Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy

Part of paid clinical trials in Buffalo, New York.

Sponsor
State University of New York at Buffalo
Study ID
NCT07641361
Status
Recruiting
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Conditions

  • Dehydration
  • Obesity & Overweight
  • Obesity Type 2 Diabetes Mellitus
  • Type 2 Diabetes
  • Type 2 Diabetes (Adult Onset)

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Hydration Plus — BEHAVIORAL
    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.
  • Control — BEHAVIORAL
    Participants randomly assigned to the control group will receive information on hydration and will receive prompts to drink.

Study Details

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.

Key Dates

Start date
Jun 15, 2026
Status verified
Jun 2026
Primary completion
Feb 1, 2027
Completion
Feb 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control
    Participants assigned to the control group will receive all information as the Hydration Plus (experimental) group, but will not receive any behavior change strategies or technique training/materials.
  • Experimental: Hydration Plus
    The hydration plus group will receive the following behavior change strategies/techniques: coaching (consisting of goal setting, making a plan, and coping planning), positive feedback, and follow a contingency management payment schedule.

Primary Outcome Measure

Acceptability of hydration plus [ Time Frame: At week 16, which is the end of the program. ]

Locations (1)

FacilityCityStateZIPSite coordinators
State University of New York at Buffalo, South CampusBuffaloNew York14214
Hannah E Kolpack, BS
[email protected]
(716) 829 - 5820
Katherine N Balantekin, PhD, RD (PRINCIPAL_INVESTIGATOR)
Elizabeth G Mietlicki-Baase, PhD (PRINCIPAL_INVESTIGATOR)
Leonard H Epstein, PhD (PRINCIPAL_INVESTIGATOR)
Derek Daniels, PhD (SUB_INVESTIGATOR)
Husam Ghanim, PhD (SUB_INVESTIGATOR)
Paul Meyer, PhD (SUB_INVESTIGATOR)
Luke Pryor, PhD, ATC, CSCS (SUB_INVESTIGATOR)

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By research site
State University of New York at Buffalo, South Campus· Buffalo, NY

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