Alcohol Drinking, Binge Drinking, Heavy Drinking
Conditions
Keywords
Daily drinking, Binge or Heavy Drinking, Dry January, Abstinence Challenge, 30-day break
Brief summary
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
BEHAVIORAL30-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.
Sponsors
University of Oklahoma
Presbyterian Health Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of intervention based on rate of accrual with eligible participant population | 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 |
| Feasibility of intervention based on rate of completion amongst enrolled participants | 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 |
| Feasibility of intervention based on efficient accrual | 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 |
| Efficacy of intervention based on reported alcohol abstinence | 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 |
| Efficacy of intervention based on the weekly alcohol consumption of participants | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of intervention base on alcohol abstinence self-efficacy | 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. |
| Efficacy of intervention based on reported alcohol use | 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. |
| Efficacy of intervention based on sustained abstinence | 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 |
| Efficacy of intervention based on sustained alcohol abstinence self-efficacy | 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. |
Countries
United States
Contacts
CONTACTSophia You, PhD, ABPP
CONTACTJordan Keast, BS
PRINCIPAL_INVESTIGATORSophia You, PhD, ABPP
University of Oklahoma
Outcome results
None listed