- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03925363
A Mobile Application to Increase Physical Activity
A Mobile Application to Increase Physical Activity, a Randomized Controlled Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
In this randomized controlled study, it will be tested if a mobile application can increase physical activity and reduce the risk of later non-communicable disease.
Participants include individuals that previously have been included in a health survey (Healthy aging initiative, NCT03312439), with a low registered physical activity. Low physical is defined according to WHOs definition, i.e. at least 150 minutes of physical activity per week. Individuals will diabetes will be investigated separately.
Individuals will be excluded that cannot walk for exercise, or if they have diseases that severely affects the ability to exercise. We will also seek participants from the general population to be included with only two inclusion criteria; having a smart phone and at least 18 years of age.
Participants the meet the inclusion criteria will be randomized to an application that only registers physical activity (blind-app) or an application where the participants will set appropriate goals for physical activity and get proper feedback from the app when these goals are reached (feedback-app). Both groups will have individualized information about proper physical activity. Randomization will be made using sealed envelopes in permuted blocks of 10. Randomization will be stratified on year of birth and sex.
The primary outcome will be increased physical activity after 6 months. Secondary outcomes include cardiovascular disease, death, dementia, falls and fractures, diabetes, and improved glucose control in those that already have diabetes. Secondary outcomes also include changes in cardiovascular risk factors, such as blood pressure, blood lipids and obesity. Interaction analysis will be performed to investigate if the effects are different in men and women, based on baseline physical activity and based on age.
Based on the results from the previous health survey the individuals have participated in, a power analyses has been conducted. The participants physical activity were registered using accelerometers. The mean steps taken per week was 48000 with a standard deviation of 22000 steps. With assumption that the feedback-app will increase physical activity by at least 15%, 164 individuals would be needed in each group with an alpha level of 0.05 and a power of 80%. For secondary outcome of cardiovascular disease or death, estimates were based on incidence of these outcomes in 3617 individuals that participated in the health survey. During a mean follow up time of 928 days, 221 participants was diagnosed with cardiovascular disease or died during follow up, and 128 were diagnosed with cardiovascular disease. If assuming that the mobil-application will result in 15% lower risk of these two outcomes in those randomized to the feedback-app, 597 and 1371 individuals would be needed in each group, respectively, with the same follow up time. The effects during follow up will be monitored each year of follow up through patient registers. Follow up time is scheduled to a maximum of 2 years. We estimate that we then would need 895 and 2156 individuals in each group due to the shorter follow up time compared to in the example above.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Previous participants in healthy aging initiative.
Exclusion Criteria:
- Not able to walk or previous medical diagnoses that severely limits the possibility to exercise.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Active
Participants will be given a mobile-app where they will get feedback from the device based on their physical activity (feedback app)
|
The active group will be given the feedback app and the control group the blind app
|
Comparador falso: Control
Participants will be given a mobile-app that does not give feedback back, but the app will register physical activity (blind app).
|
The active group will be given the feedback app and the control group the blind app
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Increased physical activity as measured by the mobile application in steps per day
Periodo de tiempo: 3 years (anticipated)
|
Increased physical activity in steps per day during the intervention period.
|
3 years (anticipated)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Incidence of myocardial infarction
Periodo de tiempo: 3 years
|
Diagnoses of myocardial infarction will be tracked using national registers.
|
3 years
|
Incidence of diagnosed diabetes
Periodo de tiempo: 3 years
|
Diabetes diagnoses or start of treatment for diabetes will be tracked using national registers.
|
3 years
|
Incidence of diagnosed fractures
Periodo de tiempo: 3 years
|
Diagnosed fractures will be tracked using national registers.
|
3 years
|
Incidence of diagnosed dementia
Periodo de tiempo: 3 years
|
Diagnosed dementia or start of treatment using dementia drugs will be tracked using national registers.
|
3 years
|
Number of participants with high blood pressure
Periodo de tiempo: 1 year (anticipated)
|
Systolic and diastolic blood pressure will be assessed at baseline and later using a sphygmomanometer.
|
1 year (anticipated)
|
Number of participants with high blood lipids
Periodo de tiempo: 1 year (anticipated)
|
Blood lipids (cholesterol, LDL-cholesterol, and triglycerides) will be analyzed at baseline and after 6 and 12 months at the department of chemistry.
|
1 year (anticipated)
|
Number of participants with high blood glucose
Periodo de tiempo: 1 year (anticipated)
|
Blood glucose will be analysed at the departement of clinical chemistry at baseline and follow up.
|
1 year (anticipated)
|
Grade of obesity
Periodo de tiempo: 1 year (anticipated)
|
Obesity will be assessed using a non-elastic measurement tape at the waist
|
1 year (anticipated)
|
Body weight
Periodo de tiempo: 1 year (anticipated)
|
Body weight in kilogram measured by a digital scale.
|
1 year (anticipated)
|
Incidence of stroke
Periodo de tiempo: 3 years
|
Diagnoses of stroke will be tracked using national registers.
|
3 years
|
Incidence of angina pectoris
Periodo de tiempo: 3 years
|
Diagnoses of angina pectoris will be tracked using national registers.
|
3 years
|
Incident mortality
Periodo de tiempo: 3 years
|
Death during follow up will be tracked using national registers.
|
3 years
|
Number of participants with high glycated hemoglobin
Periodo de tiempo: 1 year (anticipated)
|
Glycated hemoglobin will be measured at baseline and follow up at the Department of clinical chemistry
|
1 year (anticipated)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Otros números de identificación del estudio
- VCC_LIFE-5
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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