ClinicalTrials.gg
CompletedNCT06651619Updated Sep 21, 2026

Efficacy of Education Versus Education Plus Prescribed Fluid Intake on Hydration Status in High School Athletes

An interventional study of Water and Hydration Education in Dehydration, sponsored by PepsiCo Global R&D. Completed at 1 site in United States. Open to participants aged 13 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by PepsiCo Global R&D (part of PepsiCo, Inc.) · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
131
Allocation
Randomized
Ages
13 Years to 19 Years
Sex
All
01

Study summary

Sports science testing by investigators at Gatorade Sports Science Institute has revealed that many athletes arrive at practice with a high urine specific gravity indicating they are hypohydrated. Though the data showed that most athletes don't lose more than 2% of their body weight in sweat during a training session, it is not known what the cumulative effects of living and training in a hot environment are over the course of a week. Previous research has indicated that prescribing fluid intake is more effective than education in improving drinking behavior during exercise. No studies to date have compared the impact of fluid intake prescription versus education in adolescent boys and girls playing outdoor and indoor sports.

Comparing sexes and training environment may provide more clarity around potential barriers and challenges to proper hydration for each environment.

Read the detailed description

This study will implement a parallel design with 4 sports team groups: 1) Indoor girls, 2) Indoor boys, 3) Outdoor girls, and 4) Outdoor boys. Each group of 36 per groups will be randomized into 1 of 3 conditions: 1) control (no intervention), 2) hydration education intervention, 3) prescribed hydration and education intervention. Athletes will be observed for three practices per week for 2 weeks. Practices are separated by at least 48 hours.

02

Conditions studied

  • Dehydration

Keywords

  • hydration
  • hypohydration
  • adolescent
  • athlete
  • sports
  • exercise
  • behavior
  • education
  • high school
03

In context

Dehydration

201 studies on the registry are indexed under Dehydration; 28 are open to participants now.

This study's enrollment of 131 is above the median of 43 across 145 interventional studies indexed under Dehydration.

Browse Dehydration studies →

Lead sponsor

PepsiCo Global R&D is the lead sponsor of 103 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Females and males between the ages of 13-19 years old
  2. Non-smoker
  3. Currently enrolled in the IMG sports program
  4. Able to give verbal and written for participation as well as obtain parental consent if \<18 years of age
  5. Must be fluent in English reading, writing, and speaking
  6. Parental permission

Exclusion criteria

Exclusion Criteria:

  1. Expulsion from school for any reason
  2. Leaving the IMG sports program
  3. Pregnant or planning to become pregnant
  4. Illness or injury that impacts sport participation or fluid balance
  5. Taking any medication that impacts fluid balance
  6. Participation in a clinical trial within past 30 days
  7. Participation in any PepsiCo trial within past 6 months
  8. Any condition the study investigator believes would interfere with eligibility following the study protocol, effect the study results, or put the subject at undue risk
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
131 participants (actual)

Study arms

  • No intervention
    Control

    No hydration education or fluid prescription. Pre-practice urine specific gravity (USG), pre- and post-practice body mass, thirst scale measures. Fluid intake during practice (whatever the team is drinking) .

  • Experimental
    Hydration Education between Week 1 and Week 2

    In-depth education session regarding the effects of dehydration, the performance benefits of proper hydration, and how to properly hydrate before, during, and after activity. Pre-practice urine specific gravity (USG), pre- and post-practice body mass, thirst scale measures. Fluid intake during practice (whatever the team is drinking).

    Other: Hydration Education

  • Experimental
    Hydration Education between Week 1 and Week 2 plus Prescribed Hydration Week 2

    In-depth education session regarding the effects of dehydration, the performance benefits of proper hydration, and how to properly hydrate before, during, and after activity. Pre-practice urine specific gravity (USG), pre- and post-practice body mass, thirst scale measures. Provided a standard amount of bottled water to drink the evening prior (1 liter) and in the two hours before practice (20 oz). Fluid intake will be recorded in an intake log. Subjects will be permitted to eat or drink whatever they like in addition to the prescribed fluid. Fluid intake during practice (whatever the team is drinking).

    Other: Water · Other: Hydration Education

Interventions

  • OtherWater

    Prescribed amount of bottled water the evening prior and 2 hours prior to team practice

  • OtherHydration Education

    30-60 minutes

06

What researchers measure

Primary outcomes

  1. urine specific gravity (USG).

    Assessed using hand-held refractometer, units recorded to the nearest 0.001

    Time frame: Pre-practice x 3 practices in Week 1 and 3 practices in Week 2

Secondary outcomes

  1. Body weight

    Assessed using Tanita portable scale, units recorded to the nearest 0.01 kg

    Time frame: Change from pre-practice to post-practice x 3 practices in Week 1 and 3 practices in Week 2

  2. Fluid intake Week 2 (measured for Prescription Group only)

    Assessed using beverage weight scale. Units recorded to the nearest 1 ml

    Time frame: Intake from evening before through post-practice x 3 practices in Week 2

  3. Thirst questionnaire

    6 items (thirst, pleasure to drink now, mouth feel, taste, stomach fullness, stomach sickness) each anchored from not at all to very, each on a 100 mm scale.

    Time frame: Change from pre-practice to post-practice x 3 practices in Week 1 and 3 practices in Week 2

07

Study locations

1 site
  • Gatorade Sports Science Institute (GSSI) at IMG Sports Academy
    Bradenton, Florida 34210, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2024 to primary completion in Nov 2025, 12 months.

Of 73 interventional studies with no phase under Dehydration, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's 12 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2024
First posted
Oct 22, 2024
StartActual
Nov 18, 2024
Primary completionActual
Nov 19, 2025
CompletionActual
Nov 19, 2025
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06651619
Lead sponsor
PepsiCo Global R&D
Responsible party
Sponsor
First posted
Oct 22, 2024
Start date
Nov 18, 2024
Primary completion
Nov 19, 2025
Completion
Nov 19, 2025
Last update
Sep 21, 2026

Study contacts

Kris Osterberg, PhD, RD
principal investigator · PepsiCo R&D Life Sciences, Sports Science

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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