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

October 21, 2024 updated by: PepsiCo Global R&D

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Bradenton, Florida, United States, 34210
        • Recruiting
        • Gatorade Sports Science Institute (GSSI) at IMG Sports Academy
        • Contact:
          • Kris Osterberg, PhD, RD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
30-60 minutes
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: Hydration Education
30-60 minutes
Other: Water
Prescribed amount of bottled water the evening prior and 2 hours prior to team practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre-practice x 3 practices in Week 1 and 3 practices in Week 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: Change from pre-practice to post-practice x 3 practices in Week 1 and 3 practices in Week 2
Assessed using Tanita portable scale, units recorded to the nearest 0.01 kg
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
Assessed using beverage weight scale. Units recorded to the nearest 1 ml
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
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.
Change from pre-practice to post-practice x 3 practices in Week 1 and 3 practices in Week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PepsiCo Global R&D

Investigators

  • Principal Investigator: Kris Osterberg, PhD, RD, PepsiCo R&D Life Sciences, Sports Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

October 18, 2024

First Submitted That Met QC Criteria

October 18, 2024

First Posted (Actual)

October 22, 2024

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 21, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEP-2406

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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