A Mobile Application to Increase Physical Activity

Physical Activity Clinical Trial

Official title:

A Mobile Application to Increase Physical Activity, a Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03925363
• Other study ID #: VCC_LIFE-5
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 25, 2019
• Est. completion date: January 1, 2023

Study information

• Verified date: June 2019
• Source: Västerbotten County Council
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A mobile application will be tested in elderly men and women that is randomized to an application (blind-app) that registers physical activity or an application (feedback-app) where participants in addition set goals for physical activity and gets feedback from the application when these goals are achieved. Participants are randomized in permuted blocks of 10 to the blind-app or feedback-app. The primary outcome is increased physical activity. Secondary outcomes include, cardiovascular disease, diabetes, death, dementia, cancer, falls and fractures.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Physical Activity

Intervention

Device:
• Physical activity mobile-application
The active group will be given the feedback app and the control group the blind app

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Västerbotten County Council	Umeå University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increased physical activity as measured by the mobile application in steps per day	Increased physical activity in steps per day during the intervention period.	3 years (anticipated)
Secondary	Incidence of myocardial infarction	Diagnoses of myocardial infarction will be tracked using national registers.	3 years
Secondary	Incidence of diagnosed diabetes	Diabetes diagnoses or start of treatment for diabetes will be tracked using national registers.	3 years
Secondary	Incidence of diagnosed fractures	Diagnosed fractures will be tracked using national registers.	3 years
Secondary	Incidence of diagnosed dementia	Diagnosed dementia or start of treatment using dementia drugs will be tracked using national registers.	3 years
Secondary	Number of participants with high blood pressure	Systolic and diastolic blood pressure will be assessed at baseline and later using a sphygmomanometer.	1 year (anticipated)
Secondary	Number of participants with high blood lipids	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)
Secondary	Number of participants with high blood glucose	Blood glucose will be analysed at the departement of clinical chemistry at baseline and follow up.	1 year (anticipated)
Secondary	Grade of obesity	Obesity will be assessed using a non-elastic measurement tape at the waist	1 year (anticipated)
Secondary	Body weight	Body weight in kilogram measured by a digital scale.	1 year (anticipated)
Secondary	Incidence of stroke	Diagnoses of stroke will be tracked using national registers.	3 years
Secondary	Incidence of angina pectoris	Diagnoses of angina pectoris will be tracked using national registers.	3 years
Secondary	Incident mortality	Death during follow up will be tracked using national registers.	3 years
Secondary	Number of participants with high glycated hemoglobin	Glycated hemoglobin will be measured at baseline and follow up at the Department of clinical chemistry	1 year (anticipated)