Trial Outcomes & Findings for Alcohol Health Education With Personalized Feedback Boosters (NCT NCT03440463)
NCT ID: NCT03440463
Last Updated: 2023-06-22
Results Overview
Participant self-reported number of standard drinks consumed by participant in a typical week.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
528 participants
Primary outcome timeframe
Past 30 days (3 months post-intervention)
Results posted on
2023-06-22
Participant Flow
Participant milestones
| Measure |
Intervention-only Control
Participants navigate through e-checkup to go, the well-established alcohol intervention. Their email 2 weeks later contains only a reminder to participate in follow-up surveys.
e-checkup to go: The e-checkup to go substance program is designed to motivate individuals to reduce their consumption using personalized information about their own use and risk factors. The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It is self-guided and requires no face-to-face time with an administrator. It provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.
|
Intervention Plus Norms-only Booster
Participants navigate through e-checkup to go, the well-established alcohol intervention. Their email 2 weeks later contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and their own use.
e-checkup to go: The e-checkup to go substance program is designed to motivate individuals to reduce their consumption using personalized information about their own use and risk factors. The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It is self-guided and requires no face-to-face time with an administrator. It provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.
Norms-only booster: Booster emails will contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, their own reported consumption, and how they compare.
|
Intervention Plus Norms-plus-Strategies Booster
Participants navigate through e-checkup to go, the well-established alcohol intervention. Their email 2 weeks later contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and their own use. It also includes reported harm reduction strategies, and other strategies they might consider.
e-checkup to go: The e-checkup to go program is designed to motivate individuals to reduce their consumption using personalized information about their own use and risk factors. The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It is self-guided and provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.
Norms-plus-Strategies booster: Booster emails contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, and their own reported consumption. These emails also contain reminders of strategies they can use to protect themselves from alcohol-related harm, both ones they've reported using in the past and others they might consider using in the future.
|
|---|---|---|---|
|
Baseline
STARTED
|
201
|
163
|
164
|
|
Baseline
COMPLETED
|
201
|
163
|
164
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
0
|
|
1-month Follow-up
STARTED
|
201
|
163
|
164
|
|
1-month Follow-up
COMPLETED
|
134
|
113
|
107
|
|
1-month Follow-up
NOT COMPLETED
|
67
|
50
|
57
|
|
3-month Follow-up
STARTED
|
201
|
163
|
164
|
|
3-month Follow-up
COMPLETED
|
117
|
89
|
96
|
|
3-month Follow-up
NOT COMPLETED
|
84
|
74
|
68
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alcohol Health Education With Personalized Feedback Boosters
Baseline characteristics by cohort
| Measure |
Intervention-only Control
n=201 Participants
Participants navigate through e-checkup to go, the well-established alcohol intervention. Their email 2 weeks later contains only a reminder to participate in follow-up surveys.
e-checkup to go: The e-checkup to go substance program is designed to motivate individuals to reduce their consumption using personalized information about their own use and risk factors. The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It is self-guided and requires no face-to-face time with an administrator. It provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.
|
Intervention Plus Norms-only Booster
n=163 Participants
Participants navigate through e-checkup to go, the well-established alcohol intervention. Their email 2 weeks later contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and their own use.
e-checkup to go: The e-checkup to go substance program is designed to motivate individuals to reduce their consumption using personalized information about their own use and risk factors. The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It is self-guided and requires no face-to-face time with an administrator. It provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.
Norms-only booster: Booster emails will contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, their own reported consumption, and how they compare.
|
Intervention Plus Norms-plus-Strategies Booster
n=164 Participants
Participants navigate through e-checkup to go, the well-established alcohol intervention. Their email 2 weeks later contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and their own use. It also includes reported harm reduction strategies, and other strategies they might consider.
e-checkup to go: The e-checkup to go program is designed to motivate individuals to reduce their consumption using personalized information about their own use and risk factors. The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It is self-guided and provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.
Norms-plus-Strategies booster: Booster emails contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, and their own reported consumption. These emails also contain reminders of strategies they can use to protect themselves from alcohol-related harm, both ones they've reported using in the past and others they might consider using in the future.
|
Total
n=528 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
19.80 years
STANDARD_DEVIATION 1.66 • n=5 Participants
|
19.75 years
STANDARD_DEVIATION 1.53 • n=7 Participants
|
20.02 years
STANDARD_DEVIATION 1.74 • n=5 Participants
|
19.85 years
STANDARD_DEVIATION 1.65 • n=4 Participants
|
|
Sex/Gender, Customized
Male
|
51 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
149 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
150 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
378 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
176 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
467 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
80 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
233 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
67 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
166 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
20 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Drinks per typical week (quantity)
|
8.18 drinks per week
STANDARD_DEVIATION 8.41 • n=5 Participants
|
6.72 drinks per week
STANDARD_DEVIATION 7.14 • n=7 Participants
|
8.05 drinks per week
STANDARD_DEVIATION 10.32 • n=5 Participants
|
7.69 drinks per week
STANDARD_DEVIATION 8.71 • n=4 Participants
|
|
Drinking days per typical week (frequency)
|
2.24 drinking days per week
STANDARD_DEVIATION 1.25 • n=5 Participants
|
1.96 drinking days per week
STANDARD_DEVIATION 1.13 • n=7 Participants
|
2.23 drinking days per week
STANDARD_DEVIATION 1.32 • n=5 Participants
|
2.15 drinking days per week
STANDARD_DEVIATION 1.24 • n=4 Participants
|
|
Highest drinking occasion in a typical week (peak)
|
4.01 drinks per day
STANDARD_DEVIATION 2.98 • n=5 Participants
|
3.48 drinks per day
STANDARD_DEVIATION 2.55 • n=7 Participants
|
3.71 drinks per day
STANDARD_DEVIATION 3.20 • n=5 Participants
|
3.76 drinks per day
STANDARD_DEVIATION 2.93 • n=4 Participants
|
|
Alcohol-related consequences (problems)
|
6.21 score on a scale
STANDARD_DEVIATION 6.59 • n=5 Participants
|
6.07 score on a scale
STANDARD_DEVIATION 7.05 • n=7 Participants
|
6.28 score on a scale
STANDARD_DEVIATION 7.17 • n=5 Participants
|
6.19 score on a scale
STANDARD_DEVIATION 6.91 • n=4 Participants
|
PRIMARY outcome
Timeframe: Past 30 days (3 months post-intervention)Population: Participants who completed the follow-up survey 3 months post-intervention.
