Dehydration, Obesity & Overweight, Obesity Type 2 Diabetes Mellitus, Type 2 Diabetes, Type 2 Diabetes (Adult Onset)
Conditions
Keywords
Hydration, GLP - 1 RA, GLP - 1 RA therapy, Dehydration, Hydration biomarkers, GLP - 1 RA side effects
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.
Interventions
BEHAVIORALHydration 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.
BEHAVIORALControl
Participants randomly assigned to the control group will receive information on hydration and will receive prompts to drink.
Sponsors
State University of New York at Buffalo
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of hydration plus | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI | Baseline (week 0) and week 16 (post - program) | 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. |
| Change in extracellular water | Baseline (week 0) and week 16 (post - 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. |
| Change in intracellular water | Baseline (week 0) and week 16 (post - program) | 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. |
| Changes in dehydration - associated and GLP - 1 RA - associated symptoms and symptom severity | Week - 1 (run - in week) to week 16 (end of program) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKatherine N Balantekin, PhD, RD
University at Buffalo
PRINCIPAL_INVESTIGATORElizabeth G Mietlicki-Baase, PhD
University at Buffalo
PRINCIPAL_INVESTIGATORLeonard H Epstein, PhD
University at Buffalo
Outcome results
None listed