A Mobile Application to Increase Physical Activity

NCT03925363 | Unknown DMC

• 1 other identifier: VCC_LIFE-5
• Study Type: interventional
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Incidence of myocardial infarction

  3 years

• Incidence of diagnosed diabetes

  3 years

• Incidence of diagnosed fractures

  3 years

• Incidence of diagnosed dementia

  3 years

• Number of participants with high blood pressure

  1 year (anticipated)

Study Arms (2)

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)

Device: Physical activity mobile-application

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).

Device: Physical activity mobile-application

Interventions

Physical activity mobile-application DEVICE

The active group will be given the feedback app and the control group the blind app

Active; Control

Eligibility Criteria

• Age: 70 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Previous participants in healthy aging initiative.

You may not qualify if:

• Not able to walk or previous medical diagnoses that severely limits the possibility to exercise.

Sponsors & Collaborators

• Region Västerbotten: lead
• Umeå University: collaborator

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized 1:1 to the feedback-app or the blind-app

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: April 24, 2019
• Study Start: August 25, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2023
• Last Updated: July 2, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share