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

Primary Purpose

Alcohol Drinking, Binge Drinking

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood microsampling
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking focused on measuring Alcohol, Binge Drinking, Phosphatidylethanol, Smartphone, Health

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens PicardieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Binge Drinking

Binge Drinking-control

Arm Description

Outcomes

Primary Outcome Measures

Change of the number of standard drinks per week

Secondary Outcome Measures

Change of the PEth concentration
phosphatidylethanol (PEth)
Change of the PEth concentration
phosphatidylethanol (PEth)
Change of the PEth concentration
phosphatidylethanol (PEth)
Change of the PEth concentration
phosphatidylethanol (PEth)
Change of the PEth concentration
phosphatidylethanol (PEth)
Change of the PEth concentration
phosphatidylethanol (PEth)
Change of the PEth concentration
phosphatidylethanol (PEth)
Change of the PEth concentration
phosphatidylethanol (PEth)
Change of the PEth concentration
phosphatidylethanol (PEth)
Change of the PEth concentration
phosphatidylethanol (PEth)

Full Information

First Posted
October 10, 2023
Last Updated
October 17, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
EPSM Marne, Reims, SCA-LAB UMR-CNRS 9193, Lille, Paul Valery University, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT06084832
Brief Title
Smartphone Application for University Students With Binge Drinking Behavior
Acronym
SmartBinge
Official Title
Smartphone Application for University Students With Binge Drinking Behavior: National Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Actual)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
EPSM Marne, Reims, SCA-LAB UMR-CNRS 9193, Lille, Paul Valery University, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Binge Drinking
Keywords
Alcohol, Binge Drinking, Phosphatidylethanol, Smartphone, Health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Non-Randomized
Enrollment
628 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Binge Drinking
Arm Type
Experimental
Arm Title
Binge Drinking-control
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
blood microsampling
Intervention Description
blood microsampling for the measure of Phosphatidylethanol
Primary Outcome Measure Information:
Title
Change of the number of standard drinks per week
Time Frame
30 months
Secondary Outcome Measure Information:
Title
Change of the PEth concentration
Description
phosphatidylethanol (PEth)
Time Frame
3 months
Title
Change of the PEth concentration
Description
phosphatidylethanol (PEth)
Time Frame
6 months
Title
Change of the PEth concentration
Description
phosphatidylethanol (PEth)
Time Frame
9 months
Title
Change of the PEth concentration
Description
phosphatidylethanol (PEth)
Time Frame
12 months
Title
Change of the PEth concentration
Description
phosphatidylethanol (PEth)
Time Frame
15 months
Title
Change of the PEth concentration
Description
phosphatidylethanol (PEth)
Time Frame
18 months
Title
Change of the PEth concentration
Description
phosphatidylethanol (PEth)
Time Frame
21 months
Title
Change of the PEth concentration
Description
phosphatidylethanol (PEth)
Time Frame
24 months
Title
Change of the PEth concentration
Description
phosphatidylethanol (PEth)
Time Frame
27 months
Title
Change of the PEth concentration
Description
phosphatidylethanol (PEth)
Time Frame
30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mickael Naasila, Pr
Phone
03.22.82.76.72
Email
mickael.naassila@u-picardie.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Bodeau, Dr
Phone
03.22.08.70.34
Email
bodeau.sandra@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra BODEAU, Dr
Phone
+33322087029
Email
bodeau.sandra@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Mickael Naasila, Pr
Phone
03.22.82.76.72
Email
mickael.naassila@u-picardie.fr
First Name & Middle Initial & Last Name & Degree
Pierre SAUTON
First Name & Middle Initial & Last Name & Degree
Farid BENZEROUK, DR
First Name & Middle Initial & Last Name & Degree
Jean-Louis NANDRINO, Dr
First Name & Middle Initial & Last Name & Degree
Raphaël TROUILLET, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Smartphone Application for University Students With Binge Drinking Behavior

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