ASU Health Futures Center
Phoenix, Arizona, 85054, United States
NCT Number: NCT06954909
The studies objective is to assess the efficacy of hydration education and the use of a self-assessment worksheet vs. a no-intervention control on improving fluid intake and hydration status in underhydrated wildland firefighters (WLFFs) and their surrogates.
Part I allows to understand hydration status of the participants (screening phase), Part II confirms if participants indeed are deemed to be low fluid consumers, and Part III of this research is a clinical trial that will focus on the optimization of hydration by improving fluid intake (and as a result lowering urine concentration) allowing participants theoretically to improve exercise performance (acute) and optimize health on the long term.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Phoenix, Arizona, 85054, United States
Enrollment will take place until enough people have been screened and be eligible to be enrolled in PART III of the study.
Aside from allowing the investigators to better understand the hydration status of participants in PART I, this part will help to determine potentially eligible participants that can be confirmed through PART II by collecting again a urine sample, and if again concentrated urine is confirmed the research team will take a 5 mL venous blood draw performed by a trained phlebotomist to confirm elevated a copeptin level. These confirmed participants can then be enrolled in PART III of the study when eligible.
PART I includes all participants:
Two urine samples and questionnaire at one day. Expected duration of 2-3 minutes per urine sample and 2-3 minutes for the participant demographics questionnaire which will also be used as a screener to identify eligibility for PART II and III.
PART II includes a smaller sample:
Collection of a urine sample and a blood sample at one follow up day for the duration of 10 minutes.
PART III, the intervention study (being a clinical trial):
Includes n=38 participants, that will invest a maximum of 2 hours and 15 minutes as part of the data collection over a period of 6 days, which includes:
Allocation to INT or CON depends on the total number of participants at different locations that will be eligible. The investigators will try to match participants based on their sex, age and bodyweight, and then randomly assign these matched participants to the intervention or placebo.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
The study plans to include firefighters from the Tonto National Forest and the broader Phoenix Valley area, and if needed, other active populations that are similarly active to WLFFs. Participants with high urine concentration (≥1.020 USG) for both samples collected during Part I (screening phase), may be invited to provide an additional urine sample and a blood sample for copeptin analysis during a follow up day (Part II). Participants with elevated USG and copeptin are eligible to participate in the study.
Inclusion for PART I is that participants are part of a by the research selected wildland firefighter population (or surrogate population), no further exclusion criteria are followed for PART I. For Part II and Part III the following criteria apply:
Inclusion criteria
Exclusion criteria
Investigators will not exclude participants reporting the use of dietary supplements as there is no evidence that the accuracy of self-assessment (specifically the accuracy of urine color assessment) to determine a low vs. high urine concentration is influenced by dietary supplement use, but participants will be questioned about their supplement, electrolyte and sport drink use.
Hydration education is a 25-minute session based on the theory of planned behavior, including the instructions how to use a worksheet for hydration self-assessment and materials.
Time frame: Over a period of 4 days, in two 48-hour segments.
Fluid turnover based on D2O analysis
Time frame: Afternoon sample day 1, morning sample day 2/4/6
Urine concentration (osmolality).
Time frame: Afternoon sample day 1, morning (and potential afternoon) samples day 1/2/3/4/5/6.
Urine concentration (USG ) for morning and when available afternoon/evening samples.
Time frame: Throughout the study during working hours, which may vary between 8-16 hours per working day.
Activity pattern using an activity tracker attached to the upper arm to allow comparing activity between INT and CON.
Time frame: Day 6 of the data collection, covering the hydration strategy during the study period.
Retrospective hydration strategy (questionnaire) of INT and CON.
Time frame: Throughout the study during working hours, which may vary between 8-16 hours per working day.
Direct experienced environmental heat, measured by a heat sensor mounted on helmet or gear.
Time frame: Study days 2/3/4/5/6.
Self-reported hydration measures in INT only (daily fluid intake in mL).
Time frame: Study days 2/3/4/5/6.
Self-reported hydration measures in INT only (urine frequency, number of voids per 24-hour).
Time frame: Study days 2/3/4/5/6.
Self-reported hydration measures in INT only (first morning urine volume in mL).
Time frame: Study days 2/3/4/5/6.
Self-reported hydration measures in INT only (urine color, assessed on a scale from 1-7 ranging from light to dark).
Time frame: Measured at the start of the study during Part I (screening phase).
Personal demographics, such as age, sex, race, ethnicity, work location, work status, short medical history, use of medication, use of dietary supplements, electrolyte and sports drinks, alcohol and tobacco use (questionnaire)
Time frame: Throughout the study during working hours, which may vary between 8-16 hours per working day.
Environmental measurements using a local weather station to be able to report ambient temperature in degrees Celsius.
Time frame: Throughout the study during working hours, which may vary between 8-16 hours per working day.
Environmental measurements using a local weather station to be able to report relative humidity (%).
Time frame: Throughout the study during working hours, which may vary between 8-16 hours per working day.
Environmental measurements using a local weather station to be able to report solar radiation in watts per square meter (W/m2 = Wm-2).
Arizona State University
Other
The Impact of Self-assessment on Wildland Firefighter and Surrogate Population Hydration
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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