Healthy
Conditions
Brief summary
The primary pathway of alcohol metabolism involves two main enzymes, alcohol and aldehyde dehydrogenase. Several genes that encode these enzymes have variants that alter the rate of alcohol metabolism and increase levels of acetaldehyde. The variant ALDH2\*2 allele is associated with the flushing response (i.e., Asian glow) and is found almost exclusively in individuals of east Asian descent. Although having variant ALDH2 alleles is protective against heavy drinking and alcohol use disorders, for those who do drink, these variants also are associated with elevations in risk for several health problems. The premise of this study is that we can affect early drinking behavior through personalized communication about these health-related risks.
Interventions
BEHAVIORALPhenotype Feedback Intervention
Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
BEHAVIORALGenotype Feedback Intervention
Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks.
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* All participants will be of Asian heritage (i.e. Chinese/Taiwanese, Japanese, Korean, Vietnamese). * About half of the sample will be incoming first-year undergraduates * About half of the sample will be current undergraduates who self-report having flushed when they first started drinking alcohol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Number of Alcohol Drinks Consumed in a Day | Baseline through 10-months post-intervention (which occurred on 1 day) | Drinking quantity (i.e. total number of alcoholic drinks) consumed on heaviest drinking day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Drinking Days | Baseline through 10-months post-intervention (which occurred on 1 day) | Number of days consumed alcohol in the past month |
| Number of Alcoholic Drinks Consumed on Weekend | Baseline through 10-months post-intervention (which occurred on 1 day) | Alcohol quantity (total number of drinks) consumed on a typical drinking weekend |
| Number of Alcoholic Drinks Consumed Weekly | Baseline through 10-months post-intervention (which occurred on 1 day) | Total quantity (i.e. number of drinks) of alcohol consumed in a typical drinking week |
| Number of Participants Identified as Non-drinkers | Baseline through 10-months post-intervention (which occurred on 1 day) | Number of Participants Identified as Non-drinkers (i.e. have not had alcohol beyond small sips or tastes) |
| Alcohol Flush Cure Use Rate | Baseline through 10-months post-intervention (which occurred on 1 day) | Proportion of time used a product to reduce flushing when drinking alcohol |
Countries
United States
Participant flow
Recruitment details
Participants were recruited July to October 2021 as a college student sample in Los Angeles
Pre-assignment details
All 360 participants were assigned to a group.
Participants by arm
| Arm | Count |
|---|---|
| Control (CONTROL) Participants do not receive PHEN or GENE. | 120 |
| Phenotype Feedback (PHEN) Participants receive the PHEN intervention.
Phenotype Feedback Intervention: Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks. | 120 |
| Phenotype and Genotype Feedback (PHEN+GENE) Participants receive the PHEN and GENE interventions.
Phenotype Feedback Intervention: Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
Genotype Feedback Intervention: Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks. | 120 |
| Total | 360 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 35 | 19 | 23 |
Baseline characteristics
| Characteristic | Control (CONTROL) | Total | Phenotype and Genotype Feedback (PHEN+GENE) | Phenotype Feedback (PHEN) |
|---|---|---|---|---|
| Age, Continuous | 18.7 years STANDARD_DEVIATION 1.1 | 18.8 years STANDARD_DEVIATION 1.2 | 18.6 years STANDARD_DEVIATION 1.2 | 19.1 years STANDARD_DEVIATION 1.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 115 Participants | 338 Participants | 112 Participants | 111 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 22 Participants | 8 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 120 participants | 360 participants | 120 participants | 120 participants |
| Sex: Female, Male Female | 66 Participants | 208 Participants | 74 Participants | 68 Participants |
| Sex: Female, Male Male | 54 Participants | 152 Participants | 46 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Peak Number of Alcohol Drinks Consumed in a Day
