- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07731659
Physical Activity Intervention for Individuals Newly Diagnosed With MS (ActivNMS)
Physical Activity Behavior Change Intervention in Persons Newly Diagnosed With Multiple Sclerosis - ActivNMS Trial - COM-B Construct Testing
The proposed study is a parallel-group randomized controlled trial (RCT) designed to establish the behavioral mechanism underlying a 16-week physical activity (PA) behavioral intervention through its effects on the Capability-Opportunity-Motivation-Behavior (COM-B) constructs. The success of this study will provide robust evidence for supporting its refinement via refined COM-B constructs and Behavior Change Techniques to facilitate or maximize the intervention effects on PA levels, which will be examined in the subsequent clinical trial. Such an approach will involve an RCT that examines the effects of a 16-week remotely delivered, Internet-based PA behavioral intervention via video behavioral coaching and newsletter compared with a waitlist control (WLC) condition for yielding improvements in the COM-B constructs among persons newly diagnosed with multiple sclerosis (PNDwMS, disease duration ≤ 2 years). The investigators hypothesize that participants in the PA behavioral intervention condition will demonstrate greater improvements in the COM-B constructs than those in the WLC condition. The investigators plan to recruit 50 PNDwMS, with a distribution of 25 participants in the PA behavioral intervention and 25 participants in the WLC condition. The primary outcomes are the self-report COM-B constructs (listed in the Outcomes section), which will be remotely assessed at baseline and post-intervention through an online battery of questionnaires via REDCap.
Specific Aim 1: to establish mechanisms for the behavior change intervention using a 2-arm pilot randomized controlled trial (RCT) of the intervention compared with the waitlist control (WLC) among PNDwMS. The investigators hypothesize that the 16-week COM-B-based behavioral intervention delivered by one-on-one behavior coaching and newsletters will result in larger changes in COM-B constructs (i.e., knowledge, outcome expectations, goal, intention, behavioral regulation, self-efficacy, fatigue, social support, and social and environmental barriers) than in the WLC group.
Specific Aim 2: to examine change in self-reported physical activity levels in PNDwMS who received the COM-B-based intervention compared with those who are in the waitlist control condition. The investigators hypothesize that the 16-week COM-B-based behavioral intervention will result in larger changes in self-reported physical activity outcomes than in the WLC group.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Lexi Huynh, PhD
- Número de teléfono: 312-996-6615
- Correo electrónico: activnms@uic.edu
Ubicaciones de estudio
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- University of Illinois Chicago
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Contacto:
- Lexi Huynh, PhD
- Número de teléfono: 312-996-6615
- Correo electrónico: activnms@uic.edu
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- aged 18 years or older
- self-reported diagnosis of MS by a neurologist within the past 2 years
- relapse-free for the past 30 days
- ability to speak and read English as the primary language
- internet and e-mail access
- willingness to complete study protocol
- ambulatory without an assistive device (PDDS < 3)
- insufficiently active (Godin Leisure-Time Exercise Questionnaire (GLTEQ) < 14)
- visual ability and literacy to read newsletter with font size 14 points
- on a stable disease-modifying therapy for 6 months
Exclusion Criteria:
- pregnant
- have an elevated risk for undertaking strenuous or maximal exercise based on two or more affirmatives on the Physical Activity Readiness Questionnaire (PAR-Q)
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 |
|---|---|
|
Sin intervención: Control de lista de espera
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Experimental: Treatment
COM-B-based Physical Activity Behavior Intervention
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Participants will receive a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular chats over Zoom with a behavioral coach: The newsletters provide behavioral strategies such as information on the benefits of physical activity, goal setting and monitoring, for increasing and maintaining physical activity levels. Throughout the 16-week period, the investigators will ask participants to wear a Fitbit and record step count into a logbook daily for tracking physical activity. The newsletter will be emailed to participants weekly throughout the program. The newsletters include knowledge, skills, and resources related to physical activity in the early stages of MS. The program also involves 7 1-on-1 coaching chats with a coach to guide participants through the program and navigate challenges. These chats are conducted over Zoom and generally last about 15 - 30 minutes each. These sessions will not be recorded. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Knowledge and Information Provision Questionnaire (NIP)
Periodo de tiempo: Baseline and week 16
|
The Knowledge and Information Provision questionnaire will be administered remotely for self-report assessment of knowledge about physical activity. 3 items; Likert scale 1 - 4 (No - Yes, comprehensively) |
Baseline and week 16
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|
Multidimensional Outcome Expectations for Exercise Scale (MOEES)
Periodo de tiempo: Baseline and week 16
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The MOEES will be administered remotely for self-report assessment of outcome expectations for physical activity/exercise. 15 items; Likert scale 1 - 5 (Strongly disagree - Strongly agree) |
Baseline and week 16
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|
Behavioral Intention
Periodo de tiempo: Baseline and week 16
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The behavioral intention will be administered remotely for physical activity behavioral intentions. 5 items; Likert scale 1- 4 (Not true - Completely true) |
Baseline and week 16
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Exercise Goal Setting Scale (EGS)
Periodo de tiempo: Baseline and week 16
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The EGS will be administered remotely to capture goal-setting skills.
