Obesity & OverweightNCT07641361
Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
A study testing Hydration Plus in people with Obesity & Overweight and Type 2 Diabetes, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity & Overweight, Type 2 Diabetes, Type 2 Diabetes (Adult Onset)
- What is being tested?
- Hydration Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-60
- Recently prescribed a GLP-1RA (within one week of prescription)
- Fluent in English
- Willing to complete the study protocol
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
State University of New York at Buffalo, South Campus
Buffalo, New York, 14214
Hannah E Kolpack, BS, (716) 829 - 5820, hkolpack@buffalo.edu
Katherine N Balantekin, PhD, RD
About this study
Official title: Hydration Intervention to Address Dehydration Associated With Use of GLP-1 Based Medications
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
- Being tested
- Hydration Plus, Control
- Keywords
- Hydration, GLP - 1 RA, GLP - 1 RA therapy, Dehydration, Hydration biomarkers, GLP - 1 RA side effects
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Type 2, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydration PlusBehavioural
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.
ControlBehavioural
Participants randomly assigned to the control group will receive information on hydration and will receive prompts to drink.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Hydration Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Week -1 (run - in week) to week 16 (end of program)
Secondary outcomes (4)
Change in BMI
BMI will be calculated using laboratory - measured weight and height and reported in kg/m^2. Changes from baseline to end of program will be assessed.
Measured: Baseline (week 0) and week 16 (post - program)
Change in extracellular water
Extracellular water will be measured using a bioelectrical impedance analysis (BIA). BIA consists of a painless, low - intensity electrical current being sent through the body and measuring resistance (impedance) to provide body composition information. Changes from baseline to end of program will be assessed.
Measured: Baseline (week 0) and week 16 (post - program)
Change in intracellular water
Change in intracellular water will be measured using a bioelectrical impedance analysis (BIA). BIA consists of a painless, low - intensity electrical current being sent through the body and measuring resistance (impedance) to assess various measures of body composition. Changes from baseline to end of program will be assessed.
Measured: Baseline (week 0) and week 16 (post - program)
Changes in dehydration - associated and GLP - 1 RA - associated symptoms and symptom severity
Severity and amount of side effects of GLP - 1 RA's will be measured using a questionnaire that assesses the side effect symptoms and symptom severity an individual experiences while being on a GLP - 1 RA. Scores can range from 0 (meaning no symptoms, better outcome) to 108 (feeling all of targeted symptoms every day at the most severe intensity ,worse outcome). Changes from the run - in week to end of program will be assessed.
Measured: Week - 1 (run - in week) to week 16 (end of program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start24 Sep 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Katherine Balantekin, State University of New York at Buffalo
- Investigators
- Katherine N Balantekin, PhD, RD, Principal investigator, University at BuffaloElizabeth G Mietlicki-Baase, PhD, Principal investigator, University at BuffaloLeonard H Epstein, PhD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641361
- Sponsor's protocol ID
- STUDY00009749
- Status last verified
- Jun 2026
- First submitted
- 25 Mar 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydration Intervention to Address Dehydration Associated With Use of GLP-1 Based Medications
- ClinicalTrials.gov ID
- NCT07641361
- Acronym / sponsor ID
- STUDY00009749
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 24 Sep 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: ControlParticipants 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. |
| Hydration Plus | Experimental | Behavioral: Hydration PlusThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 18-60
- Recently prescribed a GLP-1RA (within one week of prescription)
- Fluent in English
- Willing to complete the study protocol
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydration PlusThe 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. | Behavioural | Hydration Plus |
| ControlParticipants randomly assigned to the control group will receive information on hydration and will receive prompts to drink. | Behavioural | Control |
Primary outcome
Acceptability of hydration plus
Time frame: At week 16, which is the end of the program.
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).
Feasibility of Intervention
Time frame: At week 16, which is the end of the program.
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).
Change in physiological hydration score
Time frame: Baseline (week 0) to week 16 (post - program)
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.
Change in perceived hydration level
Time frame: Week -1 (run - in week) to week 16 (end of program)
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.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
State University of New York at Buffalo, South Campus
Buffalo, United States
Katherine N Balantekin, PhD, RD principal investigator
University at Buffalo
Elizabeth G Mietlicki-Baase, PhD principal investigator
University at Buffalo
Leonard H Epstein, PhD principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydration Plus in people with Obesity & Overweight and Type 2 Diabetes, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of hydration plus (time frame: At week 16, which is the end of the program.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.