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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (week 0) and week 16 (post - program) |
| Change in extracellular water |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State University of New York at Buffalo, South Campus | Recruiting | Buffalo | New York | 14214 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D003924 | Diabetes Mellitus, Type 2 |
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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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.
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| Control | Behavioral | Participants randomly assigned to the control group will receive information on hydration and will receive prompts to drink. |
|
| Week -1 (run - in week) to week 16 (end of program) |
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.
| 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. | 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. | Week - 1 (run - in week) to week 16 (end of program) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D010335 | Pathologic Processes |