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Clinical Trials/NCT03925363
NCT03925363UnknownNot Applicable

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

Region Västerbotten0 sites4,000 target enrollmentStarted: August 25, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
4,000
Primary Endpoint
Increased physical activity as measured by the mobile application in steps per day

Study Overview

Brief 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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
70 Years to 75 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Active

Active Comparator

Participants will be given a mobile-app where they will get feedback from the device based on their physical activity (feedback app)

Intervention: Physical activity mobile-application (Device)

Control

Sham Comparator

Participants will be given a mobile-app that does not give feedback back, but the app will register physical activity (blind app).

Intervention: Physical activity mobile-application (Device)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Number of participants with high blood glucose(1 year (anticipated))
  • Grade of obesity(1 year (anticipated))
  • Incidence of stroke(3 years)
  • Incidence of diagnosed dementia(3 years)
  • Incidence of diagnosed diabetes(3 years)
  • Number of participants with high blood lipids(1 year (anticipated))
  • Body weight(1 year (anticipated))
  • Number of participants with high glycated hemoglobin(1 year (anticipated))
  • Incidence of myocardial infarction(3 years)
  • Incidence of diagnosed fractures(3 years)
  • Number of participants with high blood pressure(1 year (anticipated))
  • Incidence of angina pectoris(3 years)
  • Incident mortality(3 years)

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Anna Nordström

Associate Professor

Region Västerbotten

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