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

NCT06651619 | Recruiting

• 1 other identifier: PEP-2406
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• urine specific gravity (USG).

  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 Outcomes (3)

• Body weight

  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)

  Intake from evening before through post-practice x 3 practices in Week 2

• Thirst questionnaire

  Change from pre-practice to post-practice x 3 practices in Week 1 and 3 practices in Week 2

Study Arms (3)

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).

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).

Other: Water; Other: Hydration Education

Interventions

Water OTHER

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

Hydration Education between Week 1 and Week 2 plus Prescribed Hydration Week 2

Hydration Education OTHER

30-60 minutes

Hydration Education between Week 1 and Week 2; Hydration Education between Week 1 and Week 2 plus Prescribed Hydration Week 2

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

Gatorade Sports Science Institute (GSSI) at IMG Sports Academy

Bradenton, Florida, 34210, United States

RECRUITING

MeSH Terms

Conditions

Dehydration; Motor Activity; Behavior

Interventions

Water

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Kris Osterberg, PhD, RD

  PepsiCo R&D Life Sciences, Sports Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kris Osterberg, PhD, RD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 22, 2024
• Study Start: October 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)