Recruiting

Education vs. Education Plus Fluid

Sponsor:

PepsiCo Global R&D

Code:

NCT06651619

Conditions

Dehydration

Eligibility Criteria

Sex: All

Age: 13 - 19

Healthy Volunteers: Accepted

Interventions

Water

Hydration Education

Study Details

Brief 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.

Conditions

Dehydration

Study ID

NCT06651619

Start date

Oct 1, 2024

Status verified date

Oct, 2024

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 19

Healthy Volunteers: Accepted

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 informed consent 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:

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

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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).

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).

Interventions

Water

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

Hydration Education

30-60 minutes

Primary outcome measure

  • urine specific gravity (USG). [ Time Frame: Pre-practice x 3 practices in Week 1 and 3 practices in Week 2 ]

Central Contacts and Locations

Central contacts

Kris Osterberg, PhD, RD

(941) 201 3820Kris.Osterberg@pepsico.com

Locations

Gatorade Sports Science Institute (GSSI) at IMG Sports Academy

Recruiting

Bradenton, Florida, United States, 34210

More Information

Sponsor

PepsiCo Global R&D

Last update posted

Oct 23, 2024

Last verified

Oct, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by PepsiCo Global R&D on 2024-10-23.