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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04031079
Other study ID # 2019/799
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 12, 2019
Est. completion date January 13, 2020

Study information

Verified date January 2020
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this project is to evaluate whether use of wearable tech increases physical activity in patients participating in inpatient rehabilitation for overweight and obesity.


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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date January 13, 2020
Est. primary completion date January 13, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Wearable tech with feedback
an armwrist device measuring physical activity level. The user will receive information about their physical activity level through their smartphone
Wearable tech without feedback
an armwrist device measuring physical activity level, no reporting back to the user
Behavioral:
Rehabilitation program
traditional inpatient rehabilitation program for overweight and obesity (lifestyle change program)

Locations

Country Name City State
Norway Unicare Helsefort Rissa

Sponsors (1)

Lead Sponsor Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Activity level Time spent in moderate to vigorous physical activity (minutes per day) 4 weeks (time period at home between two stays at the rehabilitation center)
Primary Number of PAIs mean number of Personal Activity Intelligence (PAI) points achieved per week 4 weeks (time period at home between two stays at the rehabilitation center)
Primary Percentage achieving 100 Personal Activity Intelligence points (PAIs) per week 4 weeks (time period at home between two stays at the rehabilitation center)
Secondary oxygen uptake 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)
Secondary Body weight body weight in kilograms 7 weeks (from inclusion to end of rehabilitation program)
Secondary Body Mass Index score weight in kilograms divided by height in metres squared 7 weeks (from inclusion to end of rehabilitation program)
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