Drinking quantity (i.e. total number of alcoholic drinks) consumed on heaviest drinking day
Time frame: Baseline through 10-months post-intervention (which occurred on 1 day)
Population: 360 participants were in the baseline assessment, 280 had this outcome in the 10-month follow-up assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control (CONTROL) | Peak Number of Alcohol Drinks Consumed in a Day | Baseline | 3.7 drinks | Standard Deviation 3.5 |
| Control (CONTROL) | Peak Number of Alcohol Drinks Consumed in a Day | 10-month follow-up | 3.0 drinks | Standard Deviation 2.9 |
| Phenotype Feedback (PHEN) | Peak Number of Alcohol Drinks Consumed in a Day | Baseline | 4.2 drinks | Standard Deviation 4.1 |
| Phenotype Feedback (PHEN) | Peak Number of Alcohol Drinks Consumed in a Day | 10-month follow-up | 2.8 drinks | Standard Deviation 2.7 |
| Phenotype and Genotype Feedback (PHEN+GENE) | Peak Number of Alcohol Drinks Consumed in a Day | Baseline | 3.4 drinks | Standard Deviation 3 |
| Phenotype and Genotype Feedback (PHEN+GENE) | Peak Number of Alcohol Drinks Consumed in a Day | 10-month follow-up | 3.2 drinks | Standard Deviation 3.5 |
p-value: 0.81Kruskal-Wallis
Secondary
Alcohol Flush Cure Use Rate
Proportion of time used a product to reduce flushing when drinking alcohol
Time frame: Baseline through 10-months post-intervention (which occurred on 1 day)
Population: 311 participants in the baseline assessment and 220 in the 10-month follow-up assessment were current drinkers and could have used a flush cure (i.e. taken a substance to reduce flushing when drinking alcohol)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Control (CONTROL) | Alcohol Flush Cure Use Rate | Baseline | Half of the time or more used a flush cure | 3 Participants |
| Control (CONTROL) | Alcohol Flush Cure Use Rate | 10-month follow-up | Half of the time or more used a flush cure | 2 Participants |
| Control (CONTROL) | Alcohol Flush Cure Use Rate | 10-month follow-up | Some of the time used a flush cure | 5 Participants |
| Control (CONTROL) | Alcohol Flush Cure Use Rate | Baseline | Almost never/never used a flush cure | 97 Participants |
| Control (CONTROL) | Alcohol Flush Cure Use Rate | Baseline | Some of the time used a flush cure | 7 Participants |
| Control (CONTROL) | Alcohol Flush Cure Use Rate | 10-month follow-up | Almost never/never used a flush cure | 61 Participants |
| Phenotype Feedback (PHEN) | Alcohol Flush Cure Use Rate | Baseline | Some of the time used a flush cure | 6 Participants |
| Phenotype Feedback (PHEN) | Alcohol Flush Cure Use Rate | Baseline | Almost never/never used a flush cure | 91 Participants |
| Phenotype Feedback (PHEN) | Alcohol Flush Cure Use Rate | Baseline | Half of the time or more used a flush cure | 4 Participants |
| Phenotype Feedback (PHEN) | Alcohol Flush Cure Use Rate | 10-month follow-up | Some of the time used a flush cure | 2 Participants |
| Phenotype Feedback (PHEN) | Alcohol Flush Cure Use Rate | 10-month follow-up | Almost never/never used a flush cure | 67 Participants |
| Phenotype Feedback (PHEN) | Alcohol Flush Cure Use Rate | 10-month follow-up | Half of the time or more used a flush cure | 5 Participants |
| Phenotype and Genotype Feedback (PHEN+GENE) | Alcohol Flush Cure Use Rate | Baseline | Almost never/never used a flush cure | 94 Participants |
| Phenotype and Genotype Feedback (PHEN+GENE) | Alcohol Flush Cure Use Rate | 10-month follow-up | Half of the time or more used a flush cure | 3 Participants |
| Phenotype and Genotype Feedback (PHEN+GENE) | Alcohol Flush Cure Use Rate | 10-month follow-up | Almost never/never used a flush cure | 73 Participants |
| Phenotype and Genotype Feedback (PHEN+GENE) | Alcohol Flush Cure Use Rate | Baseline | Half of the time or more used a flush cure | 6 Participants |
| Phenotype and Genotype Feedback (PHEN+GENE) | Alcohol Flush Cure Use Rate | Baseline | Some of the time used a flush cure | 3 Participants |
| Phenotype and Genotype Feedback (PHEN+GENE) | Alcohol Flush Cure Use Rate | 10-month follow-up | Some of the time used a flush cure | 2 Participants |
p-value: 0.49Fisher Exact
Secondary
Number of Alcoholic Drinks Consumed on Weekend
Alcohol quantity (total number of drinks) consumed on a typical drinking weekend
Time frame: Baseline through 10-months post-intervention (which occurred on 1 day)
