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CompletedNCT07126613Updated Jan 21, 2026

Mobile Alcohol Use Intervention

An interventional study of Mobile Health Intervention to Reduce Alcohol Use Among Young Adults in Alcohol Misuse, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-01-21.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study summary

This study aims to examine the feasibility and acceptability of a mobile health intervention to reduce alcohol use and related consequences among young adults. Participants will be randomly assigned to either receive access to the mobile health intervention or receive only generic study surveys. Participants will receive text message surveys sent to their personal cellphone for 4 weeks per their assigned trial arm. All participants will receive a post-survey 30 days after their final weekly survey text.

Read the detailed description

This study aims to determine whether a mobile health intervention to reduce alcohol use and related consequences is acceptable and feasible among young adults who engage in high-intensity drinking (HID; 8+/10+ drinks per drinking occasion for females/males, respectively). The investigators aim to recruit 40 adults between 18-25 years of age who report at least one HID episode in the past 30 days.

After providing informed consent, participants will be randomly assigned to receive the mobile health intervention or control surveys only.

Participants will attend one online study visit to enroll in the study and be assigned to their study arm. All subsequent study activities will be completed asynchronously. Participants will then receive text message prompts and/or surveys to their personal cellphone either Wednesday or Thursday through Sunday for four consecutive weeks. Participants will receive a post-test survey 30 days after their final weekly survey.

02

Conditions studied

  • Alcohol Misuse
03

In context

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18-25
  • Experience at least one high-intensity drinking episode in the past 30 days
  • Able to read and write in English
  • Consent to receiving text messages to personal cellphone
  • No current history of substance use treatment in the past 12 months
  • Did not participate in the Aim 2 technical field trial of the intervention

Exclusion criteria

Exclusion Criteria:

  • Under 18 or over 25
  • Did not experience at least one high-intensity drinking episode in the past 30 days
  • Unable to read and write in English
  • Does not consent to receive text messages to personal cellphone
  • Current or history of substance use treatment in the past 12 months
  • Participated in the Aim 2 technical field trial of the intervention
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Mobile Health Intervention

    Participants will receive access to the mobile health intervention. This includes access to an online dashboard which includes a drink counter, ability to track the number of drinks consumed over the course of the study, ability to set drinking-related goals for oneself, and alcohol-related resources. Participants in the intervention will also receive tailored messages during drinking episodes which target contextual factors to reduce alcohol use.

    Behavioral: Mobile Health Intervention to Reduce Alcohol Use Among Young Adults

  • No intervention
    No-contact control

    Participants will receive only morning surveys and the 30-day post-test survey.

Interventions

  • BehavioralMobile Health Intervention to Reduce Alcohol Use Among Young Adults

    The mobile just-in-time adaptive intervention consists of 1) a digital participant dashboard and 2) tailored messages delivered to the participant's cellphone addressing the individual and ecological contexts of alcohol use. The web-based intervention dashboard includes: 1) a drink counter for participants to log the number and type of drinks (e.g., beer, wine, mixed drink) they consume in a drinking occasion; 2) a calendar which summarizes the number of days on which a participant has consumed alcohol and the number of drinks consumed over the study period, broken out by drink type; 3) a log where participants can set drinking-related goals and update their progress on those goals; and 4) national and local substance use resources. Participants will receive messages tailored to their drinking situation and ecological context during high-risk drinking times.

06

What researchers measure

Primary outcomes

  1. Average Satisfaction with the Intervention

    Measured using the following item, "How satisfied are you with your experience using this intervention?" with a 5-point response scale ranging from Not at All Satisfied (1) to Extremely Satisfied (5). A higher score indicates higher satisfaction with the intervention

    Time frame: Assessed 30 days after the last 4-week survey text.

  2. Average Engagement with the Intervention Measured by the DCBI Scale

    Engagement will be assessed via 8 items from the Digital Behavior Change Intervention (DCBI) Scale. The item stem "How strongly did you experience the following?" will be repeated for the following concepts: interest, intrigue, focus, inattention, distraction, enjoyment, annoyance, and pleasure. All items will be scored on a 7 point scale from Not at All (1) to Extremely (7) and an average composite score will be derived for each participant based on responses across the seven items. Scores range from 1-7, where a higher score indicates higher engagement with the intervention.

    Time frame: Assessed 30 days after the last 4-week survey text.

Secondary outcomes

  1. Number of Drinks Consumed per Drinking Episode

    Total number of drinks consumed per drinking occasion will be assessed using 1 item: "How many standard drinks did you consume yesterday?" Response options will range from less than 1 (0) to 10 or more (10). Respondents who input 10 or more drinks will be prompted to input the total number of drinks they consumed.

    Time frame: Four days per week (Thursday-Sunday) for four consecutive weeks (16 total times).

  2. Average Drinking Level per Drinking Episode

    An ordinal measure of drinking level will be calculated based on the total drinks item ("How many standard drinks did you consume yesterday?"). Moderate drinking will be defined as 0-3 drinks for women or 0-4 drinks for men, standard binge drinking will be defined as 4-7 drinks for women or 5-9 drinks for men, and high-intensity drinking will be defined as 8 or more drinks for women or 10 or more drinks for men.

    Time frame: Four days per week (Thursday-Sunday) for four consecutive weeks (16 total times).

  3. Frequency Score of Alcohol-Related Consequences Measured by BYAACQ

    Alcohol-related consequences will be measured via the 24-item Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ), which lists a variety of alcohol-related consequences and asks participants to endorse (Yes=1; No=0) if they have experienced a specific consequence in the past month. Scores range from 0-24, where a higher score indicates a higher number of alcohol-related consequences experienced.

    Time frame: Assessed 30 days after the last 4-week survey text.

07

Study locations

1 site
  • Rosenau Hall
    Chapel Hill, North Carolina 27599, United States
08

References and documents

Study documents

  • Informed consent form · Sep 11, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — The investigator will post de-identified participant data to the National Institute of Mental Health National Data Archive (NDA).

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07126613
Lead sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Sponsor
First posted
Aug 17, 2025
Start date
Sep 29, 2025
Primary completion
Jan 6, 2026
Completion
Jan 6, 2026
Last update
Jan 21, 2026

Study contacts

Melissa J Cox, PhD
principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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