Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
2026年6月8日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
30
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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New York
-
Buffalo、New York、アメリカ、14214
- 募集
- State University of New York at Buffalo, South Campus
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コンタクト：
- Hannah E Kolpack, BS
- 電話番号：(716) 829 - 5820
- メール：hkolpack@buffalo.edu
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主任研究者：
- Katherine N Balantekin, PhD, RD
-
主任研究者：
- Leonard H Epstein, PhD
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主任研究者：
- Elizabeth G Mietlicki-Baase, PhD
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副調査官：
- Derek Daniels, PhD
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副調査官：
- Husam Ghanim, PhD
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副調査官：
- Paul Meyer, PhD
-
副調査官：
- Luke Pryor, PhD, ATC, CSCS
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acceptability of hydration plus
時間枠：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).
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At week 16, which is the end of the program.
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Feasibility of Intervention
時間枠：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
時間枠：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.
|
Baseline (week 0) to week 16 (post - program)
|
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Change in perceived hydration level
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in BMI
時間枠：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.
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Baseline (week 0) and week 16 (post - program)
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Change in extracellular water
時間枠：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
時間枠：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.
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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
時間枠：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)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Leonard H Epstein, PhD、University at Buffalo
- 主任研究者：Katherine N Balantekin, PhD, RD、University at Buffalo
- 主任研究者：Elizabeth G Mietlicki-Baase, PhD、University at Buffalo
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月15日
一次修了 (推定)
2027年2月1日
研究の完了 (推定)
2027年2月1日
試験登録日
最初に提出
2026年3月25日
QC基準を満たした最初の提出物
2026年6月8日
最初の投稿 (実際)
2026年6月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月11日
QC基準を満たした最後の更新が送信されました
2026年6月8日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00009749
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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