[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07641361":3,"trial-entities:NCT07641361":138,"trial-summary:NCT07641361":143},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":47,"secondary_outcomes":63,"sex":78,"minimum_age":79,"maximum_age":80,"healthy_volunteers":15,"eligibility_criteria":81,"std_ages":96,"locations":98,"central_contacts":130,"overall_officials":131,"references":136,"see_also_links":137},"NCT07641361","STUDY00009749","Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy","Hydration Intervention to Address Dehydration Associated With Use of GLP-1 Based Medications","RECRUITING","2027-02-01","2026-06","2026-06-11","2026-06-15","State University of New York at Buffalo","OTHER",false,"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.",null,[19,20,21,22,23],"Obesity & Overweight","Type 2 Diabetes","Type 2 Diabetes (Adult Onset)","Obesity Type 2 Diabetes Mellitus","Dehydration",[25,26,27,23,28,29],"Hydration","GLP - 1 RA","GLP - 1 RA therapy","Hydration biomarkers","GLP - 1 RA side effects","INTERVENTIONAL","TREATMENT",[33],"NA",{"count":35,"type":36},30,"ESTIMATED",[38,43],{"type":39,"name":40,"description":41,"armGroupLabels":42},"BEHAVIORAL","Hydration Plus","The hydration plus intervention aims to increase hydration through employing the following behavior change strategies\u002Ftechniques: 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.",[40],{"type":39,"name":44,"description":45,"armGroupLabels":46},"Control","Participants randomly assigned to the control group will receive information on hydration and will receive prompts to drink.",[44],[48,52,55,59],{"measure":49,"description":50,"timeFrame":51},"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.",{"measure":53,"description":54,"timeFrame":51},"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).",{"measure":56,"description":57,"timeFrame":58},"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)",{"measure":60,"description":61,"timeFrame":62},"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.","Week -1 (run - in week) to week 16 (end of program)",[64,68,71,74],{"measure":65,"description":66,"timeFrame":67},"Change in BMI","BMI will be calculated using laboratory - measured weight and height and reported in kg\u002Fm\\^2. Changes from baseline to end of program will be assessed.","Baseline (week 0) and week 16 (post - program)",{"measure":69,"description":70,"timeFrame":67},"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.",{"measure":72,"description":73,"timeFrame":67},"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.",{"measure":75,"description":76,"timeFrame":77},"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)","ALL","18 Years","60 Years",{"inclusion":82,"exclusion":87,"raw_text":95},[83,84,85,86],"Adults aged 18-60","Recently prescribed a GLP-1RA (within one week of prescription)","Fluent in English","Willing to complete the study protocol",[88,89,90,91,92,93,94],"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","Inclusion Criteria:\n\n* Adults aged 18-60\n* Recently prescribed a GLP-1RA (within one week of prescription)\n* Fluent in English\n* Willing to complete the study protocol\n\nExclusion Criteria:\n\n* Children and adults \\> 60 years of age\n* Those not taking a GLP-1RA\n* Those who have been on a GLP-1RA longer than one week\n* Not fluent in English\n* Those who are pregnant or planning on becoming pregnant during the duration of the study\n* Unwilling to comply with study protocol\n* People with cardiac implants",[97],"ADULT",[99],{"facility":100,"status":8,"city":101,"state":102,"zip":103,"country":104,"contacts":105,"geoPoint":127},"State University of New York at Buffalo, South Campus","Buffalo","New York","14214","United States",[106,111,114,116,118,121,123,125],{"name":107,"role":108,"phone":109,"email":110},"Hannah E Kolpack, BS","CONTACT","(716) 829 - 5820","hkolpack@buffalo.edu",{"name":112,"role":113},"Katherine N Balantekin, PhD, RD","PRINCIPAL_INVESTIGATOR",{"name":115,"role":113},"Elizabeth G Mietlicki-Baase, PhD",{"name":117,"role":113},"Leonard H Epstein, PhD",{"name":119,"role":120},"Derek Daniels, PhD","SUB_INVESTIGATOR",{"name":122,"role":120},"Husam Ghanim, PhD",{"name":124,"role":120},"Paul Meyer, PhD",{"name":126,"role":120},"Luke Pryor, PhD, ATC, CSCS",{"lat":128,"lon":129},42.88645,-78.87837,[],[132,134,135],{"name":112,"affiliation":133,"role":113},"University at Buffalo",{"name":115,"affiliation":133,"role":113},{"name":117,"affiliation":133,"role":113},[],[],{"nct_id":4,"conditions":139,"biomarkers":142},[140,141],"Obesity","Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]