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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04031079
Recruitment Status : Completed
First Posted : July 24, 2019
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Device: Wearable tech with feedback Device: Wearable tech without feedback Behavioral: Rehabilitation program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A parallel group design with two groups
Masking: Single (Investigator)
Masking Description: The researchers performing the analyses will be blinded
Primary Purpose: Treatment
Official Title: Use of Wearable Tech to Increase Physical Activity in Inpatient Rehabilitation for Overweight and Obese Patients
Actual Study Start Date : August 12, 2019
Actual Primary Completion Date : January 13, 2020
Actual Study Completion Date : January 13, 2020

Resource links provided by the National Library of Medicine


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).
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

Behavioral: Rehabilitation program
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.
Device: 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)




Primary Outcome Measures :
  1. 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)

  2. 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

  3. 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 Measures :
  1. 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)

  2. Body weight [ Time Frame: 7 weeks (from inclusion to end of rehabilitation program) ]
    body weight in kilograms

  3. Body Mass Index score [ Time Frame: 7 weeks (from inclusion to end of rehabilitation program) ]
    weight in kilograms divided by height in metres squared



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04031079


Locations
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Norway
Unicare Helsefort
Rissa, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
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Principal Investigator: Lene Aasdahl, PhD MD National Taiwan Normal University
Study Director: Jorunn Helbostad, Dr Philos Norwegian University of Science and Technology

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT04031079    
Other Study ID Numbers: 2019/799
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Weight Loss
Rehabilitation
Exercise
Biomedical Technology
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms