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Recruiting NCT06084832

Smartphone Application for University Students With Binge Drinking Behavior

No phase Interventional Alcohol Drinking Binge Drinking

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: blood microsampling.
Who it may be relevant to
Registry conditions: Alcohol Drinking, Binge Drinking. Basic parameters: 18 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Biological blood microsampling
    blood microsampling for the measure of Phosphatidylethanol

Primary outcome measures

  • Change of the number of standard drinks per week [Time frame: 30 months]
Secondary outcome measures (10)
  • Change of the PEth concentration [Time frame: 3 months]
  • Change of the PEth concentration [Time frame: 6 months]
  • Change of the PEth concentration [Time frame: 9 months]
  • Change of the PEth concentration [Time frame: 12 months]
  • Change of the PEth concentration [Time frame: 15 months]
  • Change of the PEth concentration [Time frame: 18 months]
  • Change of the PEth concentration [Time frame: 21 months]
  • Change of the PEth concentration [Time frame: 24 months]
  • Change of the PEth concentration [Time frame: 27 months]
  • Change of the PEth concentration [Time frame: 30 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

France · 1 center
  • CHU Amiens Picardie — Amiens

Publications

  • Andre C, Sauton P, Dreinaza M, Diouf M, Bodeau S, Martinetti M, Trouillet R, de Groote C, Nandrino JL, Alexandre A, Benzerouk F, Gierski F, Perney P, Grellet L, Andre J, Naassila M. Effect of the MyDefi Smartphone Application on Binge Drinking Among University Students: Protocol of a Double-Blind Multicenter Prospective National Randomized Controlled Trial Using Phosphatidylethanol as a Biomarker- PMID 40165584

Identifiers

NCT: NCT06084832 · PI2023_843_0069

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