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Personal Activity Intelligence and Body Weight

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Personal Activity Intelligence
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 Overweight focused on measuring Physical activity, Body weight, Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

The inclusion criteria for clinical study is healthy participants with a BMI > 25 and < 40.

Exclusion Criteria:

We will exclude people with severe illness or disabilities that preclude or hinder completion of the study or make exercise contradicted, uncontrolled hypertension, arrhythmias or angina, participation in conflicting interventions, primary pulmonary hypertension, diagnosed dementia or chronic communicable infectious diseases.

Sites / Locations

  • St. Olav´s University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Physical activity recommendations

PAI equal to or more than 100

PAI between 50 and 99

Arm Description

Participants in this group will be advised to engage in physical activity recommendations from health authorities, i.e., 150 minutes per week of moderate intensity activity or 75 minutes per week of vigourous intensity activity or combination of both that results in same caloric expenditure.

Participants in this group will be advised to obtain a PAI score of 100 or more over a week.

Participants in this group will be advised to obtain a PAI score between 50-99 over a week.

Outcomes

Primary Outcome Measures

changes in body weight - BMI
assessment of change in body weight/ BMI associated with PAI

Secondary Outcome Measures

Cardiovascular Risk Factors
change in CVD risk factors associated with PAI

Full Information

First Posted
August 23, 2017
Last Updated
April 18, 2018
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03260114
Brief Title
Personal Activity Intelligence and Body Weight
Official Title
Personal Activity Intelligence and Body Weight
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 24, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
March 30, 2018 (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
Yes

5. Study Description

Brief Summary
Physical activity is one of the key strategies used by public health agencies to combat the growing burden of obesity and non-communicable diseases. Adults around the world are recommended to engage in at least 150 minutes of moderate or 75 minutes of vigorous intensity activity per week, or a combination of moderate or vigorous activity that results in approximately the same total energy expenditure. However, majority of the population does not meet the physical activity recommendation. As barriers to physical activity, people mostly cite lack of time, self-motivation and confidence in the ability to be physically active. Cardiac Exercise Research Group (CERG) at Faculty of Medicine and Health Sciences at Norwegian University of Science and Technology recently developed Personal Activity Intelligence (PAI). PAI is a result of research based on the HUNT study where more than 60 000 individuals has been monitored over a period of more than 20 years. The goal is to make PAI the new world standard of activity tracking. PAI is an individual metric that makes sense of measured heart rate data, and significantly reduces the risk of lifestyle related diseases. The purpose of the study is to obtain new knowledge about how the use of PAI is related to body weight.
Detailed Description
The prevalence of obesity in the Western world is continuously increasing and the amount of obese persons among the adult population in the United States is now 35%. As a result of this growing problem, it is important and necessary to find an efficient way to prevent further weight gain in the population.Physical activity is one of the key strategies used by public health agencies to combat the growing burden of non-communicable diseases. As a result adults around the world are recommended to engage in at least 150 minutes of moderate or 75 minutes of vigorous intensity activity per week, or a combination of moderate or vigorous activity that results in approximately the same total energy expenditure. However, majority of the population does not meet the physical activity recommendation. As barriers to physical activity, people mostly cite lack of time, self-motivation and confidence in the ability to be physically active. Recently, using the HUNT study data, the Cardiac Exercise Research Group devised a simple metric termed Personal Activity Intelligence (PAI) which, using individual heart rate patterns of the body, estimates the optimal threshold of physical activity required for a specific objective: to decrease risk of premature death in an individual from the general population. The idea is to keep the weekly PAI score above 100. Since PAI is a personalized reflection of the body's response to physical activity based on heart rate, PAI score of 100 is specific to an individual. For example, a 100 PAI for a fit person is not the same as 100 PAI for an unfit person. PAI can be accumulated over a course of one week using physical activity of personal preference (i.e. walking, swimming, dancing, playing with grandchildren etc.) and allows for days with no activity as long as they are followed up by days of higher activity. However, the optimal amount and intensity (i.e. the number of PAI) of physical activity that would help for weight gain prevention still remains to be determined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Physical activity, Body weight, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
We aim to recruit 30 persons who meet the eligibility criteria. Eligible participants will be randomized 1:1:1 to usual care (control group), to two different PAI eHealth Programs (PAI ≥ 100 and PAI = 50 to <100) (N = 10). To provide balance across the trial arms for sex, and age groups (<40, 40-55, >55 years), participants will be allocated remotely by concealed minimisation.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical activity recommendations
Arm Type
No Intervention
Arm Description
Participants in this group will be advised to engage in physical activity recommendations from health authorities, i.e., 150 minutes per week of moderate intensity activity or 75 minutes per week of vigourous intensity activity or combination of both that results in same caloric expenditure.
Arm Title
PAI equal to or more than 100
Arm Type
Active Comparator
Arm Description
Participants in this group will be advised to obtain a PAI score of 100 or more over a week.
Arm Title
PAI between 50 and 99
Arm Type
Active Comparator
Arm Description
Participants in this group will be advised to obtain a PAI score between 50-99 over a week.
Intervention Type
Other
Intervention Name(s)
Personal Activity Intelligence
Intervention Description
Participants randomized to the PAI eHealth program will be given a Mio Slice wristband (http://www.mioglobal.com/pai/), to measure the heart rate for calculating PAI. A weekly PAI of 100 can be achieved by a combination of different exercise intensities and the participants will, at any time, get information from the device (Mio Slice) (and the PAI App if they chose to use that as well) regarding how many minutes at specified heart rates is needed to achieve the weekly goal of 100 PAI. Participants will receive automatic feedback on a daily basis, and data will be automatically recorded on a secured server.
Primary Outcome Measure Information:
Title
changes in body weight - BMI
Description
assessment of change in body weight/ BMI associated with PAI
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Cardiovascular Risk Factors
Description
change in CVD risk factors associated with PAI
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The inclusion criteria for clinical study is healthy participants with a BMI > 25 and < 40. Exclusion Criteria: We will exclude people with severe illness or disabilities that preclude or hinder completion of the study or make exercise contradicted, uncontrolled hypertension, arrhythmias or angina, participation in conflicting interventions, primary pulmonary hypertension, diagnosed dementia or chronic communicable infectious diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javaid Nauman, PhD
Organizational Affiliation
Norwegian University of Science and Technology, Trondheim, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Olav´s University Hospital
City
Trondheim
State/Province
Sor Trondelag
ZIP/Postal Code
7030
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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