Clinical trial NCT06084832: Smartphone Application for University Students With Binge Drinking Behavior
Official title: Smartphone Application for University Students With Binge Drinking Behavior: National Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Drinking
Binge Drinking
Keywords: Alcohol
Binge Drinking
Phosphatidylethanol
Smartphone
Health
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: EPSM Marne, Reims
name: SCA-LAB UMR-CNRS 9193, Lille
name: Paul Valery University, Montpellier
First posted: 2023-10-16
Enrollment: 628
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change of the number of standard drinks per week
timeFrame: 30 months
Secondary outcomes:
measure: Change of the PEth concentration
timeFrame: 3 months
measure: Change of the PEth concentration
timeFrame: 6 months
measure: Change of the PEth concentration
timeFrame: 9 months
measure: Change of the PEth concentration
timeFrame: 12 months
measure: Change of the PEth concentration
timeFrame: 15 months
measure: Change of the PEth concentration
timeFrame: 18 months
measure: Change of the PEth concentration
timeFrame: 21 months
measure: Change of the PEth concentration
timeFrame: 24 months
measure: Change of the PEth concentration
timeFrame: 27 months
measure: Change of the PEth concentration
timeFrame: 30 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References: