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Идёт набор NCT07591428

Reset Challenge: Reducing High-risk Drinking for Cancer Prevention

Без фазы С лечением Alcohol Drinking Heavy 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: 30-Day Alcohol Abstinence Challenge.
Кому может быть актуально
Состояния в реестре: Alcohol Drinking, Heavy Drinking, Binge Drinking. Базовые параметры: 18 лет — 120 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Feasibility and Preliminary Efficacy of a 30-Day Reset Challenge

Обзор

This is a single-arm, non-randomized, prospective study to evaluate the feasibility and preliminary efficacy of a 30-day mobile Health (mHealth) Reset Challenge for reducing high-risk drinking.

Подробное описание

Alcohol is a modifiable risk factor for gastrointestinal and breast cancers, with heavy, binge, and daily drinking increasing cancer risk. To reduce these cancers, accessible, effective, and scalable alcohol interventions are needed. Mobile Health (mHealth) platforms are well suited for this purpose, as they can screen for high-risk drinking and deliver on-demand, evidence-based interventions directly to at-risk individuals. Building on the success of the 'Dry January' community intervention, the current study will develop and test a 30-day Reset Challenge. This trial will recruit 150 adults with high-risk drinking behaviors in Oklahoma and pursue three aims. First, the investigators aim to evaluate the feasibility and preliminary effectiveness of the Reset Challenge. Secondly the investigators want to evaluate whether improving confidence in alcohol cessation methods is associated with a higher likelihood of achieving 30-day abstinence. The exploratory third goal is to examine the feasibility of using an alcohol sensor as an objective outcome measure in a subsample of participants. To date, "Dry January" community interventions have only minimally investigated treatment mechanisms, and their outcomes have been assessed solely through self-reported alcohol use. Findings from the current study will determine the feasibility and preliminary efficacy of the Reset Challenge and clarify the potential role of self-efficacy as a critical predictor for successful abstinence. This work will provide foundational data for future large-scale trials aimed at reducing high-risk drinking, and ultimately lowering alcohol-related cancer in the U.S.

Вмешательства

  • Поведенческое 30-Day Alcohol Abstinence Challenge
    The 30-Day reset challenge is inspired by community intervention tools like 'Dry January'. Throughout the month long trial period, participants will be asked to abstain from alcohol consumption entirely.

Первичные конечные точки

  • Feasibility of intervention based on rate of accrual with eligible participant population [Срок оценки: From completion of the pre-screening survey to enrollment in the study. On average, no more than two weeks.]
  • Feasibility of intervention based on rate of completion amongst enrolled participants [Срок оценки: From enrollment to 3 months after the completion of the 30-Day Reset Challenge. On average, about four months, depending on the participant's selected start date.]
  • Feasibility of intervention based on efficient accrual [Срок оценки: From the opening of the studies accrual to 12 months later.]
  • Efficacy of intervention based on reported alcohol abstinence [Срок оценки: From 2 weeks before the participant selected challenge start date to the end of the 30-day reset challenge. Exactly 44 days.]
  • Efficacy of intervention based on the weekly alcohol consumption of participants [Срок оценки: From the time the participant completes the baseline survey to the completion of the 30-day challenge period. On average, about two months, depending on the participant's selected start date.]
Вторичные конечные точки (4)
  • Efficacy of intervention base on alcohol abstinence self-efficacy [Срок оценки: From the beginning of the 30-day challenge period to the end of the 30-day challenge period. Exactly 30 days.]
  • Efficacy of intervention based on reported alcohol use [Срок оценки: From the beginning of the 30-day challenge period to the end of the 30-day challenge period. Exactly 30 days.]
  • Efficacy of intervention based on sustained abstinence [Срок оценки: From completion of the 30-day challenge period to 3 months post-completion of the 30-day challenge period. Exactly 3 months.]
  • Efficacy of intervention based on sustained alcohol abstinence self-efficacy [Срок оценки: From the completion of the baseline survey to 3 months after the completion of the 30-day challenge period. On average, about 4 months, depending on the participant's selected start date.]

Критерии участия

Критерии включения

  • Adults +18
  • Individuals who drink alcohol regularly
  • Further inclusion criteria will be determined via a Zoom screening with a member of the research staff.
  • Current Oklahoma Resident

Критерии исключения

\- Exclusion criteria will be determined via a Zoom screening with a member of the research staff.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Oklahoma Schusterman Center - Tulsa — Tulsa

Идентификаторы

NCT: NCT07591428 · 19340P

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