Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
2026년 6월 8일 업데이트: Katherine Balantekin, State University of New York at Buffalo
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.
연구 개요
연구 유형
중재적
등록 (추정된)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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New York
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Buffalo, New York, 미국, 14214
- 모병
- State University of New York at Buffalo, South Campus
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연락하다:
- Hannah E Kolpack, BS
- 전화번호: (716) 829 - 5820
- 이메일: hkolpack@buffalo.edu
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수석 연구원:
- Katherine N Balantekin, PhD, RD
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수석 연구원:
- Leonard H Epstein, PhD
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수석 연구원:
- Elizabeth G Mietlicki-Baase, PhD
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부수사관:
- Derek Daniels, PhD
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부수사관:
- Husam Ghanim, PhD
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부수사관:
- Paul Meyer, PhD
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부수사관:
- Luke Pryor, PhD, ATC, CSCS
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Control
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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Participants randomly assigned to the control group will receive information on hydration and will receive prompts to drink.
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실험적: Hydration Plus
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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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Acceptability of hydration plus
기간: At week 16, which is the end of the program.
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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).
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At week 16, which is the end of the program.
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Feasibility of Intervention
기간: At week 16, which is the end of the program.
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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).
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At week 16, which is the end of the program.
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Change in physiological hydration score
기간: Baseline (week 0) to week 16 (post - program)
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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.
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Baseline (week 0) to week 16 (post - program)
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Change in perceived hydration level
기간: Week -1 (run - in week) to week 16 (end of program)
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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.
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Week -1 (run - in week) to week 16 (end of program)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in BMI
기간: Baseline (week 0) and week 16 (post - program)
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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.
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Baseline (week 0) and week 16 (post - program)
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Change in extracellular water
기간: Baseline (week 0) and week 16 (post - program)
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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.
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Baseline (week 0) and week 16 (post - program)
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Change in intracellular water
기간: Baseline (week 0) and week 16 (post - program)
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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.
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Baseline (week 0) and week 16 (post - program)
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Changes in dehydration - associated and GLP - 1 RA - associated symptoms and symptom severity
기간: Week - 1 (run - in week) to week 16 (end of program)
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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.
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Week - 1 (run - in week) to week 16 (end of program)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Leonard H Epstein, PhD, University at Buffalo
- 수석 연구원: Katherine N Balantekin, PhD, RD, University at Buffalo
- 수석 연구원: Elizabeth G Mietlicki-Baase, PhD, University at Buffalo
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 15일
기본 완료 (추정된)
2027년 2월 1일
연구 완료 (추정된)
2027년 2월 1일
연구 등록 날짜
최초 제출
2026년 3월 25일
QC 기준을 충족하는 최초 제출
2026년 6월 8일
처음 게시됨 (실제)
2026년 6월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 8일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00009749
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .