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NCT Number: NCT06651619

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

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.

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Key information

Conditions

Dehydration Behavior Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Water-Electrolyte Imbalance

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gatorade Sports Science Institute (GSSI) at IMG Sports Academy

Bradenton, Florida, 34210, United States

Location status: Recruiting

Location contact

Kris Osterberg, PhD, RD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water

Other

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

Hydration Education

Other

30-60 minutes

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kris Osterberg, PhD, RD

CONTACT

[email protected]

(941) 201 3820

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 22, 2024
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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