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Recruiting NCT06651619

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

No phase Interventional Dehydration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Water, Hydration Education.
Who it may be relevant to
Registry conditions: Dehydration. Basic parameters: 13 years — 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Water
    Prescribed amount of bottled water the evening prior and 2 hours prior to team practice
  • Other Hydration Education
    30-60 minutes

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Gatorade Sports Science Institute (GSSI) at IMG Sports Academy — Bradenton

Identifiers

NCT: NCT06651619 · PEP-2406

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