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Reset Challenge: Reducing High-risk Drinking for Cancer Prevention

24 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

150

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • États-Unis
    • Oklahoma
      • Tulsa, Oklahoma, États-Unis, 74135
        • Recrutement
        • University of Oklahoma Schusterman Center - Tulsa
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Feasibility of intervention based on rate of accrual with eligible participant population
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Efficacy of intervention base on alcohol abstinence self-efficacy
Délai: 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
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Oklahoma

Collaborateurs

Presbyterian Health Foundation

Les enquêteurs

  • Chercheur principal: Sophia You, PhD, ABPP, University of Oklahoma

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 juin 2026

Achèvement primaire (Estimé)

1 décembre 2027

Achèvement de l'étude (Estimé)

1 avril 2028

Dates d'inscription aux études

Première soumission

28 avril 2026

Première soumission répondant aux critères de contrôle qualité

12 mai 2026

Première publication (Réel)

15 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 19340P

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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