An interventional study of Hydration Plus and Control in Obesity & Overweight, Type 2 Diabetes and Type 2 Diabetes (Adult Onset), sponsored by State University of New York at Buffalo. Recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Treatment
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 30 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →State University of New York at Buffalo is the lead sponsor of 294 studies on the registry; 63 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
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Exclusion Criteria:
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
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
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.
Participants randomly assigned to the control group will receive information on hydration and will receive prompts to drink.
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Week -1 (run - in week) to week 16 (end of program)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week - 1 (run - in week) to week 16 (end of program)
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Feb 2027, 4 months after the start.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 4 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
Start moved once since we started tracking on Sep 25, 2026: Jun 2026 → Sep 2026, on Oct 2, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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