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Eine Studie entspricht den Filterkriterien
Kartenansicht
Efficacy of Education Versus Education Plus Prescribed Fluid Intake on Hydration Status in High School Athletes
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06651619 ist eine interventionsstudie zur Untersuchung von Dehydration und hat den Status offene rekrutierung. Die Studie startete am 1. Oktober 2024 und soll 108 Teilnehmer aufnehmen. Durchgeführt von PepsiCo Global R&D ist der Abschluss für 30. Juni 2025 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 23. Oktober 2024 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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.
Offizieller Titel
Efficacy of Education Versus Education Plus Prescribed Fluid Intake on Hydration Status in High School Athletes
Erkrankungen
DehydrationWeitere Studien-IDs
- PEP-2406
NCT-Nummer
Studienbeginn (tatsächlich)
2024-10-01
Zuletzt aktualisiert
2024-10-23
Studienende (vorauss.)
2025-06-30
Geplante Rekrutierung
108
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
hydration
hypohydration
adolescent
athlete
sports
exercise
behavior
education
high school
hypohydration
adolescent
athlete
sports
exercise
behavior
education
high school
Primäres Ziel
Grundlagenforschung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Keine InterventionControl 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) . | Nicht zutreffend |
ExperimentellHydration 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). | Hydration Education 30-60 minutes |
ExperimentellHydration 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). | Wasser Prescribed amount of bottled water the evening prior and 2 hours prior to team practice Hydration Education 30-60 minutes |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Body weight | 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) | 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 | 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 |
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene
Mindestalter
13 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
- 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
- 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
Zentrale Studienkontakte
Kontakt: Kris Osterberg, PhD, RD, (941) 201 3820, [email protected]
1 Studienstandorte in 1 Ländern
Florida
Gatorade Sports Science Institute (GSSI) at IMG Sports Academy, Bradenton, Florida, 34210, United States
Kris Osterberg, PhD, RD, Kontakt
Offene Rekrutierung