Participant self-reported number of standard drinks consumed by participant in a typical week.
Outcome measures
| Measure |
Intervention-only Control
n=117 Participants
Participants navigate through e-checkup to go, the well-established alcohol intervention. Their email 2 weeks later contains only a reminder to participate in follow-up surveys.
e-checkup to go: The e-checkup to go substance program is designed to motivate individuals to reduce their consumption using personalized information about their own use and risk factors. The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It is self-guided and requires no face-to-face time with an administrator. It provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.
|
Intervention Plus Norms-only Booster
n=89 Participants
Participants navigate through e-checkup to go, the well-established alcohol intervention. Their email 2 weeks later contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and their own use.
e-checkup to go: The e-checkup to go substance program is designed to motivate individuals to reduce their consumption using personalized information about their own use and risk factors. The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It is self-guided and requires no face-to-face time with an administrator. It provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.
Norms-only booster: Booster emails will contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, their own reported consumption, and how they compare.
|
Intervention Plus Norms-plus-Strategies Booster
n=96 Participants
Participants navigate through e-checkup to go, the well-established alcohol intervention. Their email 2 weeks later contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and their own use. It also includes reported harm reduction strategies, and other strategies they might consider.
e-checkup to go: The e-checkup to go program is designed to motivate individuals to reduce their consumption using personalized information about their own use and risk factors. The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It is self-guided and provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.
Norms-plus-Strategies booster: Booster emails contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, and their own reported consumption. These emails also contain reminders of strategies they can use to protect themselves from alcohol-related harm, both ones they've reported using in the past and others they might consider using in the future.
|
|---|---|---|---|
|
Alcohol Consumption at 3 Months Post-intervention
|
4.08 drinks per week
Standard Deviation 5.81
|
4.15 drinks per week
Standard Deviation 5.71
|
4.89 drinks per week
Standard Deviation 7.68
|
SECONDARY outcome
Timeframe: Past 30 days (3 months post-intervention)Population: Participants who completed the follow-up survey 3 months post-intervention.
Assessed via the "Young Adult Alcohol Consequences Questionnaire" (Read et al., 2006). Participants indicate if they experienced an alcohol-related problem with a yes (=1) or no (=0). Scores are created by summing across all 48 items (range 0 to 48), where higher scores indicate experiencing more alcohol-related consequences/problems. Read, J. P., Kahler, C. W., Strong, D. R., \& Colder, C. R. (2006). Development and preliminary validation of the young adult alcohol consequences questionnaire. Journal of Studies on Alcohol, 67, 169-177. doi:10.15288/jsa.2006.67.169
Outcome measures
| Measure |
Intervention-only Control
n=117 Participants
Participants navigate through e-checkup to go, the well-established alcohol intervention. Their email 2 weeks later contains only a reminder to participate in follow-up surveys.
e-checkup to go: The e-checkup to go substance program is designed to motivate individuals to reduce their consumption using personalized information about their own use and risk factors. The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It is self-guided and requires no face-to-face time with an administrator. It provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.
|
Intervention Plus Norms-only Booster
n=89 Participants
Participants navigate through e-checkup to go, the well-established alcohol intervention. Their email 2 weeks later contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and their own use.
e-checkup to go: The e-checkup to go substance program is designed to motivate individuals to reduce their consumption using personalized information about their own use and risk factors. The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It is self-guided and requires no face-to-face time with an administrator. It provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.
Norms-only booster: Booster emails will contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, their own reported consumption, and how they compare.
|
Intervention Plus Norms-plus-Strategies Booster
n=96 Participants
Participants navigate through e-checkup to go, the well-established alcohol intervention. Their email 2 weeks later contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and their own use. It also includes reported harm reduction strategies, and other strategies they might consider.
e-checkup to go: The e-checkup to go program is designed to motivate individuals to reduce their consumption using personalized information about their own use and risk factors. The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It is self-guided and provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.
Norms-plus-Strategies booster: Booster emails contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, and their own reported consumption. These emails also contain reminders of strategies they can use to protect themselves from alcohol-related harm, both ones they've reported using in the past and others they might consider using in the future.
|
|---|---|---|---|
|
Alcohol-related Consequences 3 Months Post-intervention
|
3.27 score on a scale
Standard Deviation 5.68
|
2.37 score on a scale
Standard Deviation 3.73
|
2.67 score on a scale
Standard Deviation 4.11
|
Adverse Events
Intervention-only Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Plus Norms-only Booster
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Plus Norms-plus-Strategies 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