- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06651619
Eficacia de la educación versus la educación más la ingesta de líquidos prescritas sobre el estado de hidratación en atletas de secundaria
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Florida
-
Bradenton, Florida, Estados Unidos, 34210
- Gatorade Sports Science Institute (GSSI) at IMG Sports Academy
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: 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). |
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). |
30-60 minutes Prescribed amount of bottled water the evening prior and 2 hours prior to team practice |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
urine specific gravity (USG).
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Body weight
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kris Osterberg, PhD, RD, PepsiCo R&D Life Sciences, Sports Science
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades metabólicas
- Desequilibrio de agua y electrolitos
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Deshidración
- Actividad del motor
- Comportamiento
- Químicos inorgánicos
- Aniones
- Iones
- Electrolitos
- Hidróxidos
- Álcalies
- Óxidos
- Compuestos de oxígeno
- Agua
Otros números de identificación del estudio
- PEP-2406
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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