Reset Challenge: Reducing High-risk Drinking for Cancer Prevention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 30-Day Alcohol Abstinence Challenge.
- Who it may be relevant to
- Registry conditions: Alcohol Drinking, Heavy Drinking, Binge Drinking. Basic parameters: 18 years — 120 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Feasibility and Preliminary Efficacy of a 30-Day Reset Challenge
Overview
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.
Detailed description
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.
Interventions
- Behavioral 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.
Primary outcome measures
- Feasibility of intervention based on rate of accrual with eligible participant population [Time frame: 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 [Time frame: 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 [Time frame: From the opening of the studies accrual to 12 months later.]
- Efficacy of intervention based on reported alcohol abstinence [Time frame: 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 [Time frame: 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.]
Secondary outcome measures (4)
- Efficacy of intervention base on alcohol abstinence self-efficacy [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Oklahoma Schusterman Center - Tulsa — Tulsa
Identifiers
NCT: NCT07591428 · 19340P