Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
NCT07641361 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-06-11
Summary
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.
Conditions
- Obesity & Overweight
- Type 2 Diabetes
- Type 2 Diabetes (Adult Onset)
- Obesity Type 2 Diabetes Mellitus
- Dehydration
Interventions
- BEHAVIORAL
-
Hydration Plus
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.
- BEHAVIORAL
-
Control
Participants randomly assigned to the control group will receive information on hydration and will receive prompts to drink.
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH -
State University of New York at Buffalo
lead OTHER
Principal Investigators
-
Katherine N Balantekin, PhD, RD · University at Buffalo
-
Elizabeth G Mietlicki-Baase, PhD · University at Buffalo
-
Leonard H Epstein, PhD · University at Buffalo
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-15
- Primary Completion
- 2027-02-01
- Completion
- 2027-02-01
Countries
- United States
Study Locations
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