Alcohol Metabolism and Disease Risk in Asians: Examining the Impact of Personalized Phenotypic/Genotypic Feedback and Motivational Processes on Early Drinking Trajectories
Phase: NA
Conditions: Healthy
Sponsor: University of Southern California

Protocol 
 
 
Alcohol Metabolism and Disease Risk in Asians  
 
 
 
NCT number NCT04967599 
Document Date 08/08/2024 
 
 
 

Protocol 
This exploratory/developmental pilot study uses a parallel study design with a brief online behavioral 
intervention component. Participants are 360 college students of Asian heritage recruited as two cohorts, a 
group of incoming first year college students and a group of college students already on campus who report 
having flushed when they first started drinking alcohol. After a baseline assessment including surveys and 
DNA collection for genotyping, participants are randomized in equal numbers into one of three feedback 
groups (n = 120 per group) based on lifetime drinking (Incoming cohort only) and having an ALDH2*2 allele: 1) 
Phenotype only (PHEN): this intervention provides information on health-related risk associated with alcohol 
consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and 
associated risks; 2) Phenotype and Genotype (PHEN+GENE): the PHEN intervention plus personalized 
feedback on alcohol metabolism genotypes and associated health-related risks; or 3) CONTROL: an attention 
control session that does not provide feedback included in PHEN or GENE. Participants then are followed in 
four post-intervention behavioral surveys over 10 months and in the final 10-month follow-up also complete an 
evaluation of the study and retention of the intervention information. Our alcohol outcome measures include 
peak quantity (primary) and secondary measures of drinking frequency, weekend drinking, and total amount of 
drinking. Additional secondary outcome behaviors include percent of time used flush cures when drinking and 
transition to drinking in initial non-drinkers.  
 
 

Data Analysis Plan 
 
 
Alcohol Metabolism and Disease Risk in Asians  
 
 
 
NCT number NCT04967599 
Document Date 08/08/2024 
 
 
 

Data Analysis Plan 
We conduct nonparametric group comparisons to test for group differences among the three intervention 
groups in our primary and secondary outcomes. For outcomes that are continuous (alcohol consumption 
measures), we conduct the Kruskal-Wallis test. For the non-drinker and the flush cure use outcomes that are 
categorical, we conduct either the uncorrected chi-squared test when all of the expected cell counts are at 
least 5, or the Fisher's exact test when any of the expected cell count is less than 5. We adjust the p-value for 
significance to a more conservative value of <.01 to adjust for multiple comparisons.