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Идёт набор NCT06084832

Smartphone Application for University Students With Binge Drinking Behavior

Без фазы С лечением Alcohol Drinking Binge Drinking

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: blood microsampling.
Кому может быть актуально
Состояния в реестре: Alcohol Drinking, Binge Drinking. Базовые параметры: 18 лет — 25 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Биопрепарат blood microsampling
    blood microsampling for the measure of Phosphatidylethanol

Первичные конечные точки

  • Change of the number of standard drinks per week [Срок оценки: 30 months]
Вторичные конечные точки (10)
  • Change of the PEth concentration [Срок оценки: 3 months]
  • Change of the PEth concentration [Срок оценки: 6 months]
  • Change of the PEth concentration [Срок оценки: 9 months]
  • Change of the PEth concentration [Срок оценки: 12 months]
  • Change of the PEth concentration [Срок оценки: 15 months]
  • Change of the PEth concentration [Срок оценки: 18 months]
  • Change of the PEth concentration [Срок оценки: 21 months]
  • Change of the PEth concentration [Срок оценки: 24 months]
  • Change of the PEth concentration [Срок оценки: 27 months]
  • Change of the PEth concentration [Срок оценки: 30 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Профилактика

Центры проведения

Франция · 1 центр
  • CHU Amiens Picardie — Amiens

Публикации

  • 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

Идентификаторы

NCT: NCT06084832 · PI2023_843_0069

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