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Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy

8 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

30

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • New York
      • Buffalo, New York, Estados Unidos, 14214
        • Recrutamento
        • State University of New York at Buffalo, South Campus
        • Contato:
        • Investigador principal:
          • Katherine N Balantekin, PhD, RD
        • Investigador principal:
          • Leonard H Epstein, PhD
        • Investigador principal:
          • Elizabeth G Mietlicki-Baase, PhD
        • Subinvestigador:
          • Derek Daniels, PhD
        • Subinvestigador:
          • Husam Ghanim, PhD
        • Subinvestigador:
          • Paul Meyer, PhD
        • Subinvestigador:
          • Luke Pryor, PhD, ATC, CSCS

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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.
Comportamental: Control
Participants randomly assigned to the control group will receive information on hydration and will receive prompts to drink.
Experimental: 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.
Comportamental: Hydration 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Acceptability of hydration plus
Prazo: 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).
At week 16, which is the end of the program.
Feasibility of Intervention
Prazo: 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).
At week 16, which is the end of the program.
Change in physiological hydration score
Prazo: 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.
Baseline (week 0) to week 16 (post - program)
Change in perceived hydration level
Prazo: 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.
Week -1 (run - in week) to week 16 (end of program)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in BMI
Prazo: 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.
Baseline (week 0) and week 16 (post - program)
Change in extracellular water
Prazo: 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.
Baseline (week 0) and week 16 (post - program)
Change in intracellular water
Prazo: 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.
Baseline (week 0) and week 16 (post - program)
Changes in dehydration - associated and GLP - 1 RA - associated symptoms and symptom severity
Prazo: 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.
Week - 1 (run - in week) to week 16 (end of program)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

State University of New York at Buffalo

Colaboradores

National Institutes of Health (NIH)

Investigadores

  • Investigador principal: Leonard H Epstein, PhD, University at Buffalo
  • Investigador principal: Katherine N Balantekin, PhD, RD, University at Buffalo
  • Investigador principal: Elizabeth G Mietlicki-Baase, PhD, University at Buffalo

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de junho de 2026

Conclusão Primária (Estimado)

1 de fevereiro de 2027

Conclusão do estudo (Estimado)

1 de fevereiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

25 de março de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de junho de 2026

Primeira postagem (Real)

11 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • STUDY00009749

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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