages
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place