Population: 360 participants were in the baseline assessment, 269 of whom reported on this variable in the 10-month follow-up assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control (CONTROL) | Number of Alcoholic Drinks Consumed on Weekend | Baseline | 2.7 drinks | Standard Deviation 4.2 |
| Control (CONTROL) | Number of Alcoholic Drinks Consumed on Weekend | 10-month follow-up | 2.1 drinks | Standard Deviation 3.8 |
| Phenotype Feedback (PHEN) | Number of Alcoholic Drinks Consumed on Weekend | Baseline | 3.1 drinks | Standard Deviation 4.4 |
| Phenotype Feedback (PHEN) | Number of Alcoholic Drinks Consumed on Weekend | 10-month follow-up | 1.9 drinks | Standard Deviation 3 |
| Phenotype and Genotype Feedback (PHEN+GENE) | Number of Alcoholic Drinks Consumed on Weekend | Baseline | 2.7 drinks | Standard Deviation 3.6 |
| Phenotype and Genotype Feedback (PHEN+GENE) | Number of Alcoholic Drinks Consumed on Weekend | 10-month follow-up | 2.7 drinks | Standard Deviation 4.2 |
p-value: 0.49Kruskal-Wallis
Secondary
Number of Alcoholic Drinks Consumed Weekly
Total quantity (i.e. number of drinks) of alcohol consumed in a typical drinking week
Time frame: Baseline through 10-months post-intervention (which occurred on 1 day)
Population: 360 participants were in the baseline assessment, 269 of whom reported this variable in the 10-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control (CONTROL) | Number of Alcoholic Drinks Consumed Weekly | Baseline | 3.2 drinks | Standard Deviation 4.6 |
| Control (CONTROL) | Number of Alcoholic Drinks Consumed Weekly | 10-month follow-up | 2.8 drinks | Standard Deviation 5.8 |
| Phenotype Feedback (PHEN) | Number of Alcoholic Drinks Consumed Weekly | Baseline | 4.0 drinks | Standard Deviation 5.6 |
| Phenotype Feedback (PHEN) | Number of Alcoholic Drinks Consumed Weekly | 10-month follow-up | 2.2 drinks | Standard Deviation 3.4 |
| Phenotype and Genotype Feedback (PHEN+GENE) | Number of Alcoholic Drinks Consumed Weekly | Baseline | 2.9 drinks | Standard Deviation 4.1 |
| Phenotype and Genotype Feedback (PHEN+GENE) | Number of Alcoholic Drinks Consumed Weekly | 10-month follow-up | 2.7 drinks | Standard Deviation 4.2 |
p-value: 0.59Kruskal-Wallis
Secondary
Number of Drinking Days
Number of days consumed alcohol in the past month
Time frame: Baseline through 10-months post-intervention (which occurred on 1 day)
Population: 360 participants were in the baseline assessment, 279 of whom reported this variable in the 10-month follow-up assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control (CONTROL) | Number of Drinking Days | Baseline | 2.4 days | Standard Deviation 1.8 |
| Control (CONTROL) | Number of Drinking Days | 10-month follow-up | 2.3 days | Standard Deviation 1.9 |
| Phenotype Feedback (PHEN) | Number of Drinking Days | Baseline | 2.3 days | Standard Deviation 1.8 |
| Phenotype Feedback (PHEN) | Number of Drinking Days | 10-month follow-up | 2.0 days | Standard Deviation 1.8 |
| Phenotype and Genotype Feedback (PHEN+GENE) | Number of Drinking Days | Baseline | 2.3 days | Standard Deviation 1.8 |
| Phenotype and Genotype Feedback (PHEN+GENE) | Number of Drinking Days | 10-month follow-up | 2.2 days | Standard Deviation 1.8 |
p-value: 0.46Kruskal-Wallis
Secondary
Number of Participants Identified as Non-drinkers
Number of Participants Identified as Non-drinkers (i.e. have not had alcohol beyond small sips or tastes)
Time frame: Baseline through 10-months post-intervention (which occurred on 1 day)
Population: 360 participants were in the baseline assessment, 280 of whom reported on this variable in the 10-month follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control (CONTROL) | Number of Participants Identified as Non-drinkers | Baseline | 14 Participants |
| Control (CONTROL) | Number of Participants Identified as Non-drinkers | 10-month follow-up | 4 Participants |
| Phenotype Feedback (PHEN) | Number of Participants Identified as Non-drinkers | Baseline | 15 Participants |
| Phenotype Feedback (PHEN) | Number of Participants Identified as Non-drinkers | 10-month follow-up | 9 Participants |
| Phenotype and Genotype Feedback (PHEN+GENE) | Number of Participants Identified as Non-drinkers | Baseline | 16 Participants |
| Phenotype and Genotype Feedback (PHEN+GENE) | Number of Participants Identified as Non-drinkers | 10-month follow-up | 4 Participants |
p-value: 0.29Fisher Exact