- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06326099
Brief Binge Eating and Drinking Online Intervention
March 15, 2024 updated by: Eric Pedersen, University of Southern California
A Mobile-Based Intervention to Address Heavy Drinking and Binge Eating in College Students
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Despite the prevalence of binge drinking and binge eating behaviors among college students, few students seek care for either.
Intervening with college students early is essential as untreated symptoms of binge drinking and binge eating behaviors can become more severe and persistent over time, often leading to diagnosed disorders and lasting consequences on students' social functioning, physical health, and educational attainment.
Thus, the major goal of this research study is to target 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, as well as encourage students to seek more formal in-person counseling.
The intervention combines two innovations to facilitate behavior change: (1) personalized drinking and binge eating intervention content with harm reduction and cognitive behavioral skills proven to be efficacious in reducing these problematic behaviors among college students delivered via (2) a mobile-based program that increases accessibility, is easy and engaging to use, and broadens the accessibility of the intervention content to an often non-treatment seeking group.
The intervention is informed by evidence-based practices, with student and expert feedback, to help limit alcohol consumption, engage in healthier eating behaviors, and practice alternate strategies to manage negative affect.
Study Type
Interventional
Enrollment (Estimated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eric Pedersen, Ph.D.
- Phone Number: 323-442-4046
- Email: Eric.Pedersen@med.usc.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- not meeting eligibility criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brief Online Binge Eating and Drinking Intervention
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.
|
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.
Other Names:
|
No Intervention: Resources Only
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of past 28-day binge drinking
Time Frame: Baseline, one-month follow-up, and three-month follow-up
|
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
Time Frame: Baseline, one-month follow-up, and three-month follow-up
|
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)
Time Frame: Baseline, one-month follow-up, and three-month follow-up
|
21 alcohol-related consequences experienced in the past month
|
Baseline, one-month follow-up, and three-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental Health/Substance Use Disorder Treatment History Inventory
Time Frame: Baseline, one-month follow-up, and three-month follow-up
|
Utilization of mental health and/or substance use care
|
Baseline, one-month follow-up, and three-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2024
Primary Completion (Estimated)
April 30, 2026
Study Completion (Estimated)
April 30, 2026
Study Registration Dates
First Submitted
March 15, 2024
First Submitted That Met QC Criteria
March 15, 2024
First Posted (Actual)
March 22, 2024
Study Record Updates
Last Update Posted (Actual)
March 22, 2024
Last Update Submitted That Met QC Criteria
March 15, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34AA030655 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
Within one year of the main effects paper being submitted for publication
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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