NCT06954909

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

April 17, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

April 22, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 2, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2026

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

April 17, 2025

Last Update Submit

January 26, 2026

Conditions

Keywords

Urine osmolalityUrine specific gravityLabelled water (D20)DeuteriumEducationSelf-assessmentTactical operatorsFirefightersWomenMenHealthy subjects

Outcome Measures

Primary Outcomes (2)

  • Fluid turnover

    Fluid turnover based on D2O analysis

    Over a period of 4 days, in two 48-hour segments.

  • Urine concentration

    Urine concentration (osmolality).

    Afternoon sample day 1, morning sample day 2/4/6

Secondary Outcomes (8)

  • Urine concentration

    Afternoon sample day 1, morning (and potential afternoon) samples day 1/2/3/4/5/6.

  • Activity

    Throughout the study during working hours, which may vary between 8-16 hours per working day.

  • Hydration strategy

    Day 6 of the data collection, covering the hydration strategy during the study period.

  • Heat stress

    Throughout the study during working hours, which may vary between 8-16 hours per working day.

  • INT: Self-reported hydration measures

    Study days 2/3/4/5/6.

  • +3 more secondary outcomes

Other Outcomes (4)

  • Demographics

    Measured at the start of the study during Part I (screening phase).

  • Environmental conditions

    Throughout the study during working hours, which may vary between 8-16 hours per working day.

  • Environmental conditions

    Throughout the study during working hours, which may vary between 8-16 hours per working day.

  • +1 more other outcomes

Study Arms (2)

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.

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.

Interventions

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.

Hydration education and hydration self-assessment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Age 18-65 years
  • Identifying as male, female or other
  • Thyroid medication
  • Bariatric surgery
  • Cardiovascular disease
  • Renal disease
  • Hepatic disease
  • Bodyweight \<110 lbs.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASU Health Futures Center

Phoenix, Arizona, 85054, United States

Location

Related Publications (1)

  • 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.

    PMID: 33416980BACKGROUND

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Interventions

Diagnostic Self Evaluation

Condition Hierarchy (Ancestors)

Multiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Nutrition

Study Record Dates

First Submitted

April 17, 2025

First Posted

May 2, 2025

Study Start

April 22, 2025

Primary Completion

February 12, 2026

Study Completion

February 13, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations