- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03925363
A Mobile Application to Increase Physical Activity
A Mobile Application to Increase Physical Activity, a Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
Sham Comparator: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increased physical activity as measured by the mobile application in steps per day
Time Frame: 3 years (anticipated)
|
Increased physical activity in steps per day during the intervention period.
|
3 years (anticipated)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of myocardial infarction
Time Frame: 3 years
|
Diagnoses of myocardial infarction will be tracked using national registers.
|
3 years
|
Incidence of diagnosed diabetes
Time Frame: 3 years
|
Diabetes diagnoses or start of treatment for diabetes will be tracked using national registers.
|
3 years
|
Incidence of diagnosed fractures
Time Frame: 3 years
|
Diagnosed fractures will be tracked using national registers.
|
3 years
|
Incidence of diagnosed dementia
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 1 year (anticipated)
|
Obesity will be assessed using a non-elastic measurement tape at the waist
|
1 year (anticipated)
|
Body weight
Time Frame: 1 year (anticipated)
|
Body weight in kilogram measured by a digital scale.
|
1 year (anticipated)
|
Incidence of stroke
Time Frame: 3 years
|
Diagnoses of stroke will be tracked using national registers.
|
3 years
|
Incidence of angina pectoris
Time Frame: 3 years
|
Diagnoses of angina pectoris will be tracked using national registers.
|
3 years
|
Incident mortality
Time Frame: 3 years
|
Death during follow up will be tracked using national registers.
|
3 years
|
Number of participants with high glycated hemoglobin
Time Frame: 1 year (anticipated)
|
Glycated hemoglobin will be measured at baseline and follow up at the Department of clinical chemistry
|
1 year (anticipated)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- VCC_LIFE-5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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