Trial Outcomes & Findings for Alcohol Health Education Among College Drinkers (NCT NCT03433794)
NCT ID: NCT03433794
Last Updated: 2020-12-01
Results Overview
Participant self-reported number of standard drinks consumed by participant over the past 2 weeks
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
537 participants
Primary outcome timeframe
Past 2 weeks, reported at Baseline assessment (pre-intervention)
Results posted on
2020-12-01
Participant Flow
Participants read study description and eligibility criteria, and signed up to attend a baseline session. Upon joining the study and completing an informed consent document, they were randomly assigned to arm/group of the study. After completing the online survey, 26 individuals were identified as ineligible and not enrolled.
Participant milestones
| Measure |
Control
The control group spent 60 minutes on an online education session (Lilly for Better Health) directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. Their email 2 weeks later contained only a reminder to participate in follow-up surveys.
Lilly for Better Health: This is an online education session directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. It was not expected to influence alcohol use.
|
Intervention Only
Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Their email 2 weeks later contained only a reminder to participate in follow-up surveys.
Alcohol 101 Plus (TM): It is a combination of several intervention components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where participants provide information such as sex, weight, and state so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The program provides updated BACs based upon choices about what to consume and how quickly to consume it. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. It is a non-linear environment, where participants choose which sections of the website to explore.
|
Intervention-plus-Booster
Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Importantly, their email 2 weeks later contained a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and reported harm reduction strategies.
Alcohol 101 Plus (TM): It is a combination of several components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do.
Booster: Content included sex-specific descriptive normative information, as well as reminders of harm reduction strategies.
|
|---|---|---|---|
|
Baseline
STARTED
|
183
|
173
|
181
|
|
Baseline
COMPLETED
|
183
|
173
|
181
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
0
|
|
2-Week Assessment
STARTED
|
183
|
173
|
181
|
|
2-Week Assessment
COMPLETED
|
117
|
112
|
109
|
|
2-Week Assessment
NOT COMPLETED
|
66
|
61
|
72
|
|
4-Week Assessment
STARTED
|
183
|
173
|
181
|
|
4-Week Assessment
COMPLETED
|
98
|
95
|
91
|
|
4-Week Assessment
NOT COMPLETED
|
85
|
78
|
90
|
|
6-Week Assessment
STARTED
|
183
|
173
|
181
|
|
6-Week Assessment
COMPLETED
|
94
|
85
|
80
|
|
6-Week Assessment
NOT COMPLETED
|
89
|
88
|
101
|
|
3-Month Assessment
STARTED
|
183
|
173
|
181
|
|
3-Month Assessment
COMPLETED
|
69
|
73
|
71
|
|
3-Month Assessment
NOT COMPLETED
|
114
|
100
|
110
|
|
6-Month Assessment
STARTED
|
183
|
173
|
181
|
|
6-Month Assessment
COMPLETED
|
65
|
58
|
50
|
|
6-Month Assessment
NOT COMPLETED
|
118
|
115
|
131
|
|
9-Month Assessment
STARTED
|
183
|
173
|
181
|
|
9-Month Assessment
COMPLETED
|
49
|
52
|
39
|
|
9-Month Assessment
NOT COMPLETED
|
134
|
121
|
142
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alcohol Health Education Among College Drinkers
Baseline characteristics by cohort
| Measure |
Control
n=183 Participants
The control group spent 60 minutes on an online education session (Lilly for Better Health) directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. Their email 2 weeks later contained only a reminder to participate in follow-up surveys.
Lilly for Better Health: This is an online education session directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. It was not expected to influence alcohol use.
|
Intervention Only
n=173 Participants
Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Their email 2 weeks later contained only a reminder to participate in follow-up surveys.
Alcohol 101 Plus (TM): It is a combination of several intervention components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where participants provide information such as sex, weight, and state so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The program provides updated BACs based upon choices about what to consume and how quickly to consume it. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. It is a non-linear environment, where participants choose which sections of the website to explore.
|
Intervention-plus-Booster
n=181 Participants
Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Importantly, their email 2 weeks later contained a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and reported harm reduction strategies.
