Hydration StatusNCT06954909
The Impact of Self-assessment on Hydration
A study testing Hydration education and self-assessment in people with Hydration Status, run by Arizona State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydration Status
- What is being tested?
- Hydration education and self-assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Identifying as male, female or other
Who cannot join
- Thyroid medication
- Bariatric surgery
- Cardiovascular disease
- Renal disease
- Hepatic disease
- Bodyweight <110 lbs.
Show all 11Show fewer
- Any injury that would not allow physical performance or activity
- Pregnant or lactating
- Diuretics
- Non-stable self-reported body weight for the last month (<10 lbs. fluctuation)
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Impact of Self-assessment on Wildland Firefighter and Surrogate Population Hydration
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.
Read the detailed description
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:
- Education session (pre: INT, or post: CON) of 25 minutes.
- Consuming labelled water and providing a urine sample and bodyweight the day before the start of the study, 10-15 minutes.
- Participate in the study for 6 days (during normal work days) and bodyweight will be measured at day 2, 4 and 6 of the study, during all study days both INT and CON will provide a morning urine sample (and if possible an afternoon/evening sample after work), and during each days sensors will be attached to participants upper arm and gear, 5 minutes per day, 25-30 minutes total.
- The intervention group will track its use of the tools we have provided them with, while the other group will not perform any additional self-assessments during the study period, 10 minutes per day 25-50 minutes total.
- Final hydration strategy questionnaire for INT and CON, 5-10 minutes.
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.
- Conditions
- Hydration Status
- Being tested
- Hydration education and self-assessment
- Keywords
- Urine osmolality, Urine specific gravity, Labelled water (D20), Deuterium, Education, Self-assessment, Tactical operators, Firefighters, Women, Men, Healthy subjects
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydration education and self-assessmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Hydration education and hydration self-assessment | Experimental | Participants will participate in a 25-minute hydration education session that also includes instruction about how the use the hydration self-assessment worksheets and materials. Receives: Behavioral: Hydration education and self-assessment |
| No Hydration education and hydration self-assessment (business as usual) | No intervention | Participants do not participate in any education or self-assessment, other than applying their normal hydration strategies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid turnover
Fluid turnover based on D2O analysis
Measured: Over a period of 4 days, in two 48-hour segments.
Urine concentration
Urine concentration (osmolality).
Measured: Afternoon sample day 1, morning sample day 2/4/6
Secondary outcomes (8)
Urine concentration
Urine concentration (USG ) for morning and when available afternoon/evening samples.
Measured: Afternoon sample day 1, morning (and potential afternoon) samples day 1/2/3/4/5/6.
Activity
Activity pattern using an activity tracker attached to the upper arm to allow comparing activity between INT and CON.
Measured: Throughout the study during working hours, which may vary between 8-16 hours per working day.
Hydration strategy
Retrospective hydration strategy (questionnaire) of INT and CON.
Measured: Day 6 of the data collection, covering the hydration strategy during the study period.
Heat stress
Direct experienced environmental heat, measured by a heat sensor mounted on helmet or gear.
Measured: Throughout the study during working hours, which may vary between 8-16 hours per working day.
INT: Self-reported hydration measures
Self-reported hydration measures in INT only (daily fluid intake in mL).
Measured: Study days 2/3/4/5/6.
INT: Self-reported hydration measures
Self-reported hydration measures in INT only (urine frequency, number of voids per 24-hour).
Measured: Study days 2/3/4/5/6.
INT: Self-reported hydration measures
Self-reported hydration measures in INT only (first morning urine volume in mL).
Measured: Study days 2/3/4/5/6.
INT: Self-reported hydration measures
Self-reported hydration measures in INT only (urine color, assessed on a scale from 1-7 ranging from light to dark).
Measured: Study days 2/3/4/5/6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start22 Apr 2025
- Primary completion12 Feb 2026
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hydration StatusStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation to intervention (INT) or control (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 control group. The control group participants will be offered to follow the education session after data collection has been finished.
