Harmful; Use, Alcohol, Heavy Drinking
Conditions
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.
Interventions
BEHAVIORALBehavioral 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.
BEHAVIORALBehavioral 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.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 30 |
| 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.
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. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Self-Monitoring and Feedback | Self-Monitoring | Total |
|---|---|---|---|
| Age, Continuous | 22.33 years STANDARD_DEVIATION 1.83 | 21.71 years STANDARD_DEVIATION 2.13 | 22.02 years STANDARD_DEVIATION 1.99 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 25 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gender Female | 15 Participants | 14 Participants | 29 Participants |
| Gender Male | 14 Participants | 16 Participants | 30 Participants |
| Gender Nonbinary | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 25 Participants | 24 Participants | 49 Participants |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 15 Participants | 14 Participants | 29 Participants |
| Sex: Female, Male Male | 15 Participants | 16 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Total Drinks Consumed
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.
Time frame: up to Week 10
Population: All randomized participants who started either treatment condition.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Self-Monitoring and Feedback | Total Drinks Consumed | 6.76 drinks | Standard Error 0.26 |
| Self-Monitoring | Total Drinks Consumed | 7.07 drinks | Standard Error 0.26 |
p-value: <0.0001Mixed Models Analysis
Secondary
Alcohol-related Consequences
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.
Time frame: baseline, Week 6, and Week 10
Population: All randomized participants who started either treatment condition.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Self-Monitoring and Feedback | Alcohol-related Consequences | 8.56 score on scale | Standard Error 0.75 |
| Self-Monitoring | Alcohol-related Consequences | 8.23 score on scale | Standard Error 0.76 |
Comparison: For baseline consequencesp-value: <0.0001Mixed Models Analysis
Comparison: For effects with timep-value: <0.0001Mixed Models Analysis
Secondary
Drinks Per Drinking Day
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.
Time frame: up to 10 weeks
Population: All randomized participants who started either condition.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Self-Monitoring and Feedback | Drinks Per Drinking Day | 2.26 drinks per drinking day | Standard Error 0.05 |
| Self-Monitoring | Drinks Per Drinking Day | 2.34 drinks per drinking day | Standard Error 0.05 |
p-value: <0.0001Mixed Models Analysis
Secondary
Heart Rate Variability (HRV)
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.
Time frame: up to 6 weeks
Population: All randomized participants who started either treatment condition.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Self-Monitoring and Feedback | Heart Rate Variability (HRV) | Weeks 1-2 | 7.55 milliseconds | Standard Error 0.35 |
| Self-Monitoring and Feedback | Heart Rate Variability (HRV) | Weeks 3-4 | 7.63 milliseconds | Standard Error 0.35 |
| Self-Monitoring and Feedback | Heart Rate Variability (HRV) | Weeks 5-6 | 7.68 milliseconds | Standard Error 0.35 |
| Self-Monitoring | Heart Rate Variability (HRV) | Weeks 1-2 | 7.79 milliseconds | Standard Error 0.35 |
| Self-Monitoring | Heart Rate Variability (HRV) | Weeks 3-4 | 7.81 milliseconds | Standard Error 0.35 |
| Self-Monitoring | Heart Rate Variability (HRV) | Weeks 5-6 | 7.84 milliseconds | Standard Error 0.35 |
Comparison: Main effect of day of the week.p-value: 0.0001Mixed Models Analysis
Secondary
Lowest Resting Heart Rate (RHR)
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.
