Trial Outcomes & Findings for A PPG Sensor-Based Feedback Intervention for Heavy Drinking Young Adults (NCT NCT05090995)

Last Updated: 2024-12-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

up to Week 10

Results posted on

2024-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	30	30
Overall Study Completed Week 6	30	30
Overall Study Completed Week 10	30	29
Overall Study COMPLETED	30	29
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Self-Monitoring and Feedback n=30 Participants 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.	Self-Monitoring n=30 Participants 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.	Total n=60 Participants Total of all reporting groups
Age, Continuous	22.33 years STANDARD_DEVIATION 1.83 • n=93 Participants	21.71 years STANDARD_DEVIATION 2.13 • n=4 Participants	22.02 years STANDARD_DEVIATION 1.99 • n=27 Participants
Sex: Female, Male Female	15 Participants n=93 Participants	14 Participants n=4 Participants	29 Participants n=27 Participants
Sex: Female, Male Male	15 Participants n=93 Participants	16 Participants n=4 Participants	31 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants	5 Participants n=4 Participants	9 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=93 Participants	25 Participants n=4 Participants	51 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) White	25 Participants n=93 Participants	24 Participants n=4 Participants	49 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	30 participants n=93 Participants	30 participants n=4 Participants	60 participants n=27 Participants
Gender Female	15 Participants n=93 Participants	14 Participants n=4 Participants	29 Participants n=27 Participants
Gender Male	14 Participants n=93 Participants	16 Participants n=4 Participants	30 Participants n=27 Participants
Gender Nonbinary	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants

PRIMARY outcome

Timeframe: up to Week 10

Population: All randomized participants who started either treatment condition.

Outcome measures

Outcome measures
Measure	Self-Monitoring and Feedback n=30 Participants The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. 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.	Self-Monitoring n=30 Participants The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. 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.
Total Drinks Consumed	6.76 drinks Standard Error .26	7.07 drinks Standard Error .26

SECONDARY outcome

Timeframe: up to 10 weeks

Population: All randomized participants who started either condition.

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.

Outcome measures

Outcome measures
Measure	Self-Monitoring and Feedback n=30 Participants The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. 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.	Self-Monitoring n=30 Participants The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. 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.
Drinks Per Drinking Day	2.26 drinks per drinking day Standard Error 0.05	2.34 drinks per drinking day Standard Error 0.05

SECONDARY outcome

Timeframe: up to 10 weeks

Population: All randomized participants who started either treatment condition.

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.

Outcome measures

Outcome measures
Measure	Self-Monitoring and Feedback n=30 Participants The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. 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.	Self-Monitoring n=30 Participants The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. 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.
Percent Heavy Drinking Days	18.62 percentage of heavy drinking days Standard Error 1.48	19.83 percentage of heavy drinking days Standard Error 1.49

SECONDARY outcome

Timeframe: up to 10 weeks

Population: All randomized participants who started either treatment condition.

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.

Outcome measures

Outcome measures
Measure	Self-Monitoring and Feedback n=30 Participants The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. 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.	Self-Monitoring n=30 Participants The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. 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.
Percent Abstinent Days	66.04 percentage of abstinent days Standard Error 1.76	65.56 percentage of abstinent days Standard Error 1.78

SECONDARY outcome

Timeframe: baseline, Week 6, and Week 10

Population: All randomized participants who started either treatment condition.

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.

Outcome measures

Outcome measures
Measure	Self-Monitoring and Feedback n=30 Participants The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. 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.	Self-Monitoring n=30 Participants The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. 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.
Alcohol-related Consequences	8.56 score on scale Standard Error .75	8.23 score on scale Standard Error .76

SECONDARY outcome

Timeframe: baseline and Week 10

Population: All randomized participants who started either condition.

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.

Outcome measures

Outcome measures
Measure	Self-Monitoring and Feedback n=30 Participants The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. 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.	Self-Monitoring n=30 Participants The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. 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.
Sleep Quality	50.59 T-score Standard Error .93	50.38 T-score Standard Error .93

SECONDARY outcome

Timeframe: baseline and Week 10

Population: All randomized participants who started either condition.

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.

Outcome measures

Outcome measures
Measure	Self-Monitoring and Feedback n=30 Participants The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. 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.	Self-Monitoring n=30 Participants The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. 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.
Sleep-related Impairment	53.98 T-score Standard Error 1.10	55.05 T-score Standard Error 1.11

SECONDARY outcome

Timeframe: up to 6 weeks

Population: All randomized participants who started either condition.

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.

Outcome measures

Outcome measures
Measure	Self-Monitoring and Feedback n=30 Participants The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. 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.	Self-Monitoring n=30 Participants The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. 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.
Sleep Duration Weeks 1-2	168.73 square root in milliseconds Standard Error 1.37	170.78 square root in milliseconds Standard Error 1.37
Sleep Duration Weeks 3-4	172.18 square root in milliseconds Standard Error 1.37	169.38 square root in milliseconds Standard Error 1.38
Sleep Duration Weeks 5-6	171.74 square root in milliseconds Standard Error 1.37	170.11 square root in milliseconds Standard Error 1.41

SECONDARY outcome

Timeframe: up to 6 weeks

Population: All randomized participants who started either treatment condition.

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.

Outcome measures

Outcome measures
Measure	Self-Monitoring and Feedback n=30 Participants The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. 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.	Self-Monitoring n=30 Participants The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. 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.
Heart Rate Variability (HRV) Weeks 1-2	7.55 milliseconds Standard Error 0.35	7.79 milliseconds Standard Error 0.35
Heart Rate Variability (HRV) Weeks 3-4	7.63 milliseconds Standard Error 0.35	7.81 milliseconds Standard Error 0.35
Heart Rate Variability (HRV) Weeks 5-6	7.68 milliseconds Standard Error 0.35	7.84 milliseconds Standard Error 0.35

SECONDARY outcome

Timeframe: up to 6 weeks

Population: All randomized participants who started either treatment condition.

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.

Outcome measures

Outcome measures
Measure	Self-Monitoring and Feedback n=30 Participants The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. 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.	Self-Monitoring n=30 Participants The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep and related behaviors daily during this time using mobile daily diaries. 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.
Lowest Resting Heart Rate (RHR) Weeks 1-2	4.06 beats per minute Standard Error 0.02	4.03 beats per minute Standard Error 0.02
Lowest Resting Heart Rate (RHR) Weeks 3-4	4.06 beats per minute Standard Error 0.02	4.03 beats per minute Standard Error 0.02
Lowest Resting Heart Rate (RHR) Weeks 5-6	4.05 beats per minute Standard Error 0.02	4.03 beats per minute Standard Error 0.02

Adverse Events

Self-Monitoring and Feedback

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Self-Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lisa Fucito, PhD

Yale University School of Medicine

Phone: 203-200-1470

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place