Trial Outcomes & Findings for Examining Alcohol Consumption, Perceptions, and User Experience of Alcohol Moderation Strategies (NCT NCT04286867)
NCT ID: NCT04286867
Last Updated: 2024-11-18
Results Overview
The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) will be used to assess negative consequences of alcohol use (24-items). Minimum score is 0, maximum is 24, with higher scores indicating more negative consequences of alcohol use.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
64 participants
Primary outcome timeframe
14 day window preceding baseline assessed at baseline, 14 day window assessed 14 days following baseline
Results posted on
2024-11-18
Participant Flow
Participant milestones
| Measure |
Alcohol Moderation Group 1
This group will receive a link and in-person instructions on how to use the alcohol moderation application described. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.
Alcohol Moderation Mobile Application: This group will receive a link and in-person instructions on how to use the alcohol moderation application described. Individuals in this group will define their drinking limits within the application. The application will provide time points to aid the individual in maintaining their predefined drinking limits throughout the course of the drinking occasion. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.
|
Alcohol Moderation Group 2
This group will receive the NIAAA tracking card and in-person instructions on how to use the drink tracker card (described at https://www.rethinkingdrinking.niaaa.nih.gov/Thinking-about-a-change/Strategies-for-cutting-down/Tips-To-Try.aspx). This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.
Alcohol Moderation Drink Tracker: This group will receive the NIAAA tracking card and in-person instructions on how to use the drink tracker card (described at https://www.rethinkingdrinking.niaaa.nih.gov/Thinking-about-a-change/Strategies-for-cutting-down/Tips-To-Try.aspx). Individuals in this group will define their drinking limits, and record their alcohol consumption on the drink tracking card. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Examining Alcohol Consumption, Perceptions, and User Experience of Alcohol Moderation Strategies
Baseline characteristics by cohort
| Measure |
Alcohol Moderation Group 1
n=29 Participants
This group will receive a link and in-person instructions on how to use the alcohol moderation application described. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.
Alcohol Moderation Mobile Application: This group will receive a link and in-person instructions on how to use the alcohol moderation application described. Individuals in this group will define their drinking limits within the application. The application will provide time points to aid the individual in maintaining their predefined drinking limits throughout the course of the drinking occasion. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.
|
Alcohol Moderation Group 2
n=30 Participants
This group will receive the NIAAA tracking card and in-person instructions on how to use the drink tracker card (described at https://www.rethinkingdrinking.niaaa.nih.gov/Thinking-about-a-change/Strategies-for-cutting-down/Tips-To-Try.aspx). This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.
Alcohol Moderation Drink Tracker: This group will receive the NIAAA tracking card and in-person instructions on how to use the drink tracker card (described at https://www.rethinkingdrinking.niaaa.nih.gov/Thinking-about-a-change/Strategies-for-cutting-down/Tips-To-Try.aspx). Individuals in this group will define their drinking limits, and record their alcohol consumption on the drink tracking card. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.11 years
STANDARD_DEVIATION 16.05 • n=93 Participants
|
38.41 years
STANDARD_DEVIATION 14.25 • n=4 Participants
|
37.77 years
STANDARD_DEVIATION 15.05 • n=27 Participants
|
|
Sex/Gender, Customized
Identified Gender · Female
|
23 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Identified Gender · Male
|
5 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Identified Gender · Identified as another gender
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=93 Participants
|
30 participants
n=4 Participants
|
59 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 14 day window preceding baseline assessed at baseline, 14 day window assessed 14 days following baselineThe Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) will be used to assess negative consequences of alcohol use (24-items). Minimum score is 0, maximum is 24, with higher scores indicating more negative consequences of alcohol use.
Outcome measures
| Measure |
Alcohol Moderation Group 1
n=29 Participants
This group will receive a link and in-person instructions on how to use the alcohol moderation application described. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.
Alcohol Moderation Mobile Application: This group will receive a link and in-person instructions on how to use the alcohol moderation application described. Individuals in this group will define their drinking limits within the application. The application will provide time points to aid the individual in maintaining their predefined drinking limits throughout the course of the drinking occasion. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.
|
Alcohol Moderation Group 2
n=30 Participants
This group will receive the NIAAA tracking card and in-person instructions on how to use the drink tracker card (described at https://www.rethinkingdrinking.niaaa.nih.gov/Thinking-about-a-change/Strategies-for-cutting-down/Tips-To-Try.aspx). This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.
Alcohol Moderation Drink Tracker: This group will receive the NIAAA tracking card and in-person instructions on how to use the drink tracker card (described at https://www.rethinkingdrinking.niaaa.nih.gov/Thinking-about-a-change/Strategies-for-cutting-down/Tips-To-Try.aspx). Individuals in this group will define their drinking limits, and record their alcohol consumption on the drink tracking card. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.
|
|---|---|---|
|
The Young Adult Alcohol Consequences Questionnaire
|
-4.48 outcome score minus baseline score
Standard Deviation 4.07
|
-4.63 outcome score minus baseline score
Standard Deviation 3.97
|
PRIMARY outcome
Timeframe: 14 day window preceding baseline assessed at baseline, 14 day window assessed 14 days following baselineA daily alcohol use diary will be provided for the two-week observation period. Participants will be trained on how to use the diary during the baseline laboratory session. Number of standard drinks per drinking day will be calculated from the daily diary alcohol consumption records (total number of standard drinks consumed / number of drinking days).
Outcome measures
| Measure |
Alcohol Moderation Group 1
n=28 Participants
This group will receive a link and in-person instructions on how to use the alcohol moderation application described. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.
Alcohol Moderation Mobile Application: This group will receive a link and in-person instructions on how to use the alcohol moderation application described. Individuals in this group will define their drinking limits within the application. The application will provide time points to aid the individual in maintaining their predefined drinking limits throughout the course of the drinking occasion. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.
|
Alcohol Moderation Group 2
n=30 Participants
This group will receive the NIAAA tracking card and in-person instructions on how to use the drink tracker card (described at https://www.rethinkingdrinking.niaaa.nih.gov/Thinking-about-a-change/Strategies-for-cutting-down/Tips-To-Try.aspx). This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.
Alcohol Moderation Drink Tracker: This group will receive the NIAAA tracking card and in-person instructions on how to use the drink tracker card (described at https://www.rethinkingdrinking.niaaa.nih.gov/Thinking-about-a-change/Strategies-for-cutting-down/Tips-To-Try.aspx). Individuals in this group will define their drinking limits, and record their alcohol consumption on the drink tracking card. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.
|
|---|---|---|
|
Number of Standard Drinks Consumed Per Drinking Day
|
-.618 change in standard drinks
Standard Deviation 1.81
|
-.955 change in standard drinks
Standard Deviation 2.21
|
Adverse Events
Alcohol Moderation Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alcohol Moderation Group 2
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