Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Reset Challenge: Reducing High-risk Drinking for Cancer Prevention

24 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

150

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Estados Unidos
    • Oklahoma
      • Tulsa, Oklahoma, Estados Unidos, 74135
        • Recrutamento
        • University of Oklahoma Schusterman Center - Tulsa
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Feasibility of intervention based on rate of accrual with eligible participant population
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Efficacy of intervention base on alcohol abstinence self-efficacy
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Oklahoma

Colaboradores

Presbyterian Health Foundation

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

10 de junho de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2027

Conclusão do estudo (Estimado)

1 de abril de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

28 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de maio de 2026

Primeira postagem (Real)

15 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 19340P

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever