A Photoplethysmography Sensor-based Personalized Feedback Intervention for Heavy-drinking Young Adults Targeting Heart Rate Variability, Resting Heart Rate, and Sleep
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Total Drinks Consumed
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Behavioral Self-Management and Feedback (Behavioral)
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.
干预措施: Behavioral Self-Management (Behavioral)
结局指标
主要结局
Total Drinks Consumed
时间窗: 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.
次要结局
- 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)
- Sleep-related Impairment(baseline and Week 10)
- Sleep Duration(up to 6 weeks)
- Heart Rate Variability (HRV)(up to 6 weeks)
- Lowest Resting Heart Rate (RHR)(up to 6 weeks)