- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07481305
Red de Investigación sobre la Implementación de Cambios en el Estilo de Vida en PRC de UMass Chan (LCIRN)
Red de Investigación sobre Implementación de Cambios en el Estilo de Vida en el PRC de UMass Chan
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Reem Y Najjar, BS
- Número de teléfono: 774-275-0890
- Correo electrónico: Reem.Najjar@umassmed.edu
Copia de seguridad de contactos de estudio
- Nombre: Joann Wagner, MSW
- Número de teléfono: 508-856-6944
- Correo electrónico: joann.wagner@umassmed.edu
Ubicaciones de estudio
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Massachusetts
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Worcester, Massachusetts, Estados Unidos, 01605
- Reclutamiento
- UMass Chan Medical School - Shaw Building
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Contacto:
- Jamie Faro, PhD
- Número de teléfono: 617-828-8093
- Correo electrónico: jamie.faro@umassmed.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Began using a GLP-1 within the past 6 months
- Currently using GLP-1
- Plans to continue GLP-1 use
- GLP-1 prescribed by their physician (e.g., not online or 3rd party vendor)
- BMI ≥27 kg/m2
- Age 18 years of age and older
- Speaks and reads English or Spanish
- Willing to enroll in a digital lifestyle intervention for 4-months
- Willing to wear a Fitbit for 8 months
Exclusion Criteria:
- Was taking a GLP-1 within the 2 months prior to the current GLP-1 start date
- Currently participating in a structured lifestyle change program (receiving structured guidance and counseling on physical activity, diet or weight loss)
- Currently pregnant
- Planning to become pregnant in the next year
- Active diagnosis of an eating disorder
- Active diagnosis of Schizophrenia or bipolar disorder
- Unable to walk without assistance/assistive device or have restricted walking
- Inability to understand the study and provide informed consent
- 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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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. |
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. |
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Sin intervención: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Primary Outcomes
Periodo de tiempo: 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
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Healthy Eating Index
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Physical Activity/Sedentary Time Metrics
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
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|
Body Weight
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
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Muscle Strengthening Activities
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
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|
Global Physical Health
Periodo de tiempo: 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
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Intervention Acceptability
Periodo de tiempo: 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
Patrocinador
Investigadores
- Investigador principal: Jamie Faro, PhD, UMass Chan Medical School
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00002809
- U48DP006955 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Marco de tiempo para compartir IPD
IPD and supporting information will become available at time of primary results publication.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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