Reset Challenge: Reducing High-risk Drinking for Cancer Prevention
24. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
150
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Sophia You, PhD, ABPP
- Telefonnummer: 918-660-3923
- E-post: Dokyoung-You@ou.edu
Studer Kontakt Backup
- Navn: Jordan Keast, BS
- E-post: jordan-keast@ou.edu
Studiesteder
-
-
Oklahoma
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Tulsa, Oklahoma, Forente stater, 74135
- Rekruttering
- University of Oklahoma Schusterman Center - Tulsa
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Ta kontakt med:
- Jordan Keast, BS
- E-post: jordan-keast@ou.edu
-
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility of intervention based on rate of accrual with eligible participant population
Tidsramme: From completion of the pre-screening survey to enrollment in the study. On average, no more than two weeks.
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Rate of study participation among eligible population that completes the screening survey.
≥50% of eligible individuals will enroll in the study
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From completion of the pre-screening survey to enrollment in the study. On average, no more than two weeks.
|
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Feasibility of intervention based on rate of completion amongst enrolled participants
Tidsramme: 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.
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Rate of completion among enrolled participants.
≥80% of enrolled participants will complete the study
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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.
|
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Feasibility of intervention based on efficient accrual
Tidsramme: From the opening of the studies accrual to 12 months later.
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Amount of participants recruited to the study in a 12 month period.
A total of 150 participants will be recruited within 12 months
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From the opening of the studies accrual to 12 months later.
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Efficacy of intervention based on reported alcohol abstinence
Tidsramme: From 2 weeks before the participant selected challenge start date to the end of the 30-day reset challenge. Exactly 44 days.
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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.
|
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Efficacy of intervention based on the weekly alcohol consumption of participants
Tidsramme: 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.
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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.
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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.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Efficacy of intervention base on alcohol abstinence self-efficacy
Tidsramme: 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.
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From the beginning of the 30-day challenge period to the end of the 30-day challenge period. Exactly 30 days.
|
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Efficacy of intervention based on reported alcohol use
Tidsramme: 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.
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From the beginning of the 30-day challenge period to the end of the 30-day challenge period. Exactly 30 days.
|
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Efficacy of intervention based on sustained abstinence
Tidsramme: 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.
|
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Efficacy of intervention based on sustained alcohol abstinence self-efficacy
Tidsramme: 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.
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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.
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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.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Sophia You, PhD, ABPP, University of Oklahoma
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
10. juni 2026
Primær fullføring (Antatt)
1. desember 2027
Studiet fullført (Antatt)
1. april 2028
Datoer for studieregistrering
Først innsendt
28. april 2026
Først innsendt som oppfylte QC-kriteriene
12. mai 2026
Først lagt ut (Faktiske)
15. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 19340P
Plan for individuelle deltakerdata (IPD)
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NEI
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