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Идёт набор NCT07005895

Feasibility of Using the Gatorade Sports Science Institute (GSSI) Labs App for Hydration Related Outcomes

— Наблюдательное Hydration

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Hydration assessment via mobile app.
Кому может быть актуально
Состояния в реестре: Hydration. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Feasibility of Using the Gatorade Sports Science Institute (GSSI) Labs App for Hydration Related Outcomes: User Engagement and Individual Variability of Transdermal Optical Imaging Features Before and After Acute Fluid Ingestion

Обзор

This remote study will evaluate the feasibility of using the Gatorade Sports Science Institute (GSSI) Labs App for remotely collecting hydration related outcomes.

Подробное описание

The primary objective is to understand user engagement and feasibility of remotely collecting subjective and self-reported markers of hydration status as well as markers of hydration using transdermal optical imaging (TOI) within the Gatorade Sports Science Institute (GSSI) branded mobile application (adherence and dropout rates, and differences between demographics). The secondary objective is to understand the within subject variability of TOI features before and after acute fluid ingestion during remote data collection.

Tertiary objectives are to compare self-reported measures of hydration status against the TOI hydration model prediction before and after acute fluid ingestion during remote data collection.

An outside service was contracted for recruiting. Please do not contact the investigator to express interest.

Вмешательства

  • Другое Hydration assessment via mobile app
    Open the Gatorade Sports Science Institute (GSSI) branded mobile application and click on 'Complete Hydration Assessment'

Первичные конечные точки

  • User engagement and feasibility: Subjective and self-reported markers of hydration status [Срок оценки: At two identical 2-hour study sessions with at least one full day and a maximum of 6 days in between study sessions]
  • User engagement and feasibility: Markers of hydration using transdermal optical imaging (TOI) [Срок оценки: At two identical 2-hour study sessions with at least one full day and a maximum of 6 days in between study sessions]
Вторичные конечные точки (1)
  • Understand the within subject variability of TOI features before and after acute fluid ingestion during remote data collection [Срок оценки: At two identical 2-hour study sessions with at least one full day and a maximum of 6 days in between study sessions]

Критерии участия

Критерии включения

  • 18-65 years of age, inclusive
  • Male or female. If female, subject is not pregnant, planning to get pregnant, or currently breast feeding
  • Able to speak, write, and read English
  • Provision of written consent to participate
  • Owns and wears an activity tracker daily, including during sleep, except when submerged underwater (i.e., swimming, bathing) and is willing to connect their device to the app, per GSSI Labs App requirements (Oura, WHOOP, Apple Watch, Garmin, Polar, Withings, or Fitbit).
  • Owns a bathroom scale
  • Able to drink 600mL (600 mL = 20 oz = 2 ½ cups) of water as directed.
  • Willing to avoid alcohol consumption 24 hours prior to study session(s)

Критерии исключения

  • Subject is currently enrolled in a clinical trial or has participated in a clinical trial within the past 30 days.
  • Subject is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If subject is unsure if a company would be considered a competitor to Gatorade, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

США · 1 центр
  • Advanced Personalized Ideation Center (API) and Gatorade Sports Science Institute (GSSI), — Chicago

Идентификаторы

NCT: NCT07005895 · PEP-2503

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