NCT03270202

Wearable Devices to Promote Physical Activity

The HUNT 4 PAI Study: A Randomized Controlled Intervention Study Using Wearable Devices to Promote Physical Activity

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 23 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the effect of a new wearable device, that measures physical activity level based on heart rates, on relevant health outcomes including cardiorespiratory fitness. Half of participants will be instructed in using the Mio Slice wristband, while the other half will be requested to follow today's recommendations for physical activity.

Detailed description

Two critical challenges precluding the full potential of physical activity in preventive healthcare are: 1) The majority of people are not sufficiently active, and 2) there is a lack of large, long-term intervention studies documenting the effect of personalized activity and improved health in the population. Using HUNT data an algorithm called Personal Activity Intelligence (PAI) has been developed. PAI was integrated in a smartphone application and user friendly wristband (Mio Slice), that measures heart rate continuously and estimates an individual threshold for total physical activity (defined as 100 weekly PAI) that is associated with reduced risk of cardiovascular disease and mortality. The primary aim of the study is to reveal whether using the wristband will increase cardiorespiratory fitness, determined by maximal oxygen uptake, after 4 months among low-fit participants. The secondary aims includes the effect on reversing cardiovascular risk factors, cardiac structure and function, adherence to physical activity and identification of barriers after 16 weeks and 1 year.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
BEHAVIORAL	PAI group	* physical activity defined as 100 weekly PAI during 1 year * smartphone application and a user-friendly activity wristband (Mio PAI Slice)
BEHAVIORAL	Usual care	Participants will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities.

Timeline

• Start date: 2017-10-01
• Primary completion: 2018-10-17
• Completion: 2018-10-17
• First posted: 2017-09-01
• Last updated: 2018-11-30

Locations

1 site across 1 country: Norway