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

Not Applicable

Completed

• Conditions: Heavy Drinking; Harmful; Use, Alcohol
• Interventions: Behavioral: Behavioral Self-Management and Feedback; Behavioral: Behavioral Self-Management

• Registration Number: NCT05090995
• Lead Sponsor: Yale University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-10-11
• Study First Posted: 2021-10-25
• Study Start: 2022-02-23
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Results First Submitted: 2024-05-30
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Results First Posted: 2024-12-13
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-Monitoring and Feedback	Behavioral Self-Management 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.
Self-Monitoring	Behavioral Self-Management	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.

Primary Outcome Measures

Name	Time	Method
Total Drinks Consumed	up to Week 10	Total drinks consumed will be measured using the Time Line Followback Interview at baseline, Week 6, and Week 10. This standardized interview asks subjects to self-report how many drinks they consume each day over the past 4 weeks at baseline and then since the last assessment point at Weeks 6 and 10. Higher scores indicate a greater number of drinks consumed. Total drinks will be summed over the past 4 weeks at intake, Week 6, and Week 10. Totals were transformed using a square root transformation since these values were not normally distributed. Mixed effects models were then conducted to evaluate the effect of condition on total drinks over time with condition, time, and their interaction in the model and sex and baseline total drinks as covariates.

Secondary Outcome Measures

Name	Time	Method
Drinks Per Drinking Day	up to 10 weeks	Total drinks per drinking day will be measured using the Time Line Followback Interview at baseline, Week 6, and Week 10. Total drinks/drinking day will be summed over the past 4 weeks at intake, Week 6, and Week 10. Totals were transformed using a square root transformation since these values were not normally distributed. Mixed effects models were then conducted to evaluate the effect of condition on total drinks/drinking day over time with condition, time, and their interaction in the model and sex and baseline drinks per drinking day as covariates.; 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.
Percent Heavy Drinking Days	up to 10 weeks	Self-reported percent heavy drinking days will be measured using the Time Line Followback Interview at baseline, Week 6, and Week 10. This standardized interview asks subjects to self-report heavy drinking occasions over the past 4 weeks at baseline and then since the last assessment point at Weeks 6 and 10, defined as ≥5 drinks per sitting and for a women it would be ≥4 drinks per sitting. Higher scores indicate a greater percentage of heavy drinking days. The percentage of heavy drinking days will be summed over the past 4 weeks at intake, Week 6, and Week 10. Mixed effects models were then conducted to evaluate the effect of condition on percent heavy drinking days over time with condition, time, and their interaction in the model and sex and baseline percent heavy drinking days as covariates.
Percent Abstinent Days	up to 10 weeks	Self-reported percent abstinent days will be measured using the Time Line Followback Interview at baseline, Week 6, and Week 10. This standardized interview asks subjects to self-report how many days they did not consume any alcohol each day over the past 4 weeks at baseline and then since the last assessment point at Weeks 6 and 10. Higher scores indicate a greater percentage of abstinent days. The percentage of abstinent days will be summed over the past 4 weeks at intake, Week 6, and Week 10. Mixed effects models were then conducted to evaluate the effect of condition on percent abstinent days over time with condition, time, and their interaction in the model and sex and baseline percent abstinent days as covariates.
Alcohol-related Consequences	baseline, Week 6, and Week 10	Mean alcohol related consequences were measured using the Brief Young Adult Alcohol Consequences Questionnaire at baseline, Week 6, and Week 10. Each consequence is scored 1 point and a total score reflects the total number of consequences. Higher scores indicated more consequences.Total score range 0-24. The three timepoints are summed then averaged. Mixed effects models were then conducted to evaluate the effect of condition on consequences over time with condition, time, and their interaction in the model and sex and baseline consequences as covariates.
Sleep Quality	baseline and Week 10	Mean sleep quality will be measured using the PROMIS - Sleep Disturbance Form 8 assessment. The sleep disturbance assessment has 8 questions that yield a total score (summed scores). This raw score is then converted to a standardized T score from 0-100 with a mean score of 50. A score above the mean would indicate that the subject experiences worse sleep quality. Mixed effects models were then conducted to evaluate the effect of condition on sleep quality over time with condition, time, and their interaction in the model and sex and baseline sleep quality as covariates.
Sleep-related Impairment	baseline and Week 10	Mean sleep quality will be measured using the PROMIS - Sleep-Related Impairment Form 8 assessment. The sleep impairment assessment has 8 questions that yield a total score (summed score). This raw score is then converted to a standardized T score from 0-100 with a mean score of 50. A score above the mean would indicate that the subject experiences more sleep-related impairment. Mixed effects models were then conducted to evaluate the effect of condition on sleep-related impairment over time with condition, time, and their interaction in the model and sex and baseline sleep-related impairment as covariates.
Sleep Duration	up to 6 weeks	Mean sleep duration will be measured daily for 6 weeks by the PPG device. Sleep duration will then be averaged in 2-week intervals at Weeks 2, 4, and 6 and evaluated over time using mixed effects models with condition, time, and their interaction in the model and sex and an indicator variable of weekday vs. weekend as covariates. Sleep duration was transformed using a square-root transformation.
Heart Rate Variability (HRV)	up to 6 weeks	Heart rate variability (HRV) will be measured daily for 6 weeks by the PPG device. HRV will then be averaged in 2-week intervals at Weeks 2, 4, and 6 and evaluated over time using mixed effects models with condition, time, and their interaction in the model and sex and an indicator variable of weekday vs. weekend as covariates. Sleep duration was transformed using a log transformation.
Lowest Resting Heart Rate (RHR)	up to 6 weeks	Lowest Resting Heart Rate (RHR) will be measured daily for 6 weeks by the PPG device. The lowest value will then be averaged in 2-week intervals at Weeks 2, 4, and 6 and evaluated over time using mixed effects models with condition, time, and their interaction in the model and sex and an indicator variable of weekday vs. weekend as covariates. Sleep duration was transformed using a log transformation. RHR can vary anywhere between 40-100 beats per minute. Lower RHR would indicate better cardiovascular health.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States