NCT05090995

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

February 23, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

December 13, 2024

Completed
Last Updated

December 13, 2024

Status Verified

November 1, 2024

Enrollment Period

1.3 years

First QC Date

October 11, 2021

Results QC Date

May 30, 2024

Last Update Submit

November 18, 2024

Conditions

Heavy DrinkingHarmful; Use, Alcohol

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to Week 10

Secondary Outcomes (9)

  • Drinks Per Drinking Day

    up to 10 weeks

  • Percent Heavy Drinking Days

    up to 10 weeks

  • Percent Abstinent Days

    up to 10 weeks

  • Alcohol-related Consequences

    baseline, Week 6, and Week 10

  • Sleep Quality

    baseline and Week 10

  • +4 more secondary outcomes

Study Arms (2)

Self-Monitoring and Feedback

ACTIVE COMPARATOR

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

Self-Monitoring

PLACEBO COMPARATOR

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

Interventions

Behavioral Self-Management and FeedbackBEHAVIORAL

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 and Feedback
Behavioral Self-ManagementBEHAVIORAL

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.

Self-Monitoring

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

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Results Point of Contact

Title
Lisa Fucito, PhD
Organization
Yale University School of Medicine
Lisa.fucito@yale.edu
203-200-1470

Study Officials

  • Lisa Fucito, PhD

    Associate Professor of Psychiatry; Director, Tobacco Treatment Service, Psychiatry

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2021

First Posted

October 25, 2021

Study Start

February 23, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

December 13, 2024

Results First Posted

December 13, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)