Smartphone Application for University Students With Binge Drinking Behavior

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcohol Drinking, Binge Drinking

Intervention / Treatment
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* Biological: blood microsampling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Binge Drinking<br> | Biological: blood microsampling<br>* blood microsampling for the measure of Phosphatidylethanol<br>|
| Active Comparator: Binge Drinking-control<br> | Biological: blood microsampling<br>* blood microsampling for the measure of Phosphatidylethanol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol, Binge Drinking, Phosphatidylethanol, Smartphone, Health