Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hydration Plus, Control.
- Who it may be relevant to
- Registry conditions: Obesity & Overweight, Type 2 Diabetes, Type 2 Diabetes (Adult Onset), Obesity Type 2 Diabetes Mellitus. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Hydration Intervention to Address Dehydration Associated With Use of GLP-1 Based Medications
Overview
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.
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.
Primary outcome measures
- 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)]
Secondary outcome measures (4)
- Change in BMI [Time frame: Baseline (week 0) and week 16 (post - program)]
- Change in extracellular water [Time frame: Baseline (week 0) and week 16 (post - program)]
- Change in intracellular water [Time frame: Baseline (week 0) and week 16 (post - program)]
- Changes in dehydration - associated and GLP - 1 RA - associated symptoms and symptom severity [Time frame: Week - 1 (run - in week) to week 16 (end of program)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- State University of New York at Buffalo, South Campus — Buffalo
Identifiers
NCT: NCT07641361 · STUDY00009749