An Online Lifestyle Program With an AI Lifestyle Coach and Continues Glucose Monitoring in Type 2 Diabetes. (PREVAIL)
"An Online Personalised Lifestyle Program With a Virtual AI Lifestyle Coach in Combination With Continues Glucose Monitoring for People With Type 2 Diabetes."
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Rationale: An estimated 400,000 individuals in the Netherlands are living with undiagnosed type 2 diabetes (T2D), in addition to 1.1 million diagnosed cases. Unhealthy lifestyle behaviours are a major contributing factor. Intensive lifestyle interventions and Continuous Glucose Monitoring (CGM) have demonstrated effectiveness in improving health behaviour and glycaemic control. Digital health technologies, including personalised digital interventions and virtual coaching enable continuous, scalable and context-specific support, thereby facilitating sustained behaviour change and improved self-management. Remote lifestyle interventions are therefore promising and may enhance self-management and glycaemic control, reduce medicine use and delay the development of comorbidities and diabetes-related complications. This study evaluates a remote, personalised lifestyle program combining online group sessions, peer support, CGM use, and a virtual AI lifestyle coach for individuals living with T2D.
Objective: The objective of this study is to evaluate the added value of CGM, biofeedback and a virtual AI lifestyle coach providing personalised, data-driven support within a first prototype of a remote lifestyle intervention for adults with T2D. Specifically, this pilot randomized controlled trial aims to assess the incremental effects of CGM, biofeedback and AI supported personalised coaching, informed by glucose data, demographics, behaviour, goals and preferences on health behaviours and glycaemic control over a 12-month period with two follow-up measurements.
Study design: This three-arm parallel-group randomized controlled trial includes:
- A lifestyle program consisting of online group sessions and a peer support community.
- The same lifestyle program supplemented with a virtual AI lifestyle coach.
- The AI-supported program with four times CGM use.
Study population: Adults (n=160) with T2D (HbA1c ≥53 mmol/mol) without glucose lowering medication (except Metformin), both men and women from all ethnic backgrounds.
Intervention: Participants complete an online baseline questionnaire and a brief in-app intake prior to randomization. All participants attend online group sessions and may engage with peers via the online community. The AI lifestyle coach uses the baseline data to have personalised coaching conversations with the participant throughout the intervention. In the third arm, real-time CGM data are additionally integrated into the AI-driven personalisation process.
Main study parameters/endpoints: The primary outcome is change in HbA1c from baseline to 12 months. Secondary outcomes include changes in physiological (e.g. body weight), clinical (e.g. time in range), behavioural (e.g. dietary intake), and psychological (e.g. quality of life) outcomes.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Lotte G.P. Peters, MSc
- Número de teléfono: +31534891403
- Correo electrónico: lotte.peters@utwente.nl
Copia de seguridad de contactos de estudio
- Nombre: Anouk Middelweerd, Dr
- Número de teléfono: +31534897486
- Correo electrónico: a.middelweerd@utwente.nl
Ubicaciones de estudio
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Overijssel
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Enschede, Overijssel, Países Bajos, 7500 AE
- University of Twente
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Contacto:
- Lotte G.P. Peters, MSc
- Número de teléfono: +31534891403
- Correo electrónico: lotte.peters@utwente.nl
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Investigador principal:
- Lotte G.P. Peters, MSc
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age: ≥18 years
- HbA1c: ≥53 mmol/mol (7 - 12%)
- Signed informed consent form and willing to comply with the study procedures
- Persons who are naïve for participation in a lifestyle program for the past two years
- Being digitally competent
- Mastering the Dutch language
- Accepting the confidential use and storage of anonymised data for analysis and publication (at least 15 years)
Exclusion Criteria:
- Medication use: any other glucose-lowering medication than metformin
- Comorbidities or medical conditions requiring a special diet that conflicts with the study
- Unstable body weight in the three months prior to inclusion in the study (±5% change based on body weight)
- Circumstances that lead to unreliable HbA1c values, such as blood donation
- Pregnant or lactating women
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 |
|---|---|
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Comparador activo: Arm 1
Lifestyle program (control group)
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Participants are asked to work on improving their lifestyle.
