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

NCT07641361 | Recruiting

• 1 other identifier: STUDY00009749
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Acceptability of hydration plus

  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).

  At week 16, which is the end of the program.

• Feasibility of Intervention

  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).

  At week 16, which is the end of the program.

• Change in physiological hydration score

  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.

  Baseline (week 0) to week 16 (post - program)

• Change in perceived hydration level

  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.

  Week -1 (run - in week) to week 16 (end of program)

Secondary Outcomes (4)

• Change in BMI

  Baseline (week 0) and week 16 (post - program)

• Change in extracellular water

  Baseline (week 0) and week 16 (post - program)

• Change in intracellular water

  Baseline (week 0) and week 16 (post - program)

• Changes in dehydration - associated and GLP - 1 RA - associated symptoms and symptom severity

  Week - 1 (run - in week) to week 16 (end of program)

Study Arms (2)

Control

ACTIVE COMPARATOR

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.

Behavioral: Control

Hydration Plus

EXPERIMENTAL

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.

Behavioral: Hydration Plus

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.

Hydration Plus

Control BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18-60
• Recently prescribed a GLP-1RA (within one week of prescription)
• Fluent in English
• Willing to complete the study protocol

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

State University of New York at Buffalo, South Campus

Buffalo, New York, 14214, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Diabetes Mellitus, Type 2; Dehydration

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Water-Electrolyte Imbalance; Pathologic Processes

Study Officials

• Katherine N Balantekin, PhD, RD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

• Elizabeth G Mietlicki-Baase, PhD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

• Leonard H Epstein, PhD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to either the control group or the hydration plus (experimental) group. 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. The control group will not engage in those behavior change strategies listed prior, but will receive the same information and complete all of the same daily and weekly tasks.

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: June 11, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

US (1)