Reset Challenge: Reducing High-risk Drinking for Cancer Prevention
24 czerwca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Rekrutacyjny
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
150
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Sophia You, PhD, ABPP
- Numer telefonu: 918-660-3923
- E-mail: Dokyoung-You@ou.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Jordan Keast, BS
- E-mail: jordan-keast@ou.edu
Lokalizacje studiów
-
-
Oklahoma
-
Tulsa, Oklahoma, Stany Zjednoczone, 74135
- Rekrutacyjny
- University of Oklahoma Schusterman Center - Tulsa
-
Kontakt:
- Jordan Keast, BS
- E-mail: jordan-keast@ou.edu
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Feasibility of intervention based on rate of accrual with eligible participant population
Ramy czasowe: 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
|
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
Ramy czasowe: 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
|
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
Ramy czasowe: 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
|
From the opening of the studies accrual to 12 months later.
|
|
Efficacy of intervention based on reported alcohol abstinence
Ramy czasowe: 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
|
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
Ramy czasowe: 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.
|
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.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Efficacy of intervention base on alcohol abstinence self-efficacy
Ramy czasowe: 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.
|
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
Ramy czasowe: 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.
|
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
Ramy czasowe: 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.
|
|
Efficacy of intervention based on sustained alcohol abstinence self-efficacy
Ramy czasowe: 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.
|
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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Sophia You, PhD, ABPP, University of Oklahoma
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
10 czerwca 2026
Zakończenie podstawowe (Szacowany)
1 grudnia 2027
Ukończenie studiów (Szacowany)
1 kwietnia 2028
Daty rejestracji na studia
Pierwszy przesłany
28 kwietnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
12 maja 2026
Pierwszy wysłany (Rzeczywisty)
15 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
26 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
24 czerwca 2026
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 19340P
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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