- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04031079
Use of Wearable Tech to Increase Physical Activity in Inpatient Rehabilitation for Overweight and Obese Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Obesity is a global epidemic with profound consequences for individuals and societies. Physical exercise is important for weight reduction and weight loss maintenance. Use of wearable tech might facilitate physical activity. Here it will be evaluated whether use of wearable tech that gives feedback about the user's activity level, increases physical activity in people participating in inpatient rehabilitation for overweight and obesity. The control group will be wearing the same wearable tech as the intervention group, but they will not receive any feedback about their activity level.
The feedback application will give participants in the intervention group information about the number of PAI they earn each week. PAI is short for Personal Activity Intelligence. One earns PAI points every time heart rate increases: The higher heart rate, the faster one earns PAI. Previous research have shown that those who achieve 100 PAI or more every week over time, live for an average of more than eight years longer than others.
During the study all participants will take part in a traditional inpatient rehabilitation program (lifestyle modification program). The program consist of three periods at the rehabilitation center with time at home in-between. The study will take place during two periods at the center and one period at home. Time spent on physical activity and number of earned PAI's will be counted during the period at home.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Rissa, Norway
- Unicare Helsefort
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- taking part in inpatient rehabilitation at Unicare Helefort Rehabilitation center for overweight or obesity.
- having been referred from a hospital outpatient obesity clinic.
Exclusion Criteria:
- not having a smartphone (will not be able to access the mobile application).
- using a wheelchair (the technology will be not able to measure activity correctly)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Wearable tech with feedback
This group will be wearing an activity measurement device (wristband) and receive feedback about their activity level through a mobile application while taking part in a traditional inpatient rehabilitation program for overweight and obesity (lifestyle change program).
|
an armwrist device measuring physical activity level.
The user will receive information about their physical activity level through their smartphone
traditional inpatient rehabilitation program for overweight and obesity (lifestyle change program)
|
Active Comparator: Wearable tech without feedback
This group will be wearing the same the activity measurement device as the intervention group, but they will not receive any feedback about their activity level.
They will not have access to the mobile application.
They will take part in the same rehabilitation program as the intervention group.
|
traditional inpatient rehabilitation program for overweight and obesity (lifestyle change program)
an armwrist device measuring physical activity level, no reporting back to the user
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activity level
Time Frame: 4 weeks (time period at home between two stays at the rehabilitation center)
|
Time spent in moderate to vigorous physical activity (minutes per day)
|
4 weeks (time period at home between two stays at the rehabilitation center)
|
Number of PAIs
Time Frame: 4 weeks (time period at home between two stays at the rehabilitation center)
|
mean number of Personal Activity Intelligence (PAI) points achieved per week
|
4 weeks (time period at home between two stays at the rehabilitation center)
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Percentage achieving 100 Personal Activity Intelligence points (PAIs) per week
Time Frame: 4 weeks (time period at home between two stays at the rehabilitation center)
|
4 weeks (time period at home between two stays at the rehabilitation center)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
oxygen uptake
Time Frame: 7 weeks (from inclusion to end of rehabilitation program)
|
submaximal oxygen uptake measured by the Astrand bicycle test (described in Textbook of work physiology by Astrand from 1986)
|
7 weeks (from inclusion to end of rehabilitation program)
|
Body weight
Time Frame: 7 weeks (from inclusion to end of rehabilitation program)
|
body weight in kilograms
|
7 weeks (from inclusion to end of rehabilitation program)
|
Body Mass Index score
Time Frame: 7 weeks (from inclusion to end of rehabilitation program)
|
weight in kilograms divided by height in metres squared
|
7 weeks (from inclusion to end of rehabilitation program)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lene Aasdahl, PhD MD, National Taiwan Normal University
- Study Director: Jorunn Helbostad, Dr Philos, Norwegian University of Science and Technology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/799
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
product manufactured in and exported from the U.S.
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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