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Rede de Investigação de Implementação de Mudanças de Estilo de Vida no PRC da UMass Chan (LCIRN)

21 de setembro de 2026 atualizado por: Jamie Faro, University of Massachusetts, Worcester

The goal of this project is to study how well the Noom digital lifestyle program works for adults who are taking Glucagon-Like Peptide-1 receptor agonist (GLP-1) medications. The study team will assess how the program affects people's behaviors and health outcomes. The team will also look at how digital lifestyle change interventions can be implemented in real-world settings, including how many people it reaches, how well it is put into practice, whether people stick with it over time, and whether it works well for different groups of people.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

This study will examine how a digital lifestyle change program (Noom) may support adults who have recently started taking GLP-1 medications, which are commonly prescribed for weight loss and blood sugar control. The goal is to better understand how structured lifestyle guidance may improve physical activity, nutrition, and overall health while people are using these medications.

A total of 220 adults will participate in the study. Participants will be randomly assigned to one of two groups. One group will receive a four-month digital lifestyle coaching program designed to support healthy eating, physical activity, and strength-building habits. The other group will receive standard of care, a Fitbit device, resources for physical activity and nutrition, and the opportunity to participate in the lifestyle program at the completion of their 8-months in the study.

Participants will be assessed at the start of the study, after four months, and again at eight months. Throughout the study, the team will measure levels of physical activity using Fitbit devices. They will also evaluate overall diet quality using 24- hour dietary recalls of foods and beverages consumed. In addition, the team will examine other health and behavior measures, including intake of protein, fruits, and vegetables; participation in muscle-strengthening activities; confidence in maintaining healthy habits; muscle mass; body weight; waist circumference; and blood pressure.

In the 2nd Aim, the study team will evaluate implementation factors, such as how many participants were reached, how the program was implemented, engagement within the program, and how well how well the lifestyle coaching program can be delivered within real-world healthcare settings. Information will be gathered from patients, lifestyle change program leaders, healthcare providers, and healthcare systems. Data sources will include medical records, program records, and interviews.

Tipo de estudo

Intervencional

Inscrição (Estimado)

220

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.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Estados Unidos
    • Massachusetts
      • Worcester, Massachusetts, Estados Unidos, 01605
        • Recrutamento
        • UMass Chan Medical School - Shaw Building
        • Contato:

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

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Began using a GLP-1 within the past 6 months
  2. Currently using GLP-1
  3. Plans to continue GLP-1 use
  4. GLP-1 prescribed by their physician (e.g., not online or 3rd party vendor)
  5. BMI ≥27 kg/m2
  6. Age 18 years of age and older
  7. Speaks and reads English or Spanish
  8. Willing to enroll in a digital lifestyle intervention for 4-months
  9. Willing to wear a Fitbit for 8 months

Exclusion Criteria:

  1. Was taking a GLP-1 within the 2 months prior to the current GLP-1 start date
  2. Currently participating in a structured lifestyle change program (receiving structured guidance and counseling on physical activity, diet or weight loss)
  3. Currently pregnant
  4. Planning to become pregnant in the next year
  5. Active diagnosis of an eating disorder
  6. Active diagnosis of Schizophrenia or bipolar disorder
  7. Unable to walk without assistance/assistive device or have restricted walking
  8. Inability to understand the study and provide informed consent
  9. Any physical, cognitive, or psychiatric condition that poses a risk or interferes with their ability to participate at the discretion of the study PI (Co-Is: in consultation with PI or if acting as/standing in for PI)

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: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Digital Lifestyle Coaching Program

Participants randomized to the digital LCI arm will participate in a 4-month digital lifestyle intervention consisting of content modules about physical activity, nutrition, and GLP-1 support, nutrition and physical activity tracking, goal-setting, access to a health coach. They will receive a Fitbit and the same resources as the Standard of Care arm.
Outro: Digital Lifestyle Coaching Program

Participants will be enrolled for a 4-month program, in which they will use the Noom app to self-monitor their dietary intake/physical activity, be provided with coaching feedback throughout, and access educational module. Modules include behavior change specific to GLP-1, i.e. higher protein intake than what is prescribed in Noom Weight, Common challenges while taking GLP-1 medications, and weight loss medications and what to expect while taking them. They will also have access to the Muscle Defense program, which provides education on resistance training exercises to prevent muscle loss.
Sem intervenção: Standard Care

Participants in the standard of care arm will receive physical activity and nutrition resources, including those endorsed by the CDC and local resources within UMass Memorial Health and the surrounding communities, as well as Fitbit device. Upon completion of the 8-month study measures, participants will have the opportunity to participate in the 4-month digital LCI program, free of cost.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Primary Outcomes
Prazo: Baseline, 4-, and 8-months

Minutes of moderate/vigorous PA per day (over 7 days) assessed via Fitbits on days the participant has sufficient wear time, defined as >10 hours of heart rate data (accumulated of 60-second bouts).
Baseline, 4-, and 8-months
Healthy Eating Index
Prazo: Baseline, 4, and 8 months

Healthy Eating Index will be assessed via two 24-hour dietary recalls at each timepoint. The Healthy Eating Index is scored on a scale 0-100, with higher scores indicating better diet quality and alignment with the Dietary Guidelines for Americans.
Baseline, 4, and 8 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Physical Activity/Sedentary Time Metrics
Prazo: Mean counts over 7-days at baseline, 4-, and 8-months.

