Reset Challenge: Reducing High-risk Drinking for Cancer Prevention
24 de junio de 2026 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
150
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Sophia You, PhD, ABPP
- Número de teléfono: 918-660-3923
- Correo electrónico: Dokyoung-You@ou.edu
Copia de seguridad de contactos de estudio
- Nombre: Jordan Keast, BS
- Correo electrónico: jordan-keast@ou.edu
Ubicaciones de estudio
-
-
Oklahoma
-
Tulsa, Oklahoma, Estados Unidos, 74135
- Reclutamiento
- University of Oklahoma Schusterman Center - Tulsa
-
Contacto:
- Jordan Keast, BS
- Correo electrónico: jordan-keast@ou.edu
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Feasibility of intervention based on rate of accrual with eligible participant population
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Efficacy of intervention base on alcohol abstinence self-efficacy
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sophia You, PhD, ABPP, University of Oklahoma
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
10 de junio de 2026
Finalización primaria (Estimado)
1 de diciembre de 2027
Finalización del estudio (Estimado)
1 de abril de 2028
Fechas de registro del estudio
Enviado por primera vez
28 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de mayo de 2026
Publicado por primera vez (Actual)
15 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Desordenes mentales
- Trastornos relacionados con sustancias
- Trastornos inducidos químicamente
- Comportamiento de bebida
- Trastornos relacionados con el alcohol
- Trastornos de la alimentación y la alimentación
- Comportamiento
- Consumo de alcohol
- Trastorno por atracones
- Consumo excesivo de alcohol
- Químicos orgánicos
- Alcoholes
- Etanol
Otros números de identificación del estudio
- 19340P
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .