A PPG Sensor-Based Feedback Intervention for Heavy Drinking Young Adults

Study Overview
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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.

Official Title
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A Photoplethysmography Sensor-based Personalized Feedback Intervention for Heavy-drinking Young Adults Targeting Heart Rate Variability, Resting Heart Rate, and Sleep

Conditions
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Heavy Drinking, Harmful; Use, Alcohol

Intervention / Treatment
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* Behavioral: Behavioral Self-Management and Feedback
* Behavioral: Behavioral Self-Management


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self-Monitoring and Feedback<br>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. | Behavioral: Behavioral Self-Management and Feedback<br>* 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.<br>|
| Placebo Comparator: Self-Monitoring<br>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. | Behavioral: Behavioral Self-Management<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total drinks consumed | Total drinks consumed will be measured using the Time Line Feedback Assessment. This tools asks subjects to self-report how many drinks they consume during a one month period. The score of this tool is dependent upon the amount of drinks consumed by the subject. Higher scores indicate more alcohol consumption for the given month. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drinks per drinking day | Total drinks per drinking day will be measured using the Time Line Feedback Assessment. This tools asks subjects to self-report how many drinks they consume during a one month period. The score of this measure will be determined by the amount of self-reported alcohol consumption that occurred each day. A heavy drinking day for a man would be ≥5 drinks per sitting and for a women it would be ≥4 drinks per sitting. | 10 weeks | 
| Percent heavy drinking days | Percent of heavy drinking days will be measured using the Time Line Feedback Assessment. This tools asks subjects to self-report how many drinks they consume during a one month period. The score of this measure will be determined by the amount of heavy drinking days that occurred in the given month, for a man this would be ≥5 drinks per sitting and for a women it would be ≥4 drinks per sitting. A higher percentage in this category would indicate that there were more heavy drinking days for the subject this month. | 10 weeks | 
| Self-reported abstinent days | Self-reported abstinent days will be measured using the Time Line Feedback Assessment. This tools asks subjects to self-report how many drinks they consume during a one month period. The score of this measure will be determined by how many days a subject abstains from drinking. A higher score in this area would indicate less drinking days for the subject this month. | 10 weeks | 
| Alcohol-related consequences | Alcohol related positive consequences will be measured using the PROMIS Alcohol- negative consequences assessment and the PROMIS Alcohol- positive consequences assessment. The negative consequences assessment has 31 questions and the positive consequences assessment has 20 questions. The range for this standardized measure is 0-100 with a mean score of 50. A score above the mean would indicate that the subject experiences more alcohol-related consequences. | 10 weeks | 
| Sleep quality | Sleep quality will be measured using the PROMIS Sleep- Related Impairment and Sleep Disturbance assessments. The sleep disturbance assessment has 27 questions and sleep related impairment assessment has 16 questions. The range for this standardized measure is 0-100 with a mean score of 50. A score above the mean would indicate that the subject experiences worse sleep quality. | 10 weeks | 
| Sleep-related impairment | Sleep-related impairment will be measured using the PROMIS Sleep- Related Impairment and Sleep Disturbance assessments. The sleep disturbance assessment has 27 questions and the sleep-related impairment assessment has 16 questions. The range for this standardized measure is 0-100 with a mean score of 50. A score above the mean would indicate that the subject experiences more sleep-related impairments. | 10 weeks | 
| Sleep Duration | Sleep duration will be measured using data from the PPG device.This tool will measure how long a subject slept each night. Ideally, 7-9 hours of sleep should be obtained per night by young adults and this measure will allow subjects to see if they fall above or below the ideal. | 6 weeks | 
| Heart Rate Variability (HRV) | Heart rate variability (HRV) will be measured using the PPG Device's HRV daily data. This tool monitors subjects heart rate, HRV can range from person to person, but typically higher HRV would indicate better cardiovascular health. | 6 weeks | 
| Resting Heart Rate (RHR) | Resting Heart Rate (RHR) will be measured using the PPG Device's RHR daily data. This tool monitors subjects heart rate, RHR can vary anywhere between 40-100 beats per minute. Lower RHR would indicate better cardiovascular health. | 6 weeks |