Objective metrics of mean step counts (steps/day), light physical activity (minutes/day), sedentary time (hours/day) over 7 days assessed via Fitbit Inspire using Fitbit algorithms and obtained through Fitabase.
Mean counts over 7-days at baseline, 4-, and 8-months.
Protein, Fruit, and Vegetable Intake
Prazo: Baseline, 4-, and 8-months

Proportion of daily intake values for each category will be assessed using two 24-hour dietary recalls.
Baseline, 4-, and 8-months
Lean Body Mass
Prazo: Baseline, 4-, and 8-months

Lean body mass will be assessed using a seca mBCA 554 bioelectrical impedance scale. The scale will obtain the results of the patient's body composition (% muscle mass, % water, % body fat, including areas of distribution).
Baseline, 4-, and 8-months
Body Weight
Prazo: Baseline, 4-, and 8-months

Body weight will be assessed via a seca mBCA 554 bioelectrical impedance scale.
Baseline, 4-, and 8-months
Blood Pressure
Prazo: Baseline, 4-, and 8-months

Three blood pressure readings will be taken 2 minutes apart after 5 minutes of rest using an automatic oscillometric device, Omron HEM-907. The average of the three readings will be recorded.
Baseline, 4-, and 8-months
Body Mass Index (BMI)
Prazo: Baseline, 4-, and 8-months

Obtained via two height measurements using a stadiometer and one weight measurement using a Seca scale, using the standard equation (Weight (lbs) x 703) / height (in)2
Baseline, 4-, and 8-months
Muscle Strengthening Activities
Prazo: Baseline, 4-, and 8-months

Assessed via self-report using the Muscle Strengthening Exercise Questionnaire Short Form, a scale assessing key dimensions of muscle-strengthening exercise, including frequency, session duration, intensity, exercise type, and muscle groups targeted
Baseline, 4-, and 8-months
Physical Activity Self-Efficacy
Prazo: Baseline, 4-, and 8-months

A self-report assessment using the Self-efficacy for Physical Activity Scale, a 5-question scale assessing how confident a person is that they could be physically active in certain situations
Baseline, 4-, and 8-months
Physical Activity Motivation
Prazo: Baseline, 4-, and 8-months

A self-report assessment using the 1 question Readiness to Change for Physical Activity, which assess a person's current physical activity habits and readiness to change.
Baseline, 4-, and 8-months
Healthy Eating Self-Efficacy
Prazo: Baseline, 4-, and 8-months

A self-report assessment using the Eating and Weight Self-efficacy Scale, a 7-question scale assessing a person's confidence to eat healthy in certain situations
Baseline, 4-, and 8-months
Healthy Eating Motivation
Prazo: Baseline, 4-, and 8-months

A self-report assessment using the 1 question Readiness to Change for Healthy Eating, which assess a person's current eating habits and readiness to change
Baseline, 4-, and 8-months
Global Physical Health
Prazo: Baseline, 4-, and 8-months

Physical health will be assessed using the PROMIS Global Physical Health, consisting of 4 questions asking about overall health, physical function, pain, and fatigue using Likert scale responses
Baseline, 4-, and 8-months
Intervention Acceptability
Prazo: 4-months in Intervention group only

The Theoretical Framework of Acceptability (TFA) is an 8-item questionnaire that can be adapted to an intervention to assess the acceptability of healthcare interventions using a Likert scale of 1 to 5 (higher scores indicating greater acceptability).
4-months in Intervention group only

Colaboradores e Investigadores

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

Patrocinador

University of Massachusetts, Worcester

Colaboradores

Centers for Disease Control and Prevention
University of Massachusetts, Lowell

Investigadores

  • Investigador principal: Jamie Faro, PhD, UMass Chan Medical School

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 (Real)

22 de julho de 2026

Conclusão Primária (Estimado)

30 de abril de 2029

Conclusão do estudo (Estimado)

29 de setembro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

13 de março de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de março de 2026

Primeira postagem (Real)

18 de março de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • STUDY00002809
  • U48DP006955 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Participant survey data and participant physiologic data will be shared. This includes a complete, de-identified data set, including survey and clinical/physiologic data (and relevant R or SAS code) through DKnet, the Inter-University Consortium for Political and Social Research, or eScholarship@UMassChan.

Prazo de Compartilhamento de IPD

IPD and supporting information will become available at time of primary results publication.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF

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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