<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03260114</url>
  </required_header>
  <id_info>
    <org_study_id>2017/319/REK midt</org_study_id>
    <nct_id>NCT03260114</nct_id>
  </id_info>
  <brief_title>Personal Activity Intelligence and Body Weight</brief_title>
  <official_title>Personal Activity Intelligence and Body Weight</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Physical activity is one of the key strategies used by public health agencies to combat the&#xD;
      growing burden of obesity and non-communicable diseases. Adults around the world are&#xD;
      recommended to engage in at least 150 minutes of moderate or 75 minutes of vigorous intensity&#xD;
      activity per week, or a combination of moderate or vigorous activity that results in&#xD;
      approximately the same total energy expenditure. However, majority of the population does not&#xD;
      meet the physical activity recommendation. As barriers to physical activity, people mostly&#xD;
      cite lack of time, self-motivation and confidence in the ability to be physically active.&#xD;
      Cardiac Exercise Research Group (CERG) at Faculty of Medicine and Health Sciences at&#xD;
      Norwegian University of Science and Technology recently developed Personal Activity&#xD;
      Intelligence (PAI). PAI is a result of research based on the HUNT study where more than 60&#xD;
      000 individuals has been monitored over a period of more than 20 years. The goal is to make&#xD;
      PAI the new world standard of activity tracking. PAI is an individual metric that makes sense&#xD;
      of measured heart rate data, and significantly reduces the risk of lifestyle related&#xD;
      diseases.&#xD;
&#xD;
      The purpose of the study is to obtain new knowledge about how the use of PAI is related to&#xD;
      body weight.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence of obesity in the Western world is continuously increasing and the amount of&#xD;
      obese persons among the adult population in the United States is now 35%. As a result of this&#xD;
      growing problem, it is important and necessary to find an efficient way to prevent further&#xD;
      weight gain in the population.Physical activity is one of the key strategies used by public&#xD;
      health agencies to combat the growing burden of non-communicable diseases. As a result adults&#xD;
      around the world are recommended to engage in at least 150 minutes of moderate or 75 minutes&#xD;
      of vigorous intensity activity per week, or a combination of moderate or vigorous activity&#xD;
      that results in approximately the same total energy expenditure. However, majority of the&#xD;
      population does not meet the physical activity recommendation. As barriers to physical&#xD;
      activity, people mostly cite lack of time, self-motivation and confidence in the ability to&#xD;
      be physically active.&#xD;
&#xD;
      Recently, using the HUNT study data, the Cardiac Exercise Research Group devised a simple&#xD;
      metric termed Personal Activity Intelligence (PAI) which, using individual heart rate&#xD;
      patterns of the body, estimates the optimal threshold of physical activity required for a&#xD;
      specific objective: to decrease risk of premature death in an individual from the general&#xD;
      population. The idea is to keep the weekly PAI score above 100. Since PAI is a personalized&#xD;
      reflection of the body's response to physical activity based on heart rate, PAI score of 100&#xD;
      is specific to an individual. For example, a 100 PAI for a fit person is not the same as 100&#xD;
      PAI for an unfit person. PAI can be accumulated over a course of one week using physical&#xD;
      activity of personal preference (i.e. walking, swimming, dancing, playing with grandchildren&#xD;
      etc.) and allows for days with no activity as long as they are followed up by days of higher&#xD;
      activity. However, the optimal amount and intensity (i.e. the number of PAI) of physical&#xD;
      activity that would help for weight gain prevention still remains to be determined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 24, 2017</start_date>
  <completion_date type="Actual">March 30, 2018</completion_date>
  <primary_completion_date type="Actual">March 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_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 &lt;100) (N = 10). To provide balance across the trial arms for sex, and age groups (&lt;40, 40-55, &gt;55 years), participants will be allocated remotely by concealed minimisation.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in body weight - BMI</measure>
    <time_frame>12 weeks</time_frame>
    <description>assessment of change in body weight/ BMI associated with PAI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular Risk Factors</measure>
    <time_frame>12 weeks</time_frame>
    <description>change in CVD risk factors associated with PAI</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Physical activity recommendations</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PAI equal to or more than 100</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this group will be advised to obtain a PAI score of 100 or more over a week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PAI between 50 and 99</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this group will be advised to obtain a PAI score between 50-99 over a week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Personal Activity Intelligence</intervention_name>
    <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.</description>
    <arm_group_label>PAI between 50 and 99</arm_group_label>
    <arm_group_label>PAI equal to or more than 100</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The inclusion criteria for clinical study is healthy participants with a BMI &gt; 25 and &lt; 40.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        We will exclude people with severe illness or disabilities that preclude or hinder&#xD;
        completion of the study or make exercise contradicted, uncontrolled hypertension,&#xD;
        arrhythmias or angina, participation in conflicting interventions, primary pulmonary&#xD;
        hypertension, diagnosed dementia or chronic communicable infectious diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Javaid Nauman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norwegian University of Science and Technology, Trondheim, Norway</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Olav´s University Hospital</name>
      <address>
        <city>Trondheim</city>
        <state>Sor Trondelag</state>
        <zip>7030</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>April 18, 2018</last_update_submitted>
  <last_update_submitted_qc>April 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physical activity</keyword>
  <keyword>Body weight</keyword>
  <keyword>Obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03260114
org study id: 2017/319/REK midt
nct id: NCT03260114
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Factorial Assignment
intervention 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.
primary purpose: Treatment
masking: None (Open Label)
measure: changes in body weight - BMI
time frame: 12 weeks
description: assessment of change in body weight/ BMI associated with PAI
measure: Cardiovascular Risk Factors
time frame: 12 weeks
description: change in CVD risk factors associated with PAI
arm group label: Physical activity recommendations
arm group type: No Intervention
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 group label: PAI equal to or more than 100
arm group type: Active Comparator
description: Participants in this group will be advised to obtain a PAI score of 100 or more over a week.
arm group label: PAI between 50 and 99
arm group type: Active Comparator
description: Participants in this group will be advised to obtain a PAI score between 50-99 over a week.
intervention type: Other
intervention name: Personal Activity Intelligence
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.
arm group label: PAI between 50 and 99
arm group label: PAI equal to or more than 100
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Javaid Nauman, PhD
role: Principal Investigator
affiliation: Norwegian University of Science and Technology, Trondheim, Norway
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Overweight
mesh term: Body Weight
sharing ipd: Undecided