NCT Number: NCT07641361
This is a 17 - week study consisting of a one - week run - in period and a 16 - week intervention. The 16 - week pilot interventions aims to increase hydration in those beginning GLP - 1 RA therapy. Investigators aim to increase hydration to potentially decrease side effect severity, amount of side effects, and drug discontinuation associated with GLP - 1 RA therapy. The investigators are piloting to assess feasibility and preliminary efficacy of the intervention through examining participant retention, participant feedback, researcher and participant adherence to protocols, impact on hydration biomarkers, and participant reported GLP - 1 RA side effects.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Buffalo, New York, 14214, United States
Location status: Recruiting
Derek Daniels, PhD
SUB_INVESTIGATOR
Elizabeth G Mietlicki-Baase, PhD
PRINCIPAL_INVESTIGATOR
Hannah E Kolpack, BS
CONTACT
Husam Ghanim, PhD
SUB_INVESTIGATOR
Katherine N Balantekin, PhD, RD
PRINCIPAL_INVESTIGATOR
Leonard H Epstein, PhD
PRINCIPAL_INVESTIGATOR
Luke Pryor, PhD, ATC, CSCS
SUB_INVESTIGATOR
Paul Meyer, PhD
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The hydration plus intervention aims to increase hydration through employing the following behavior change strategies/techniques: coaching (consisting of goal setting, making a plan, and coping planning), positive feedback, and utilize a contingency management payment schedule wherein participant earned amount hinges on them meeting their goal.
Participants randomly assigned to the control group will receive information on hydration and will receive prompts to drink.
Time frame: At 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).
Time frame: At 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).
Time frame: Baseline (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.
Time frame: Week -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.
Time frame: Baseline (week 0) and week 16 (post - program)
BMI will be calculated using laboratory - measured weight and height and reported in kg/m^2. Changes from baseline to end of program will be assessed.
Time frame: Baseline (week 0) and week 16 (post - program)
Extracellular water will be measured using a bioelectrical impedance analysis (BIA). BIA consists of a painless, low - intensity electrical current being sent through the body and measuring resistance (impedance) to provide body composition information. Changes from baseline to end of program will be assessed.
Time frame: Baseline (week 0) and week 16 (post - program)
Change in intracellular water will be measured using a bioelectrical impedance analysis (BIA). BIA consists of a painless, low - intensity electrical current being sent through the body and measuring resistance (impedance) to assess various measures of body composition. Changes from baseline to end of program will be assessed.
Time frame: Week - 1 (run - in week) to week 16 (end of program)
Severity and amount of side effects of GLP - 1 RA's will be measured using a questionnaire that assesses the side effect symptoms and symptom severity an individual experiences while being on a GLP - 1 RA. Scores can range from 0 (meaning no symptoms, better outcome) to 108 (feeling all of targeted symptoms every day at the most severe intensity ,worse outcome). Changes from the run - in week to end of program will be assessed.
State University of New York at Buffalo
Other
Hydration Intervention to Address Dehydration Associated With Use of GLP-1 Based Medications
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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