RecruitingRecruiting
Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
NCT07641361 · State University of New York at Buffalo
In plain English
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Official title
Hydration Intervention to Address Dehydration Associated With Use of GLP-1 Based Medications
About this study
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.
Eligibility criteria
Inclusion Criteria:
* Adults aged 18-60
* Recently prescribed a GLP-1RA (within one week of prescription)
* Fluent in English
* Willing to complete the study protocol
Exclusion Criteria:
* Children and adults \> 60 years of age
* Those not taking a GLP-1RA
* Those who have been on a GLP-1RA longer than one week
* Not fluent in English
* Those who are pregnant or planning on becoming pregnant during the duration of the study
* Unwilling to comply with study protocol
* People with cardiac implants
Study design
Enrollment target: 30 participants
Allocation: randomized
Masking: single
Age groups: adult
Timeline
Starts: 2026-06-15
Estimated completion: 2027-02-01
Last updated: 2026-06-11
Interventions
Behavioral: Hydration PlusBehavioral: Control
Primary outcomes
- • Acceptability of hydration plus (At week 16, which is the end of the program.)
- • Feasibility of Intervention (At week 16, which is the end of the program.)
- • Change in physiological hydration score (Baseline (week 0) to week 16 (post - program))
Sponsor
State University of New York at Buffalo · other
With: National Institutes of Health (NIH)
Contacts & investigators
InvestigatorKatherine N Balantekin, PhD, RD · principal_investigator, University at Buffalo
InvestigatorElizabeth G Mietlicki-Baase, PhD · principal_investigator, University at Buffalo
InvestigatorLeonard H Epstein, PhD · principal_investigator, University at Buffalo
All locations (1)
State University of New York at Buffalo, South CampusRecruiting
Buffalo, New York, United States