Hydration, Ergonomic Risk, and Fatigue Across Multiple PepsiCo Facilities
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Fluid Balance
研究概览
简要总结
Physically demanding occupations require high levels of energy expenditure, mental sharpness, and technical skills, and are often performed in extreme environments during hot/humid summer months. Previous research shows dehydration and heat stress can increase risk of heat-related illness, reduce cognitive function, and work capacity. The relationship between hydration status and occupational physical and environmental demands has yet to be fully understood and compared across occupations. This study will examine hydration, sweat profile, activity level and its association with ergonomic risk (high, moderate, and mild risk movement patterns performed during work) and fatigue to improve our understanding of the hydration needs of warehouse workers.
研究设计
- 研究类型
- 观察性
- 观察模型
- 仅病例
- 时间视角
- 横断面
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- Participant self-identifies as a healthy male or female
- Participant is 18-65 years of age
- Participant has worked for their employer for at least 2 months
- Participant is willing to agree to the protocol outlined in the informed consent form
排除标准
- Participant has an allergy to adhesives
- Female participant is pregnant or nursing
- Optional Core Temperature Pill Monitoring exclusion:
- You have a known or suspected obstructive disease of the gastrointestinal (GI) tract
- You have a disordered gag reflex
- You have had a previous GI surgery
- You have felinization of the esophagus
- You have hypomotility disorders of the GI tract
- You have a cardiac pacemaker or other implanted electromedical devices
- You might undergo MRI scanning during the period the ingested capsule was within the body
研究组 & 干预措施
Observational
PepsiCo Frontline Workers
结局指标
主要结局
Fluid Balance
时间窗: Day 1, over 8-12 hour shift
Fluid Intake (mL) - sweat losses (mL)
Urine Color
时间窗: Day 1, 15 minutes pre- 8-12 hour shift and 15 minutes post- 8-12 hour shift
1=most dilute to 7= least dilute, with higher scores associated with a dehydration and a poorer outcome.
Internal Workload
时间窗: Day 1, over 8-12 hour shift
Average Heart Rate (beats per minute)
Ergonomic Risk
时间窗: Day 1, over 8-12 hour shift
Assessed using the LifeBooster Senz devices. Device measures frequency and severity of movements and posture
Self-reported Changes in Fatigue
时间窗: Day 1, 15 minutes pre- and 15 minutes post- 8-12 hour shift
Mental and Physical Energy and Fatigue. Visual Analog Scale (VAS): 6 questions to describe capacity for physical activity anchored from No to Strongest Feelings and 6 questions describe capacity for mental activity anchored from No to Strongest Feelings.
次要结局
- Sweat Rate(Day 1, over an 8-12 hour shift)
- Sweat Sodium Concentration(Day 1, over an 8-12 hour shift)
- Fluid Intake(Day 1, Each time water bottle is refilled over 8-12 hour shift)
- Urine Specific Gravity(Day 1, Post-shift USG compared to pre-shift USG (8-12 hours from baseline))
- Estimated Energy Expenditure(Day 1, over 8-12 hour shift)
- Core Temperature(over 8-12 hour shift)
- Environmental Conditions(Day 1, pre-, mid-, and post-shift over 8-12 hour shift.)
- Adverse Events(Through study completion, an average of 1 day.)
研究者
研究点 (2)
标识符
- NCT 编号
- NCT07848256
- 其他研究编号
- PEP-2608
日期
- 首次提交
- (14天前)
- 首次发布
- (昨天)
- 主要完成日期
- (2个月后)
- 研究完成日期
- (3个月后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否