It includes 10 items rates on a Likert scale with anchors of 1 (Does not describe) and 5 (Describes completely)
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Baseline and week 16
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Behavioral Regulation Action Planning (BRAP) Subscale
Periodo de tiempo: Baseline and week 16
|
The BRAP will be administered remotely for capturing the action planning construct.
5 items; Likert scale 1 - 4 (Not true - Completely true)
|
Baseline and week 16
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Behavioral Regulation Action Control (BRAC) Subscale
Periodo de tiempo: Baseline and week 16
|
The BRAC will be administered remotely for capturing the action control construct.
6 items; Likert scale 1 - 4 (Not true - Completely true)
|
Baseline and week 16
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HAPA Self-efficacy Subscales (Action, Recovery, Maintenance Subscale)
Periodo de tiempo: Baseline and week 16
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The Self-efficacy subscales will be administered remotely for capturing the self-efficacy levels in physical activity action, recovery, and maintenance.
9 items; Likert scale 1 - 4 (Not true - Exactly true)
|
Baseline and week 16
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|
Hamburg Quality of Life Questionnaire Multiple Sclerosis - Fatigue Subscale (HAQUAMSF)
Periodo de tiempo: Baseline and week 16
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The HAQUAMSF will be administered remotely for measuring fatigue 4 items; Likert scale 1 - 5 (Not at all - Very much)
|
Baseline and week 16
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|
The PA-Related Social Support Scale (PASS)
Periodo de tiempo: Baseline and week 16
|
The PA-Related Social Support Scale will be administered remotely for capturing physical activity social support 7 items; Likert scale 1 - 4 (Almost never - Almost always)
|
Baseline and week 16
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The Physical and Social Environment Barriers - Self-developed questionnaire
Periodo de tiempo: Baseline and week 16
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The Physical and Social Environment Barriers will be administered remotely for capturing barriers in physical and social environment. 9 items; Likert scale 1 - 4 (Is not applicable - Applicable) |
Baseline and week 16
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Physical Activity Behavior
Periodo de tiempo: Baseline and week 16
|
Godin Leisure-Time Exercise Questionnaire (GLTEQ); scores range between 0 (min) and 119 (max), higher scores indicate greater engagement in physical activity behavior.
|
Baseline and week 16
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Physical Activity Behavior
Periodo de tiempo: Baseline and week 16
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International Physical Activity Questionnaire (IPAQ); scores range between 0 (min) and 107 (max), higher scores indicate greater engagement in physical activity behavior.
|
Baseline and week 16
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Formative Evaluation
Periodo de tiempo: Week 16
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Self-report survey to assess participant satisfaction and collect feedback from participant.
|
Week 16
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Demographic information
Periodo de tiempo: Baseline
|
Self-report questionnaire will be administered remotely to capture age, sex, race, ethnicity, education, marital status, income
|
Baseline
|
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Clinical characteristics
Periodo de tiempo: Baseline and week 16
|
Self-report questionnaire will be administered remotely to capture MS type, disease duration, Patient Determined Disease Steps (PDDS)
|
Baseline and week 16
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Robert Motl, PhD, University of Illinois at Chicago
Publicaciones y enlaces útiles
Enlaces Útiles
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
Otros números de identificación del estudio
- STUDY2026-0787
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
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