DehydrationNCT06651619
Efficacy of Education Versus Education Plus Prescribed Fluid Intake on Hydration Status in High School Athletes
A study testing Water and Hydration Education in people with Dehydration, run by PepsiCo Global R&D at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- What is being tested?
- Water and Hydration Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2024to 19 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Females and males between the ages of 13-19 years old
- Non-smoker
- Currently enrolled in the IMG sports program
- Able to give verbal and written informed consent for participation as well as obtain parental consent if <18 years of age
- Must be fluent in English reading, writing, and speaking
- Parental permission
Who cannot join
- Expulsion from school for any reason
- Leaving the IMG sports program
- Pregnant or planning to become pregnant
- Illness or injury that impacts sport participation or fluid balance
- Taking any medication that impacts fluid balance
- Participation in a clinical trial within past 30 days
- Participation in any PepsiCo trial within past 6 months
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Gatorade Sports Science Institute (GSSI) at IMG Sports Academy
Bradenton, Florida, 34210
About this study
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.
- Conditions
- Dehydration
- Being tested
- Water, Hydration Education
- Keywords
- hydration, hypohydration, adolescent, athlete, sports, exercise, behavior, education, high school
- Medical subject headings
- Dehydration, Motor Activity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterOther
Prescribed amount of bottled water the evening prior and 2 hours prior to team practice
Hydration EducationOther
30-60 minutes
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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) . |
| Hydration Education between Week 1 and Week 2 | Experimental | 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). Receives: Other: Hydration Education |
| Hydration Education between Week 1 and Week 2 plus Prescribed Hydration Week 2 | Experimental | 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). Receives: Other: Water; Other: Hydration Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
urine specific gravity (USG).
Assessed using hand-held refractometer, units recorded to the nearest 0.001
Measured: Pre-practice x 3 practices in Week 1 and 3 practices in Week 2
Secondary outcomes (3)
Body weight
Assessed using Tanita portable scale, units recorded to the nearest 0.01 kg
Measured: Change from pre-practice to post-practice x 3 practices in Week 1 and 3 practices in Week 2
Fluid intake Week 2 (measured for Prescription Group only)
Assessed using beverage weight scale. Units recorded to the nearest 1 ml
Measured: Intake from evening before through post-practice x 3 practices in Week 2
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.
Measured: Change from pre-practice to post-practice x 3 practices in Week 1 and 3 practices in Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start18 Nov 2024
- Primary completion19 Nov 2025
- Study completion19 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kris Osterberg, PhD, RD, Principal investigator, PepsiCo R&D Life Sciences, Sports Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651619
- Sponsor's protocol ID
- PEP-2406
- Status last verified
- Sep 2026
- First submitted
- 18 Oct 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Education Versus Education Plus Prescribed Fluid Intake on Hydration Status in High School Athletes
- ClinicalTrials.gov ID
- NCT06651619
- Acronym / sponsor ID
- PEP-2406
- Conditions
- Dehydration
- Keywords
- hydration, hypohydration, adolescent, athlete, sports, exercise, behavior, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 19 Nov 2025 (actual)
- First posted
- 22 Oct 2024 (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.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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) . |
| Hydration Education between Week 1 and Week 2 | Experimental | Other: Hydration EducationIn-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). |
| Hydration Education between Week 1 and Week 2 plus Prescribed Hydration Week 2 | Experimental | Other: Water, Other: Hydration EducationIn-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). |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Females and males between the ages of 13-19 years old
- Non-smoker
- Currently enrolled in the IMG sports program
- Able to give verbal and written informed consent for participation as well as obtain parental consent if <18 years of age
- Must be fluent in English reading, writing, and speaking
Key exclusion criteria (8 listed)
- Expulsion from school for any reason
- Leaving the IMG sports program
- Pregnant or planning to become pregnant
- Illness or injury that impacts sport participation or fluid balance
- Taking any medication that impacts fluid balance
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 |
|---|---|---|
| WaterPrescribed amount of bottled water the evening prior and 2 hours prior to team practice | Other | Hydration Education between Week 1 and Week 2 plus Prescribed Hydration Week 2 |
| Hydration Education30-60 minutes | Other | Hydration Education between Week 1 and Week 2, Hydration Education between Week 1 and Week 2 plus Prescribed Hydration Week 2 |
Primary outcome
urine specific gravity (USG).
Time frame: Pre-practice x 3 practices in Week 1 and 3 practices in Week 2
Assessed using hand-held refractometer, units recorded to the nearest 0.001
3 secondary outcomes
Body weight
Time frame: Change from pre-practice to post-practice x 3 practices in Week 1 and 3 practices in Week 2
Fluid intake Week 2 (measured for Prescription Group only)
Time frame: Intake from evening before through post-practice x 3 practices in Week 2
Thirst questionnaire
Time frame: Change from pre-practice to post-practice x 3 practices in Week 1 and 3 practices in Week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Dehydration
Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Enrolling by invitation
Hypernatremia Fluid Therapy in Childhood Diarrhoea
Hypernatremia, Acute Watery Diarrhea
Not yet recruitingPhase 2
Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera
Cholera (Disorder)
Recruiting
Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
Obesity & Overweight, Type 2 Diabetes
Recruiting
Hydration & Female Life Stages
Dehydration, Menstruation
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. This study is not recruiting at the moment.
Kris Osterberg, PhD, RD principal investigator
PepsiCo R&D Life Sciences, Sports Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water and Hydration Education in people with Dehydration, run by PepsiCo Global R&D 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 21 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
urine specific gravity (USG). (time frame: Pre-practice x 3 practices in Week 1 and 3 practices in Week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2026.