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Examining Alcohol Consumption, Perceptions, and User Experience of Alcohol Moderation Strategies

Examining Alcohol Consumption, Perceptions, and User Experience of Alcohol Moderation Strategies

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04286867
Acronym
ALCMOD
Enrollment
64
Registered
2020-02-27
Start date
2020-02-05
Completion date
2022-05-10
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Abuse, Alcohol Abuse, Episodic, Alcohol Use Disorder

Brief summary

The primary aims of the study are to assess the user experience and initial efficacy of a mobile application designed to reduce problematic alcohol use. The application utilizes drinking limits, defined by the user, to pace alcohol consumption during drinking occasions. The mobile application will be compared to strategies for tracking drinking detailed within the National Institute on Alcohol Abuse and Alcoholism Alcohol Moderation Strategies (https://www.rethinkingdrinking.niaaa.nih.gov/thinking-about-a-change/strategies-for-cutting-down/tips-to-try.aspx). Primary outcome variables, in addition to variables assessing user design experience of the application and use of moderation strategies, include (1) negative consequences of alcohol use during a 14 day observation period, and (2) number of drinks consumed per drinking day during a 14 day observation period.

Detailed description

The mobile application to be tested provides guidance on moderating alcohol use in real time based on individual user's pre-defined drinking limits. This mobile application will be compared to a drink tracking strategy and corresponding tool outlined within the National Institute on Alcohol Abuse and Alcoholism Alcohol Moderation Strategies (https://www.rethinkingdrinking.niaaa.nih.gov/thinking-about-a-change/strategies-for-cutting-down/tips-to-try.aspx). Participants will be recruited from the community in Northeastern Ohio. Eligible participants will meet the following inclusion criteria 1) be age 21 or older, 2) report experiencing at least three negative consequence of alcohol use in the past month (assessed via Brief Young Adult Alcohol Consequences Questionnaire: BYAACQ), 3) report having consumed at least 5 drinks (for men) or 4 drinks (for women) on one or more occasions in the past 2-weeks, 4) not be seeking treatment for alcohol use from a health-care provider, and 5) have access to a smartphone and 6) endorse some importance in changing their drinking (2 or greater on Alcohol Ladder Scale Importance to Change). Participants who endorse seeking treatment for alcohol related problems from a health care provider will be provided with a list of university sponsored and community based treatment providers, and excluded. Participants (n=64) will complete a battery of assessments including demographic measures, alcohol and substance use measures, psychological measures, behavioral economic and neuropsychological measures. The Timeline Follow-back Interview will be used to assess alcohol use. The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ ) will be used to assess a range of negative consequences of alcohol use that young adults may experience (e.g., while drinking in the past month, I have said or done embarrassing things). Following this initial baseline assessment, participants will be randomized to one of two experimental conditions detailed below (Alcohol Moderation Group 1 and 2). Doctoral Candidates in Clinical Psychology will review strategies for moderating alcohol use with all participants (strategies recommended by the National Institute on Alcohol Abuse and Alcoholism; detail included as supplement). The only variation in the discussion of strategies is the the Alcohol Moderation Group 1 will receive detail and training on how to use the mobile application; whereas, the Alcohol Moderation Group 2 will receive detail and training on how to use the drinking tracker card recommended within the NIAAA guidelines. Primary outcome variables, in addition to variables assessing user design experience of the application and use of moderation strategies, will include (1) negative consequences of alcohol use during a 14 day observation period following randomization, and (2) number of drinks consumed per drinking day during a 14 day observation period following randomization. Assessment of primary outcome variable (1) will include baseline negative consequences of alcohol use (BYAACQ score) during the 14 day period prior to randomization as a covariate as well as additional covariates defined a priori based on the extant literature. Assessment of primary outcome variable (2) will include consideration of average drinking limit for each drinking day defined by the user, and number of drinks per drinking day in a 14 day period prior to randomization, as well as covariates defined a priori based on the extant literature.

Interventions

OTHERAlcohol 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.

BEHAVIORALAlcohol 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.

Sponsors

Kent State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

All participants are told they will receive information about strategies and tools to reduce alcohol consumption. The participants will not be told whether they are receiving the novel method for reducing alcohol consumption or previously developed and studies methods for reducing alcohol consumption.

Intervention model description

Two groups are defined and compared in terms of primary outcome measures.

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. must report experiencing at least three negative consequences of alcohol use in the past month (assessed via Brief Young Adult Alcohol Consequences Questionnaire: BYAACQ) 2. have access to a smartphone 3. endorse importance in changing their drinking (2 or greater on Alcohol Ladder Scale Importance to Change) 4. report having consumed at least 5 drinks (for men) or 4 drinks (for women) on one or more occasions in the past 2-weeks

Exclusion criteria

1. seeking treatment for alcohol use from a health-care provider 2. younger than age 21

Design outcomes

Primary

MeasureTime frameDescription
The Young Adult Alcohol Consequences Questionnaire14 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.
Number of Standard Drinks Consumed Per Drinking Day14 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
29
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.
30
Total59

Baseline characteristics

CharacteristicAlcohol Moderation Group 1TotalAlcohol Moderation Group 2
Age, Continuous37.11 years
STANDARD_DEVIATION 16.05
37.77 years
STANDARD_DEVIATION 15.05
38.41 years
STANDARD_DEVIATION 14.25
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants3 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
28 Participants56 Participants28 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
27 Participants54 Participants27 Participants
Region of Enrollment
United States
29 participants59 participants30 participants
Sex/Gender, Customized
Identified Gender
Female
23 Participants44 Participants21 Participants
Sex/Gender, Customized
Identified Gender
Identified as another gender
1 Participants1 Participants0 Participants
Sex/Gender, Customized
Identified Gender
Male
5 Participants14 Participants9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 290 / 30
other
Total, other adverse events
0 / 290 / 30
serious
Total, serious adverse events
0 / 290 / 30

Outcome results

Primary

Number of Standard Drinks Consumed Per Drinking Day

A 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).

Time frame: 14 day window preceding baseline assessed at baseline, 14 day window assessed 14 days following baseline

ArmMeasureValue (MEAN)Dispersion
Alcohol Moderation Group 1Number of Standard Drinks Consumed Per Drinking Day-.618 change in standard drinksStandard Deviation 1.81
Alcohol Moderation Group 2Number of Standard Drinks Consumed Per Drinking Day-.955 change in standard drinksStandard Deviation 2.21
Primary

The Young Adult Alcohol Consequences Questionnaire

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.

Time frame: 14 day window preceding baseline assessed at baseline, 14 day window assessed 14 days following baseline

ArmMeasureValue (MEAN)Dispersion
Alcohol Moderation Group 1The Young Adult Alcohol Consequences Questionnaire-4.48 outcome score minus baseline scoreStandard Deviation 4.07
Alcohol Moderation Group 2The Young Adult Alcohol Consequences Questionnaire-4.63 outcome score minus baseline scoreStandard Deviation 3.97

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026