Reset Challenge: Reducing High-risk Drinking for Cancer Prevention

NCT07591428 | Recruiting DMC

• 1 other identifier: 19340P
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Heavy Drinking; Binge Drinking; Alcohol Drinking

Keywords

Daily drinking; Binge or Heavy Drinking; Dry January; Abstinence Challenge; 30-day break

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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

  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.

Secondary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (1)

30-Day Reset

EXPERIMENTAL

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.

Behavioral: 30-Day Alcohol Abstinence Challenge

Interventions

30-Day Alcohol Abstinence Challenge BEHAVIORAL

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.

30-Day Reset

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults +18
• Individuals who drink alcohol regularly

Sponsors & Collaborators

• University of Oklahoma: lead
• Presbyterian Health Foundation: collaborator

Study Sites (1)

University of Oklahoma Schusterman Center - Tulsa

Tulsa, Oklahoma, 74135, United States

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking; Binge Drinking; Binge-Eating Disorder

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Feeding and Eating Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Sophia You, PhD, ABPP

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophia You, PhD, ABPP

CONTACT

918-660-3923; Dokyoung-You@ou.edu

Jordan Keast, BS

CONTACT

jordan-keast@ou.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 15, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)