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Reset Challenge: Reducing High-risk Drinking for Cancer Prevention

2026年6月24日 更新者：University of Oklahoma

Feasibility and Preliminary Efficacy of a 30-Day Reset Challenge

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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

150

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • アメリカ
    • Oklahoma
      • Tulsa、Oklahoma、アメリカ、74135
        • 募集
        • University of Oklahoma Schusterman Center - Tulsa
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：30-Day Reset
Participants will take part in a 30-day alcohol abstinence challenge. For 2 weeks before, and during the challenge participants will fill out daily surveys monitoring alcohol consumption. Additionally, there will be a longer 1 and 3-month follow-up survey after the completion of the challenge.
行動：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Feasibility of intervention based on rate of accrual with eligible participant population
時間枠：From completion of the pre-screening survey to enrollment in the study. On average, no more than two weeks.
Rate of study participation among eligible population that completes the screening survey. ≥50% of eligible individuals will enroll in the study
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
時間枠：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.
Rate of completion among enrolled participants. ≥80% of enrolled participants will complete the study
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
時間枠：From the opening of the studies accrual to 12 months later.
Amount of participants recruited to the study in a 12 month period. A total of 150 participants will be recruited within 12 months
From the opening of the studies accrual to 12 months later.
Efficacy of intervention based on reported alcohol abstinence
時間枠：From 2 weeks before the participant selected challenge start date to the end of the 30-day reset challenge. Exactly 44 days.
Percentage of patients that report abstaining from alcohol throughout the duration of the study. ≥ 60% of participants will abstain from alcohol during the challenge
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
時間枠：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.
The average rate of weekly alcohol consumption reported by participants throughout the duration of the study. Rates of alcohol consumption are expected to be maintained or decrease weekly.
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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Efficacy of intervention base on alcohol abstinence self-efficacy
時間枠：From the beginning of the 30-day challenge period to the end of the 30-day challenge period. Exactly 30 days.
Self-reported confidence in the ability to abstain from alcohol, assessed using a daily rating scale (e.g., 0-10). Abstinence self-efficacy is expected to be maintained or increase over the duration of the study.
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
時間枠：From the beginning of the 30-day challenge period to the end of the 30-day challenge period. Exactly 30 days.
Rate of self-reported alcohol consumption (weekly quantity) in daily survey. It is expected that rates of consumption will be maintained or decrease throughout the challenge period.
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
時間枠：From completion of the 30-day challenge period to 3 months post-completion of the 30-day challenge period. Exactly 3 months.
Rate of self-reported alcohol use (weekly quantity) after completion of 30 day challenge period. It is expected that rates will be maintained or continue to decrease after the 30 day challenge period
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
時間枠：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.
Reported score of alcohol abstinence self-efficacy given on survey scale (e.g., 1-10) after the challenge period. It is expected that self-efficacy scoring will be maintained or increase after complete of the 30 day challenge period.
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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Oklahoma

協力者

Presbyterian Health Foundation

捜査官

  • 主任研究者：Sophia You, PhD, ABPP、University of Oklahoma

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月10日

一次修了 (推定)

2027年12月1日

研究の完了 (推定)

2028年4月1日

試験登録日

最初に提出

2026年4月28日

QC基準を満たした最初の提出物

2026年5月12日

最初の投稿 (実際)

2026年5月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月26日

QC基準を満たした最後の更新が送信されました

2026年6月24日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 19340P

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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