Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Katherine N Balantekin, PhD, RD · PRINCIPAL_INVESTIGATOR · University at Buffalo
- Elizabeth G Mietlicki-Baase, PhD · PRINCIPAL_INVESTIGATOR · University at Buffalo
- Leonard H Epstein, PhD · PRINCIPAL_INVESTIGATOR · University at Buffalo
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Acceptability of hydration plusAt week 16, which is the end of the program.
Participants will complete a questionnaire measuring acceptability of the program. This will be on a 5 point scale, from 0 meaning completely unacceptable (worse outcome) to 5 meaning completely acceptable (better outcome).
- Feasibility of InterventionAt week 16, which is the end of the program.
Feasibility will be measured through participant completion of study related tasks. Scores will span from 0 to 100, with 0 meaning completed no study procedures (worse outcome) to 100 meaning completed all study procedures (better outcome).
- Change in physiological hydration scoreBaseline (week 0) to week 16 (post - program)
Hydration level will be measured throughout the study using multiple measurements including amount of water consumed from their Bluetooth water bottle, reported non - water beverages on MyNetDiary, urine specific gravity, and urine color will be assessed for hydration biomarkers. Blood will be drawn to assess hydration biomarkers. These are all individual measures of hydration that provide a broader image of hydration. These measures will be combined to create a general hydration score. Scores will range from 0 (hydrated, better outcome) to 10 (dehydrated, worse outcome). Changes from baseline to end of program will be assessed.
- Change in perceived hydration levelWeek -1 (run - in week) to week 16 (end of program)
Perceived hydration will be measured through self-reported questionnaires. The thirst scale, thirst sensation scale, and modified perception of thirst scale are validated questionnaires meant to assess thirst level, sensations associated with them, and individual perception of thirst. These surveys will be administered remotely. Survey data will be combined to create one overall perceived hydration score. Scores can range from 1 (meaning not dehydrated, better outcome) to 119 (meaning extremely dehydrated, worse outcome). Changes from the run - in week to end of program will be assessed.