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Emergency Management Agency
- Responsible party
- Principal investigator, Floris Wardenaar, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954909
- Sponsor's protocol ID
- EMW-2022- FP-00082
- Other IDs
- EMW-2022- FP-00082
- Status last verified
- May 2026
- First submitted
- 17 Apr 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wardenaar FC, Thompsett D, Vento KA, Bacalzo D. A lavatory urine color (LUC) chart method can identify hypohydration in a physically active population. Eur J Nutr. 2021 Aug;60(5):2795-2805. doi: 10.1007/s00394-020-02460-5. Epub 2021 Jan 8.
PubMed 33416980
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Self-assessment on Wildland Firefighter and Surrogate Population Hydration
- ClinicalTrials.gov ID
- NCT06954909
- Acronym / sponsor ID
- EMW-2022- FP-00082
- Conditions
- Hydration Status
- Keywords
- Urine osmolality, Urine specific gravity, Labelled water (D20), Deuterium, Education, Self-assessment, Tactical operators, Firefighters
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Federal Emergency Management Agency
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Education session (pre: INT, or post: CON) of 25 minutes.
- Consuming labelled water and providing a urine sample and bodyweight the day before the start of the study, 10-15 minutes.
- Participate in the study for 6 days (during normal work days) and bodyweight will be measured at day 2, 4 and 6 of the study, during all study days both INT and CON will provide a morning urine sample (and if possible an afternoon/evening sample after work), and during each days sensors will be attached to participants upper arm and gear, 5 minutes per day, 25-30 minutes total.
- The intervention group will track its use of the tools we have provided them with, while the other group will not perform any additional self-assessments during the study period, 10 minutes per day 25-50 minutes total.
- Final hydration strategy questionnaire for INT and CON, 5-10 minutes.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Allocation to intervention (INT) or control (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 control group. The control group participants will be offered to follow the education session after data collection has been finished.
| Arm | Type | Receives |
|---|---|---|
| Hydration education and hydration self-assessment | Experimental | Behavioral: Hydration education and self-assessmentParticipants will participate in a 25-minute hydration education session that also includes instruction about how the use the hydration self-assessment worksheets and materials. |
| No Hydration education and hydration self-assessment (business as usual) | No intervention | –Participants do not participate in any education or self-assessment, other than applying their normal hydration strategies. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-65 years
- Identifying as male, female or other
Key exclusion criteria (11 listed)
- Thyroid medication
- Bariatric surgery
- Cardiovascular disease
- Renal disease
- Hepatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydration education and self-assessmentHydration 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. | Behavioural | Hydration education and hydration self-assessment |
Primary outcome
Fluid turnover
Time frame: Over a period of 4 days, in two 48-hour segments.
Fluid turnover based on D2O analysis
Urine concentration
Time frame: Afternoon sample day 1, morning sample day 2/4/6
Urine concentration (osmolality).
8 secondary outcomes
Urine concentration
Time frame: Afternoon sample day 1, morning (and potential afternoon) samples day 1/2/3/4/5/6.
Activity
Time frame: Throughout the study during working hours, which may vary between 8-16 hours per working day.
Hydration strategy
Time frame: Day 6 of the data collection, covering the hydration strategy during the study period.
Heat stress
Time frame: Throughout the study during working hours, which may vary between 8-16 hours per working day.
INT: Self-reported hydration measures
Time frame: Study days 2/3/4/5/6.
INT: Self-reported hydration measures
Time frame: Study days 2/3/4/5/6.
INT: Self-reported hydration measures
Time frame: Study days 2/3/4/5/6.
INT: Self-reported hydration measures
Time frame: Study days 2/3/4/5/6.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 33416980Wardenaar FC, Thompsett D, Vento KA, Bacalzo D. A lavatory urine color (LUC) chart method can identify hypohydration in a physically active population. Eur J Nutr. 2021 Aug;60(5):2795-2805. doi: 10.1007/s00394-020-02460-5. Epub 2021 Jan 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydration education and self-assessment in people with Hydration Status, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid turnover (time frame: Over a period of 4 days, in two 48-hour segments.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06954909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.