Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Roybal Via Habit Formation (Via Habit)

23 de septiembre de 2026 actualizado por: Shiyu Li, PhD, Louisiana State University and A&M College

Automata Modeling Approach to Identify and Pilot-Test Receptive Windows for Physical Activity Habit Formation in Midlife Adults

This pilot study will develop and evaluate ViaHabit, a personalized walking intervention designed to promote physical activity habit formation among sedentary midlife adults (ages 45-65). During an initial 2-week observation period, participants' daily routines will be characterized using data collected from wearable devices, smartphones, and digital calendars. Personalized models will identify routine transitions, defined as periods between everyday activities, that may serve as receptive opportunities for initiating physical activity. Participants will then complete a 4-week intervention in which they create individualized "if-then" action plans linking routine transitions to a 15-minute brisk walk and receive automated smartwatch prompts at selected cue times. The study will assess the feasibility and acceptability of identifying routine transitions and delivering timely physical activity prompts, while exploring changes in walking behavior, habit strength, and physical activity engagement.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

This pilot study will develop and evaluate ViaHabit, a personalized, cue-based walking intervention designed to promote physical activity habit formation among sedentary midlife adults. The study is based on the premise that routine transitions, defined as periods when one daily activity has ended and another has not yet begun, may represent receptive opportunities for initiating new health behaviors. The long-term goal is to increase physical activity during midlife, a critical period for reducing risk factors associated with cognitive decline and dementia.

The study will enroll approximately 10 adults aged 45 to 65 years who are physically inactive and experience competing work, caregiving, parenting, or other role demands. Participants must own or be willing to use an iPhone-compatible device and be able to walk without assistance.

The study uses a 12-week, single-arm, within-subject design consisting of two phases. During Phase 1 (2-week observation period), participants will use an Apple Watch, smartphone applications, and digital calendar tools to collect multimodal data on daily behavior, including physical activity, location patterns, calendar events, and contextual information. These data will be used to develop individualized computational models of participants' daily routines and identify recurring routine transitions that may serve as effective cues for physical activity initiation.

Following model development, participants will enter Phase 2 (4-week intervention period). In a virtual coaching session, participants will identify up to two routine transitions that can function as cues for walking and will create personalized "if-then" action plans linking those cues to a 15-minute brisk walk. Automated smartwatch notifications will be delivered when the selected routine transitions occur to increase cue salience and support initiation of physical activity. Walking behavior will be continuously monitored through wearable devices.

The primary objectives are to evaluate the feasibility of identifying individualized routine transitions from passive sensing data and the feasibility and acceptability of delivering a personalized, cue-based walking intervention anchored to those transitions. Secondary and exploratory outcomes include adherence to study procedures, walking behavior, cue-triggered behavioral enactment, habit strength, physical activity levels, and cognitive function. Habit strength will be assessed using measures of behavioral automaticity, while cognitive function will be evaluated through mobile cognitive assessments administered during the intervention period.

The findings will inform the development of scalable, data-driven interventions that leverage naturally occurring daily routines to support physical activity habit formation and healthy aging.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

10

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Shiyu Li, PhD
  • Número de teléfono: 225-578-0977
  • Correo electrónico: sli40@lsu.edu

Copia de seguridad de contactos de estudio

  • Nombre: Kimberly Allen, MA
  • Número de teléfono: 225-578-2363

Ubicaciones de estudio

    • Louisiana
      • Baton Rouge, Louisiana, Estados Unidos, 70803
        • Louisiana State University School of Kinesiology

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

45 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Age 45 to 65 years.
  • Reports no leisure-time physical activity during the past month and engages in <400 MET-minutes/week of physical activity as assessed by the IPAQ-Short Form.
  • Has competing role demands, defined as ≥10 hours/week of paid work, caregiving, parenting, or volunteer activities.
  • Owns an iPhone (iOS smartphone) with reliable internet access and is willing to use study-related mobile applications and wearable devices.
  • Able to walk without assistance.
  • Uses, or is willing to use, a digital calendar application and share de-identified event timing data with the study team.
  • Able to understand study procedures and provide informed consent.

Exclusion Criteria:

  • Plans to relocate or engage in extended travel during the next 3 months.
  • Pregnant or planning to become pregnant during the study period.
  • Currently participating in another physical activity or behavioral intervention study.
  • Has a medical condition that may limit safe participation in walking, impair the ability to provide informed consent, or interfere with study adherence.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: ViaHabit Intervention

Participants complete a 2-week observation period during which individualized routine models are developed using wearable, smartphone, and calendar data, followed by a 4-week ViaHabit intervention consisting of routine-transition cue selection, if-then action planning, and automated smartwatch prompts to support initiation of 15-minute brisk walks.

ViaHabit is a personalized, cue-based walking intervention designed to promote physical activity habit formation in sedentary midlife adults. Following a 2-week observation period, individualized routine models are developed using data collected from wearable devices, smartphones, and digital calendars. Participants then complete a coaching session to identify up to two routine transitions that can serve as cues for physical activity and develop personalized if-then action plans linking each cue to a 15-minute brisk walk. During the 4-week intervention period, automated smartwatch notifications are delivered at the selected routine-transition cues to increase cue salience and support initiation of walking behavior. The intervention aims to strengthen cue-behavior associations through repeated pairing of routine completion cues with walking, thereby increasing behavioral automaticity and physical activity participation.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibliity of the ViaHabit Intervention - Recruitment
Periodo de tiempo: Week 8 (end of intervention)

Feasibility will be assessed by participant recruitment rates.

Week 8 (end of intervention)
Feasibliity of the ViaHabit Intervention - Retention
Periodo de tiempo: Week 8 (end of intervention)

Feasibility will be assessed by participant retention rates.

Week 8 (end of intervention)
Feasibliity of the ViaHabit Intervention - Data Collection
Periodo de tiempo: Week 8 (end of intervention)

Feasibility will be assessed by participant completion of Phase 1 data collection.

Week 8 (end of intervention)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Habit Strength for Walking
Periodo de tiempo: Baseline and weekly during the 4 week intervention period through Week 8

Habit strength will be assessed using the 4-item Self-Reported Behavioral Automaticity Index (SRBAI), adapted to each participant's selected routine-transition cue. Higher scores indicate greater automaticity of walking behavior in response to the cue.

Baseline and weekly during the 4 week intervention period through Week 8

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

30 de abril de 2027

Finalización del estudio (Estimado)

30 de junio de 2027

Fechas de registro del estudio

Enviado por primera vez

9 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

23 de septiembre de 2026

Publicado por primera vez (Actual)

29 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

23 de septiembre de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • AM260787
  • AM260787 (Otro número de subvención/financiamiento: University of Michigan Roybal Center)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .