Recruiting

GLP-1 RA

Sponsor:

State University of New York at Buffalo

Code:

NCT07641361

Conditions

Obesity & Overweight

Type 2 Diabetes

Type 2 Diabetes (Adult Onset)

Obesity Type 2 Diabetes Mellitus

Dehydration

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Hydration Plus

Control

Study Details

Brief 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

Study ID

NCT07641361

Start date

Jun 15, 2026

Status verified date

Jun, 2026

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Control

Participants randomly assigned to the control group will receive information on hydration and will receive prompts to drink.

Primary outcome measure

  • Acceptability of hydration plus [ Time Frame: At week 16, which is the end of the program. ]
  • Feasibility of Intervention [ Time Frame: At week 16, which is the end of the program. ]
  • Change in physiological hydration score [ Time Frame: Baseline (week 0) to week 16 (post - program) ]
  • Change in perceived hydration level [ Time Frame: Week -1 (run - in week) to week 16 (end of program) ]

Central Contacts and Locations

Locations

State University of New York at Buffalo, South Campus

Recruiting

Buffalo, New York, United States, 14214

Contacts

Hannah E Kolpack, BS

(716) 829 - 5820hkolpack@buffalo.edu

Principal Investigator:

Katherine N Balantekin, PhD, RD

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • Hydration
  • GLP - 1 RA
  • GLP - 1 RA therapy
  • Dehydration
  • Hydration biomarkers
  • GLP - 1 RA side effects

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-06-11.