Reset Challenge: Reducing High-risk Drinking for Cancer Prevention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-120
SponsorUniversity of Oklahoma
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
30-Day Alcohol Abstinence Challenge
BehavioralThe 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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: 30-Day ResetExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of intervention based on rate of accrual with eligible participant population
Rate of study participation among eligible population that completes the screening survey. ≥50% of eligible individuals will enroll in the study
Time frame
From completion of the pre-screening survey to enrollment in the study. On average, no more than two weeks.2
Feasibility of intervention based on rate of completion amongst enrolled participants
Rate of completion among enrolled participants. ≥80% of enrolled participants will complete the study
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.3
Feasibility of intervention based on efficient accrual
Amount of participants recruited to the study in a 12 month period. A total of 150 participants will be recruited within 12 months
Time frame
From the opening of the studies accrual to 12 months later.4
Efficacy of intervention based on reported alcohol abstinence
Percentage of patients that report abstaining from alcohol throughout the duration of the study. ≥ 60% of participants will abstain from alcohol during the challenge
Time frame
From 2 weeks before the participant selected challenge start date to the end of the 30-day reset challenge. Exactly 44 days.Secondary outcomes
1
Efficacy of intervention base on alcohol abstinence self-efficacy
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.
Time frame
From the beginning of the 30-day challenge period to the end of the 30-day challenge period. Exactly 30 days.2
Efficacy of intervention based on reported alcohol use
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.
Time frame
From the beginning of the 30-day challenge period to the end of the 30-day challenge period. Exactly 30 days.3
Efficacy of intervention based on sustained abstinence
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
Time frame
From completion of the 30-day challenge period to 3 months post-completion of the 30-day challenge period. Exactly 3 months.4
Efficacy of intervention based on sustained alcohol abstinence self-efficacy
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.
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Oklahoma
Lead sponsor
Presbyterian Health Foundation
Collaborator
Source ClinicalTrials.gov