A PPG Sensor-Based Feedback Intervention for Heavy Drinking Young Adults
NCT ID: NCT05090995
Last Updated: 2024-12-13
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-02-23
Study Completion Date
2023-06-01
Brief Summary
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Heavy alcohol use among young adults is a significant public health problem. Advances in technology may offer an innovative solution. This project will conduct the first controlled test of a feedback intervention for reducing drinking and improving health in young adults by targeting heart rate variability, resting heart rate, and sleep via biosensors and electronic diary methods.
Detailed Description
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Proposed is a study to conduct the first controlled test of a feedback intervention targeting heart rate variability, resting heart rate, and sleep for heavy-drinking young adults (N=60; ages 18-25) and will leverage the capabilities of a consumer-marketed PPG sensor/mobile app. This study will evaluate the feasibility, acceptability, and preliminary efficacy of this intervention for promoting improvements in drinking, sleep, and health.
Conditions
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Heavy Drinking
Harmful; Use, Alcohol
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Eligible subjects will be randomized into either the Assessment or Feedback group. Subjects in the assessment group will not receive personalized health feedback or advice on their health behaviors. They will wear a consumer- level PPG device daily and complete electronic diaries about bedtime behavior and sleep from the previous night for six weeks. Subjects in the feedback group will also wear a consumer-level PPG device and complete diaries each morning for six weeks. Subjects in this group will monitor their health behaviors and receive personalized feedback and advice. Subjects will also be able to receive daily information regarding their health behaviors from the PPG device application. At weeks two, four, and six subjects will will receive written reports that summarize their alcohol usage and the links made between their drinking and health outcomes from the PPG application results. Subjects will also receive advice on how to improve health behaviors.
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Study Groups
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Self-Monitoring and Feedback
The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep behaviors daily during this time. On weeks two, four, and six subjects will receive personalized health feedback based on the PPG device data and sleep diaries.
Group Type
ACTIVE_COMPARATOR
Behavioral Self-Management and Feedback
Intervention Type
BEHAVIORAL
Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, active self-monitoring of health and behavior using daily diaries, and the provision of personalized health feedback and advice.
Self-Monitoring
The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep behaviors daily during this time.
Group Type
PLACEBO_COMPARATOR
Behavioral Self-Management
Intervention Type
BEHAVIORAL
Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, and active self-monitoring of health and behavior using daily diaries.
Interventions
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Behavioral Self-Management and Feedback
Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, active self-monitoring of health and behavior using daily diaries, and the provision of personalized health feedback and advice.
Intervention Type
BEHAVIORAL
Behavioral Self-Management
Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, and active self-monitoring of health and behavior using daily diaries.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* 18-25 years of age
* Report ≥ 4 heavy drinking occasions in the past 28 days
* Report Alcohol Use Disorders Identification Test- Consumption (AUDIT-C) scores indictive of risk of drinking harm
* English Speaking
* Have a personal smartphone
* Report ≥ 4 heavy drinking occasions in the past 28 days
* Report Alcohol Use Disorders Identification Test- Consumption (AUDIT-C) scores indictive of risk of drinking harm
* English Speaking
* Have a personal smartphone
Exclusion Criteria
* Sleep Disorder History
* Night/ Rotating work shift
* Travel two or more time zones in the month prior to the study or anticipated travel two or more times during study participation
* Clinically severe AUD in past 12 months
* Currently enrolled in alcohol or sleep treatment
* Current, severe psychiatric illness
* Current DSM-V substance use disorder
* Positive urine drug screen for a substance other than marijuana
* Night/ Rotating work shift
* Travel two or more time zones in the month prior to the study or anticipated travel two or more times during study participation
* Clinically severe AUD in past 12 months
* Currently enrolled in alcohol or sleep treatment
* Current, severe psychiatric illness
* Current DSM-V substance use disorder
* Positive urine drug screen for a substance other than marijuana
Minimum Eligible Age
18 Years
Maximum Eligible Age
25 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Sponsor Role
collaborator
Yale University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Lisa Fucito, PhD
Role: PRINCIPAL_INVESTIGATOR
Associate Professor of Psychiatry; Director, Tobacco Treatment Service, Psychiatry
Locations
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Yale University
New Haven, Connecticut, United States
Site Status
Countries
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United States
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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21-002981
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2000030417
Identifier Type: -
Identifier Source: org_study_id