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

NCT04286867 | Completed Phase 1 Results

• 1 other identifier: 18-199
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Abuse; Alcohol Use Disorder; Alcohol Abuse, Episodic

Outcome Measures

Primary Outcomes (2)

• 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.

  14 day window preceding baseline assessed at baseline, 14 day window assessed 14 days following baseline

• 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).

  14 day window preceding baseline assessed at baseline, 14 day window assessed 14 days following baseline

Study Arms (2)

Alcohol Moderation Group 1

EXPERIMENTAL

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.

Other: Alcohol Moderation Mobile Application

Alcohol Moderation Group 2

ACTIVE COMPARATOR

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.

Behavioral: Alcohol Moderation Drink Tracker

Interventions

Alcohol Moderation Mobile Application OTHER

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 1

Alcohol Moderation Drink Tracker BEHAVIORAL

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.

Alcohol Moderation Group 2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• seeking treatment for alcohol use from a health-care provider
• younger than age 21

Sponsors & Collaborators

• Kent State University: lead

Study Sites (1)

Kent State University

Kent, Ohio, 44240, United States

Location

MeSH Terms

Conditions

Alcoholism; Recurrence

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: William Lechner
• Organization: Kent State University

wlechner@kent.edu

8144501093

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: February 27, 2020
• Study Start: February 5, 2020
• Primary Completion: May 10, 2022
• Study Completion: May 10, 2022
• Last Updated: November 18, 2024
• Results First Posted: November 18, 2024

Record last verified: 2024-09

Locations

US (1)