Alcohol 101 Plus (TM): It is a combination of several components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do.
Booster: Content included sex-specific descriptive normative information, as well as reminders of harm reduction strategies.
|
Total
n=537 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
19.792 years
STANDARD_DEVIATION 1.779 • n=5 Participants
|
19.792 years
STANDARD_DEVIATION 1.726 • n=7 Participants
|
19.370 years
STANDARD_DEVIATION 1.476 • n=5 Participants
|
19.650 years
STANDARD_DEVIATION 1.674 • n=4 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
362 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian or White
|
82 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
262 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African-American or Black
|
74 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
201 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
non-Hispanic
|
158 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
479 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
183 participants
n=5 Participants
|
173 participants
n=7 Participants
|
181 participants
n=5 Participants
|
537 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Past 2 weeks, reported at Baseline assessment (pre-intervention)Participant self-reported number of standard drinks consumed by participant over the past 2 weeks
Outcome measures
| Measure |
Control
n=183 Participants
The control group spent 60 minutes on an online education session (Lilly for Better Health) directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. Their email 2 weeks later contained only a reminder to participate in follow-up surveys.
Lilly for Better Health: This is an online education session directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. It was not expected to influence alcohol use.
|
Intervention Only
n=173 Participants
Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Their email 2 weeks later contained only a reminder to participate in follow-up surveys.
Alcohol 101 Plus (TM): It is a combination of several intervention components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where participants provide information such as sex, weight, and state so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The program provides updated BACs based upon choices about what to consume and how quickly to consume it. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. It is a non-linear environment, where participants choose which sections of the website to explore.
|
Intervention-plus-Booster
n=181 Participants
Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Importantly, their email 2 weeks later contained a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and reported harm reduction strategies.
Alcohol 101 Plus (TM): It is a combination of several components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do.
Booster: Content included sex-specific descriptive normative information, as well as reminders of harm reduction strategies.
|
|---|---|---|---|
|
Alcohol Consumption
|
16.929 drinks
Standard Deviation 14.826
|
17.988 drinks
Standard Deviation 16.870
|
18.039 drinks
Standard Deviation 16.382
|
SECONDARY outcome
Timeframe: Past 2 weeks, reported at Baseline assessment (pre-intervention)Participant self-report on the Young Adult Alcohol Consequences Questionnaire (YAACQ; Read, Kahler, Strong, \& Colder, 2006), which assesses alcohol-related problems experienced by the participant. Total scores are created by summing all individual items, and range from 0 to 48, with higher values representing more problems experienced (i.e., worse outcomes).
Outcome measures
| Measure |
Control
n=183 Participants
The control group spent 60 minutes on an online education session (Lilly for Better Health) directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. Their email 2 weeks later contained only a reminder to participate in follow-up surveys.
Lilly for Better Health: This is an online education session directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. It was not expected to influence alcohol use.
|
Intervention Only
n=173 Participants
Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Their email 2 weeks later contained only a reminder to participate in follow-up surveys.
Alcohol 101 Plus (TM): It is a combination of several intervention components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where participants provide information such as sex, weight, and state so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The program provides updated BACs based upon choices about what to consume and how quickly to consume it. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. It is a non-linear environment, where participants choose which sections of the website to explore.
|
Intervention-plus-Booster
n=181 Participants
Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Importantly, their email 2 weeks later contained a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and reported harm reduction strategies.
Alcohol 101 Plus (TM): It is a combination of several components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do.
Booster: Content included sex-specific descriptive normative information, as well as reminders of harm reduction strategies.
|
|---|---|---|---|
|
Alcohol-related Consequences
|
6.656 problems
Standard Deviation 5.566
|
7.156 problems
Standard Deviation 6.066
|
7.011 problems
Standard Deviation 6.367
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention-plus-Booster
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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