- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03260114
Personal Activity Intelligence and Body Weight
Physical activity is one of the key strategies used by public health agencies to combat the growing burden of obesity and non-communicable diseases. Adults around the world are recommended to engage in at least 150 minutes of moderate or 75 minutes of vigorous intensity activity per week, or a combination of moderate or vigorous activity that results in approximately the same total energy expenditure. However, majority of the population does not meet the physical activity recommendation. As barriers to physical activity, people mostly cite lack of time, self-motivation and confidence in the ability to be physically active. Cardiac Exercise Research Group (CERG) at Faculty of Medicine and Health Sciences at Norwegian University of Science and Technology recently developed Personal Activity Intelligence (PAI). PAI is a result of research based on the HUNT study where more than 60 000 individuals has been monitored over a period of more than 20 years. The goal is to make PAI the new world standard of activity tracking. PAI is an individual metric that makes sense of measured heart rate data, and significantly reduces the risk of lifestyle related diseases.
The purpose of the study is to obtain new knowledge about how the use of PAI is related to body weight.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The prevalence of obesity in the Western world is continuously increasing and the amount of obese persons among the adult population in the United States is now 35%. As a result of this growing problem, it is important and necessary to find an efficient way to prevent further weight gain in the population.Physical activity is one of the key strategies used by public health agencies to combat the growing burden of non-communicable diseases. As a result adults around the world are recommended to engage in at least 150 minutes of moderate or 75 minutes of vigorous intensity activity per week, or a combination of moderate or vigorous activity that results in approximately the same total energy expenditure. However, majority of the population does not meet the physical activity recommendation. As barriers to physical activity, people mostly cite lack of time, self-motivation and confidence in the ability to be physically active.
Recently, using the HUNT study data, the Cardiac Exercise Research Group devised a simple metric termed Personal Activity Intelligence (PAI) which, using individual heart rate patterns of the body, estimates the optimal threshold of physical activity required for a specific objective: to decrease risk of premature death in an individual from the general population. The idea is to keep the weekly PAI score above 100. Since PAI is a personalized reflection of the body's response to physical activity based on heart rate, PAI score of 100 is specific to an individual. For example, a 100 PAI for a fit person is not the same as 100 PAI for an unfit person. PAI can be accumulated over a course of one week using physical activity of personal preference (i.e. walking, swimming, dancing, playing with grandchildren etc.) and allows for days with no activity as long as they are followed up by days of higher activity. However, the optimal amount and intensity (i.e. the number of PAI) of physical activity that would help for weight gain prevention still remains to be determined.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Sor Trondelag
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Trondheim, Sor Trondelag, Noruega, 7030
- St. Olav´s University Hospital
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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:
The inclusion criteria for clinical study is healthy participants with a BMI > 25 and < 40.
Exclusion Criteria:
We will exclude people with severe illness or disabilities that preclude or hinder completion of the study or make exercise contradicted, uncontrolled hypertension, arrhythmias or angina, participation in conflicting interventions, primary pulmonary hypertension, diagnosed dementia or chronic communicable infectious diseases.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Physical activity recommendations
Participants in this group will be advised to engage in physical activity recommendations from health authorities, i.e., 150 minutes per week of moderate intensity activity or 75 minutes per week of vigourous intensity activity or combination of both that results in same caloric expenditure.
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Comparador activo: PAI equal to or more than 100
Participants in this group will be advised to obtain a PAI score of 100 or more over a week.
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Participants randomized to the PAI eHealth program will be given a Mio Slice wristband (http://www.mioglobal.com/pai/), to measure the heart rate for calculating PAI.
A weekly PAI of 100 can be achieved by a combination of different exercise intensities and the participants will, at any time, get information from the device (Mio Slice) (and the PAI App if they chose to use that as well) regarding how many minutes at specified heart rates is needed to achieve the weekly goal of 100 PAI.
Participants will receive automatic feedback on a daily basis, and data will be automatically recorded on a secured server.
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Comparador activo: PAI between 50 and 99
Participants in this group will be advised to obtain a PAI score between 50-99 over a week.
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Participants randomized to the PAI eHealth program will be given a Mio Slice wristband (http://www.mioglobal.com/pai/), to measure the heart rate for calculating PAI.
A weekly PAI of 100 can be achieved by a combination of different exercise intensities and the participants will, at any time, get information from the device (Mio Slice) (and the PAI App if they chose to use that as well) regarding how many minutes at specified heart rates is needed to achieve the weekly goal of 100 PAI.
Participants will receive automatic feedback on a daily basis, and data will be automatically recorded on a secured server.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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changes in body weight - BMI
Periodo de tiempo: 12 weeks
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assessment of change in body weight/ BMI associated with PAI
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12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cardiovascular Risk Factors
Periodo de tiempo: 12 weeks
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change in CVD risk factors associated with PAI
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12 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Javaid Nauman, PhD, Norwegian University of Science and Technology, Trondheim, Norway
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- 2017/319/REK midt
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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Ensayos clínicos sobre Personal Activity Intelligence
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University of Illinois at ChicagoNational Institute of Mental Health (NIMH); Emory University; University of Mississippi... y otros colaboradoresTerminadoAdherencia a la medicación | Retención en CuidadoEstados Unidos
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Institute of Mountain Emergency MedicineTerminadoReanimación cardiopulmonar | Equipo de protección personalItalia
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KarmelSonix Ltd.Terminado
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Global Kinetics CorporationRetirado
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University of Kansas Medical CenterTerminado
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Manchester Metropolitan UniversityThe Stroke Association, United KingdomTerminadoNeumonía | Disfagia | Accidente cerebrovascular agudoReino Unido