They have access to an online community throughout the study, where they can get in touch with other participants within their research-arm.
Participants are also asked to attend twelve online group sessions, during which a lifestyle coach will explain more about nutrition, physical activity, sleep, stress, social aspects, challenges and setbacks, and long-term maintenance.
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Experimental: Arm 2
Lifestyle program + coach
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Idem to arm one, supplemented with a virtual AI lifestyle coach.
The AI lifestyle coach can process all the information about the participant that was provided at baseline.
This information is compiled into a participant profile, which the AI lifestyle coach uses to initiate personalised conversations with the participant.
During these conversations, the AI lifestyle coach supports the participant through a structured coaching cycle of three phases: preparation (reflecting on what matters and co-creating a personalised plan), coaching (day-to-day support to work on the plan), and evaluation (reviewing progress and adjusting or renewing the plan).
The coach draws on an evidence-based knowledge base of lifestyle interventions to recommend appropriate, evidence-informed actions.
The use of the AI lifestyle coach is an additional topic to the online group sessions.
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Experimental: Arm 3
Lifestyle program + coach + CGM
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Idem to arm two, but participants are also asked to wear an CGM four times for two consecutive weeks.
The glucose values information collected by the CGM is used by the AI lifestyle coach to make conversations with the participant even more personalized.
The use of CGMs is an additional topic to the online group sessions.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in HbA1c levels
Periodo de tiempo: From the beginning of the study to the end of the study at 12 months
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The main study parameter is the impact of the lifestyle program on blood glucose levels, as evaluated by changes in HbA1c levels at the beginning of the study and after 3, 6 and 12 months.
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From the beginning of the study to the end of the study at 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in body weight
Periodo de tiempo: From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
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From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
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Change in medication use
Periodo de tiempo: From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
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From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
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Change in waist and hip circumference
Periodo de tiempo: From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
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From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
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Change in albumin-creatinine ratio
Periodo de tiempo: From the beginning of the study to the end of the study (12 months)
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Urine sample
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From the beginning of the study to the end of the study (12 months)
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Change in blood pressure
Periodo de tiempo: From the beginning of the study to the end of the study (12 months)
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Systolic and diastolic blood pressure
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From the beginning of the study to the end of the study (12 months)
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Change in habitual dietary intake assessed with the Nutri+ instrument
Periodo de tiempo: From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
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From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
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Change in glycaemic regulation assessed with CGM and blood sample
Periodo de tiempo: From the beginning of the study to the end of the study (12 months)
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From the beginning of the study to the end of the study (12 months)
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Study evaluation
Periodo de tiempo: Once at the end of the study at 12 months
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Dutch System Usability Scale (SUS).
Ten questions on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree).
Higher scores indicate greater overall usability of the system being studied.
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Once at the end of the study at 12 months
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Tailoring
Periodo de tiempo: Once at the end of the study at 12 months
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Success in Tailoring (SIT) scale.
Eight items on a 5-point Likert-scale (1 = strongly disagree to 5 = strongly agree).
Higher scores indicate greater perceived individual tailoring of the information.
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Once at the end of the study at 12 months
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Change in quality of life
Periodo de tiempo: At the start of the study and at the two follow-up measurements at 18 and 24 months
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Health-related quality of life (EQ-5D).
It assigns a score across five health dimensions, from "I have no problems..." to "I am unable to...".
The higher the score, the better the quality of life.
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At the start of the study and at the two follow-up measurements at 18 and 24 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Socio-demographic characteristics
Periodo de tiempo: At baseline
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Socio-demographic characteristics obtained with the baseline questionnaire.
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At baseline
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Goos D. Laverman, Prof. Dr., University of Twente
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
- Enfermedades del sistema endocrino
- Enfermedades metabólicas
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Enfermedades Nutricionales y Metabólicas
- Diabetes Mellitus, Tipo 2
- Técnicas de investigación
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Análisis de químicos de sangre
- Pruebas de química clínica
- Técnicas de diagnóstico, endocrino
- Monitoreo, fisiológico
- Monitoreo continuo de glucosa
Otros números de identificación del estudio
- NL011950 (Otro identificador: Central Committee on Research Involving Human Subjects)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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