Feasibility of Using the Gatorade Sports Science Institute (GSSI) Labs App for Hydration Related Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hydration assessment via mobile app.
- Who it may be relevant to
- Registry conditions: Hydration. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
This remote study will evaluate the feasibility of using the Gatorade Sports Science Institute (GSSI) Labs App for remotely collecting hydration related outcomes.
Detailed description
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.
Interventions
- Other Hydration assessment via mobile app
Open the Gatorade Sports Science Institute (GSSI) branded mobile application and click on 'Complete Hydration Assessment'
Primary outcome measures
- User engagement and feasibility: Subjective and self-reported markers of hydration status [Time frame: 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) [Time frame: At two identical 2-hour study sessions with at least one full day and a maximum of 6 days in between study sessions]
Secondary outcome measures (1)
- Understand the within subject variability of TOI features before and after acute fluid ingestion during remote data collection [Time frame: At two identical 2-hour study sessions with at least one full day and a maximum of 6 days in between study sessions]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Advanced Personalized Ideation Center (API) and Gatorade Sports Science Institute (GSSI), — Chicago
Identifiers
NCT: NCT07005895 · PEP-2503