Time frame: up to 6 weeks
Population: All randomized participants who started either treatment condition.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Self-Monitoring and Feedback | Lowest Resting Heart Rate (RHR) | Weeks 1-2 | 4.06 beats per minute | Standard Error 0.02 |
| Self-Monitoring and Feedback | Lowest Resting Heart Rate (RHR) | Weeks 3-4 | 4.06 beats per minute | Standard Error 0.02 |
| Self-Monitoring and Feedback | Lowest Resting Heart Rate (RHR) | Weeks 5-6 | 4.05 beats per minute | Standard Error 0.02 |
| Self-Monitoring | Lowest Resting Heart Rate (RHR) | Weeks 1-2 | 4.03 beats per minute | Standard Error 0.02 |
| Self-Monitoring | Lowest Resting Heart Rate (RHR) | Weeks 3-4 | 4.03 beats per minute | Standard Error 0.02 |
| Self-Monitoring | Lowest Resting Heart Rate (RHR) | Weeks 5-6 | 4.03 beats per minute | Standard Error 0.02 |
Comparison: For interaction between treatment condition and timep-value: 0.04Mixed Models Analysis
Comparison: Main effects of sexp-value: <0.0001Mixed Models Analysis
Comparison: Main effects of type of day of the week (weekday vs. weekend)p-value: <0.0001Mixed Models Analysis
p-value: 0.03Mixed Models Analysis
Secondary
Percent Abstinent Days
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.
Time frame: up to 10 weeks
Population: All randomized participants who started either treatment condition.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Self-Monitoring and Feedback | Percent Abstinent Days | 66.04 percentage of abstinent days | Standard Error 1.76 |
| Self-Monitoring | Percent Abstinent Days | 65.56 percentage of abstinent days | Standard Error 1.78 |
p-value: <0.0001Mixed Models Analysis
Secondary
Percent Heavy Drinking Days
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.
Time frame: up to 10 weeks
Population: All randomized participants who started either treatment condition.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Self-Monitoring and Feedback | Percent Heavy Drinking Days | 18.62 percentage of heavy drinking days | Standard Error 1.48 |
| Self-Monitoring | Percent Heavy Drinking Days | 19.83 percentage of heavy drinking days | Standard Error 1.49 |
p-value: <0.0001Mixed Models Analysis
Secondary
Sleep Duration
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.
Time frame: up to 6 weeks
Population: All randomized participants who started either condition.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Self-Monitoring and Feedback | Sleep Duration | Weeks 1-2 | 168.73 square root in milliseconds | Standard Error 1.37 |
| Self-Monitoring and Feedback | Sleep Duration | Weeks 3-4 | 172.18 square root in milliseconds | Standard Error 1.37 |
| Self-Monitoring and Feedback | Sleep Duration | Weeks 5-6 | 171.74 square root in milliseconds | Standard Error 1.37 |
| Self-Monitoring | Sleep Duration | Weeks 1-2 | 170.78 square root in milliseconds | Standard Error 1.37 |
| Self-Monitoring | Sleep Duration | Weeks 3-4 | 169.38 square root in milliseconds | Standard Error 1.38 |
| Self-Monitoring | Sleep Duration | Weeks 5-6 | 170.11 square root in milliseconds | Standard Error 1.41 |
Comparison: For interaction between treatment group and timep-value: 0.02Mixed Models Analysis
Comparison: Main effects of sexp-value: 0.02Mixed Models Analysis
Comparison: Main effects of type of day of the week (weekday vs. weekend)p-value: 0.0007Mixed Models Analysis
p-value: 0.02Mixed Models Analysis
Secondary
Sleep Quality
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.
Time frame: baseline and Week 10
Population: All randomized participants who started either condition.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Self-Monitoring and Feedback | Sleep Quality | 50.59 T-score | Standard Error 0.93 |
| Self-Monitoring | Sleep Quality | 50.38 T-score | Standard Error 0.93 |
p-value: <0.0001Mixed Models Analysis
Secondary
Sleep-related Impairment
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.
Time frame: baseline and Week 10
Population: All randomized participants who started either condition.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Self-Monitoring and Feedback | Sleep-related Impairment | 53.98 T-score | Standard Error 1.1 |
| Self-Monitoring | Sleep-related Impairment | 55.05 T-score | Standard Error 1.11 |
Comparison: Effect of baseline sleep scoresp-value: <0.0001Mixed Models Analysis
Comparison: For effects with timep-value: 0.04Mixed Models Analysis