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Use of Wearable Tech to Increase Physical Activity in Inpatient Rehabilitation for Overweight and Obese Patients

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Wearable tech with feedback
Wearable tech without feedback
Rehabilitation program
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Weight Loss, Rehabilitation, Exercise, Biomedical Technology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Unicare Helsefort

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Wearable tech with feedback

Wearable tech without feedback

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Activity level
Time spent in moderate to vigorous physical activity (minutes per day)
Number of PAIs
mean number of Personal Activity Intelligence (PAI) points achieved per week
Percentage achieving 100 Personal Activity Intelligence points (PAIs) per week

Secondary Outcome Measures

oxygen uptake
submaximal oxygen uptake measured by the Astrand bicycle test (described in Textbook of work physiology by Astrand from 1986)
Body weight
body weight in kilograms
Body Mass Index score
weight in kilograms divided by height in metres squared

Full Information

First Posted
July 22, 2019
Last Updated
January 24, 2020
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04031079
Brief Title
Use of Wearable Tech to Increase Physical Activity in Inpatient Rehabilitation for Overweight and Obese Patients
Official Title
Use of Wearable Tech to Increase Physical Activity in Inpatient Rehabilitation for Overweight and Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 12, 2019 (Actual)
Primary Completion Date
January 13, 2020 (Actual)
Study Completion Date
January 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Weight Loss, Rehabilitation, Exercise, Biomedical Technology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A parallel group design with two groups
Masking
Investigator
Masking Description
The researchers performing the analyses will be blinded
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wearable tech with feedback
Arm Type
Experimental
Arm Description
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).
Arm Title
Wearable tech without feedback
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Wearable tech with feedback
Intervention Description
an armwrist device measuring physical activity level. The user will receive information about their physical activity level through their smartphone
Intervention Type
Device
Intervention Name(s)
Wearable tech without feedback
Intervention Description
an armwrist device measuring physical activity level, no reporting back to the user
Intervention Type
Behavioral
Intervention Name(s)
Rehabilitation program
Intervention Description
traditional inpatient rehabilitation program for overweight and obesity (lifestyle change program)
Primary Outcome Measure Information:
Title
Activity level
Description
Time spent in moderate to vigorous physical activity (minutes per day)
Time Frame
4 weeks (time period at home between two stays at the rehabilitation center)
Title
Number of PAIs
Description
mean number of Personal Activity Intelligence (PAI) points achieved per week
Time Frame
4 weeks (time period at home between two stays at the rehabilitation center)
Title
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)
Secondary Outcome Measure Information:
Title
oxygen uptake
Description
submaximal oxygen uptake measured by the Astrand bicycle test (described in Textbook of work physiology by Astrand from 1986)
Time Frame
7 weeks (from inclusion to end of rehabilitation program)
Title
Body weight
Description
body weight in kilograms
Time Frame
7 weeks (from inclusion to end of rehabilitation program)
Title
Body Mass Index score
Description
weight in kilograms divided by height in metres squared
Time Frame
7 weeks (from inclusion to end of rehabilitation program)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lene Aasdahl, PhD MD
Organizational Affiliation
National Taiwan Normal University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jorunn Helbostad, Dr Philos
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Unicare Helsefort
City
Rissa
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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Use of Wearable Tech to Increase Physical Activity in Inpatient Rehabilitation for Overweight and Obese Patients

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