Smartphone Application for University Students With Binge Drinking Behavior (SmartBinge)

Smartphone Application for University Students With Binge Drinking Behavior: National Randomized Controlled Trial

Alcohol use is a causal factor in more than 200 diseases and injury conditions (see ICD-10) and in France, alcohol is the first cause of hospitalization. Binge drinking (BD) has emerged as a major public health issue among student populations and is associated with negative consequences and social, cognitive and brain alterations. More than half of French university students have reported BD in the past month and are at increased risk of several alcohol-related consequences such as memory and sleep impairments, and reduced quality of life. BD is also a major risk factor in the development of alcohol addiction, with individual and environmental factors playing a role that is still poorly understood. Moreover, most students and young adults are reluctant to seek interventions when it is provided by health care professionals (only 4-5%) and have poor insight with regard to their alcohol use patterns / habits. Thus, there is an urgent need for developing effective prevention and intervention programs to reduce alcohol drinking in students. Recent studies have demonstrated that new types of technology-delivered interventions are promising tools for addressing unhealthy alcohol use. For example, an uncontrolled trial pilot study using a smartphone application-delivered intervention produced a reduction in both number of drinks per week and BD from baseline to 3-month follow-up. A recent review also showed significant outcomes of a mobile health intervention for self-control of unhealthy alcohol use. The investigators hypothesize that a timeline follow-back and personalized feedback based on the use of a mobile application can reduce excessive alcohol intake at 3-months. This study will provide scientific knowledge about BD in students, but also regarding a new type of intervention that could be effective for prevention in non-treatment seeking individuals and reducing the severity of health problems associated with excessive alcohol intake.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Drinking; Binge Drinking
• Intervention / Treatment: Biological: blood microsampling

• Study Type: Interventional
• Enrollment (Estimated): 628
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mickael Naasila, Pr; Phone Number: 03.22.82.76.72; Email: mickael.naassila@u-picardie.fr
• Study Contact Backup: Name: Sandra Bodeau, Dr; Phone Number: 03.22.08.70.34; Email: bodeau.sandra@chu-amiens.fr

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • Recruiting
      • CHU Amiens Picardie
      • Contact: Sandra BODEAU, Dr; Phone Number: +33322087029; Email: bodeau.sandra@chu-amiens.fr
      • Contact: Mickael Naasila, Pr; Phone Number: 03.22.82.76.72; Email: mickael.naassila@u-picardie.fr
      • Sub-Investigator: Pierre SAUTON
      • Principal Investigator: Farid BENZEROUK, DR
      • Principal Investigator: Jean-Louis NANDRINO, Dr
      • Principal Investigator: Raphaël TROUILLET, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Students between 18 and 25 years old
• AUQ score greater than or equal to 24, and AUDIT score greater than or equal to 3 for its first 3 items. Drinking details with the DDQ when necessary.
• BD behavior: at least one occasion with 6 or more drinks in the last 3 months.
• Consent to be included in the study
• Affiliated to social security

Exclusion Criteria:

• Not having a smartphone with an Apple or Android system.
• Previous use of the MyDéfi smartphone application
• Declaration of a psychiatric / neurologic condition
• Pregnant, parturient or breastfeeding woman
• Subject under guardianship, curators or restricted under public law

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Binge Drinking	Biological: blood microsampling; blood microsampling for the measure of Phosphatidylethanol
Active Comparator: Binge Drinking-control	Biological: blood microsampling; blood microsampling for the measure of Phosphatidylethanol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of the number of standard drinks per week	30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the PEth concentration	phosphatidylethanol (PEth)	3 months
Change of the PEth concentration	phosphatidylethanol (PEth)	6 months
Change of the PEth concentration	phosphatidylethanol (PEth)	9 months
Change of the PEth concentration	phosphatidylethanol (PEth)	12 months
Change of the PEth concentration	phosphatidylethanol (PEth)	15 months
Change of the PEth concentration	phosphatidylethanol (PEth)	18 months
Change of the PEth concentration	phosphatidylethanol (PEth)	21 months
Change of the PEth concentration	phosphatidylethanol (PEth)	24 months
Change of the PEth concentration	phosphatidylethanol (PEth)	27 months
Change of the PEth concentration	phosphatidylethanol (PEth)	30 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: EPSM Marne, Reims; SCA-LAB UMR-CNRS 9193, Lille; Paul Valery University, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Smartphone; Health; Alcohol; Binge Drinking; Phosphatidylethanol
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcohol Drinking; Drinking Behavior; Binge Drinking
• Other Study ID Numbers: PI2023_843_0069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No