NCT06326099

Brief Summary

This pilot project targets both binge drinking and binge eating behavior in college students through a mobile-based online program that provides students with evidence-based intervention material designed to reduce the incidence of both behaviors and encourage students to seek more formal in-person counseling.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

12 months

First QC Date

March 15, 2024

Last Update Submit

March 5, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Frequency of past 28-day binge drinking

    Number of binge drinking episodes in the past 28 days

    Baseline, one-month follow-up, and three-month follow-up

  • Frequency of past 28-day binge eating

    Number of binge eating episodes in the past 28 days

    Baseline, one-month follow-up, and three-month follow-up

  • Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ)

    21 alcohol-related consequences experienced in the past month. Sum positive responses to get a score from 0 to 24 (higher score indicates greater number of consequences)

    Baseline, one-month follow-up, and three-month follow-up

Secondary Outcomes (1)

  • Mental Health/Substance Use Disorder Treatment History Inventory

    Baseline, one-month follow-up, and three-month follow-up

Study Arms (2)

Brief Online Binge Eating and Drinking Intervention

EXPERIMENTAL

The intervention is a 30 minute mobile phone program designed to address binge eating and drinking. The program addresses underlying loss of control, impulsivity, and emotion regulation common to both binge drinking and binge eating through videos, interactive activities, and psychoeducation.

Behavioral: Brief Online Binge Eating and Drinking Intervention

Resources Only

NO INTERVENTION

Campus-specific resources for how to access the university's counseling office (i.e., student mental health services), information about the Eating Disorders program at the university, and information on accessing the university's alcohol and drug awareness offices.

Interventions

The intervention is an online mobile phone program developed by our research team. It builds upon efficacious brief alcohol interventions with college students by addressing underlying loss of control, impulsivity, and emotion regulation through the use of videos, interactive activities, and psychoeducation.

Also known as: Sip n' Savor
Brief Online Binge Eating and Drinking Intervention

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • full time undergraduate student at the study site
  • between the ages of 18 and 24
  • ability to speak and read English
  • at least two occasions of binge drinking (5 or more drinks in a row for males, 4 (i.e., an objectively large amount of food with a self-reported loss of control) in the past 28 days
  • at least two occasions of binge eating (i.e., an objectively large amount of food with a self-reported loss of control)151 in the past 28 days
  • no receipt of mental health or substance use care in the past month.

You may not qualify if:

  • not meeting eligibility criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

BulimiaBinge Drinking

Condition Hierarchy (Ancestors)

HyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersAlcohol DrinkingDrinking BehaviorBehaviorMental Disorders

Central Study Contacts

Eric Pedersen, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 15, 2024

First Posted

March 22, 2024

Study Start

May 1, 2025

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

Following the NIH Data Sharing Policy and Implementation Guidelines, we plan to make the datasets available for sharing at the time that the main project findings are accepted for publication during the final year of the project.

Shared Documents
STUDY PROTOCOL
Time Frame
Within one year of the main effects paper being submitted for publication
Access Criteria
Individual researchers can contact the PIs for data and through filling out a data request and use form that we will create for the purposes of data sharing.