search
Back to results

New Health Devices to Improve Adherence to Physical Activity in Overweight Inactive Adults

Primary Purpose

Cardiovascular Diseases, Obesity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Pai APP
FitBit APP
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cardiovascular Diseases focused on measuring healthy volunteers, patient compliance, exercise, motivation

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Body mass index > 25
  • self reported exercise one time or less per week

Exclusion Criteria:

  • inability to use a SmartPhone
  • illness or disabilities that preclude or hinder completion of the study
  • cancer that makes participation impossible or exercise contraindicated (considered individually, in consultation with physician)
  • test results indicating that study participation is unsafe
  • participation in other studies conflicting with participation in this study
  • symptomatic valvular, hypertrophic cardiomyopathy, unstable angina, primary pulmonary hypertension, uncontrolled hypertension, heart failure or sever arrhythmia
  • diagnosed dementia
  • chronic communicable infectious diseases
  • Bariatric surgery
  • Medication for thyroid disease, diabetes, blood pressure or lipid lowering medication

Sites / Locations

  • Institutt for sirkulasjon og bildediagnostikk

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PAI APP

FitBit APP

Arm Description

personal activity index application

Outcomes

Primary Outcome Measures

The proportion of the participants obtaining 80 % or more of the prescribed physical activity for one year
Prescribed 100 PAI weekly (PAI app group), or 10 000 steps daily (step counter app)

Secondary Outcome Measures

Cardiorespiratory fitness
Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany
Cardiorespiratory fitness
Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany
Resting blood pressure
Left upper arm, right upper arm, orthostatic hypotension
Resting blood pressure
Left upper arm, right upper arm, orthostatic hypotension
Resting heart rate
Resting heart rate
Body mass index
Height, weight
Body mass index
Height, weight
Waist line
in centimeters
Waist line
in centimeters
Body composition
body composition measured by bioelectrical impedance (InBody 720, BIOSPACE, Seoul, Korea)
Body composition
body composition measured by bioelectrical impedance (InBody 720, BIOSPACE, Seoul, Korea)
Activity questionnaire
HUNT-1 questionnaire 2 "exercise"
Activity questionnaire
HUNT-1 questionnaire 2 "exercise"
glucose concentration in blood
glucose concentration in blood
glycosylated haemoglobin (HbA1c) concentration in blood
glycosylated haemoglobin (HbA1c) concentration in blood
c-peptide concentration in blood
c-peptide concentration in blood
concentration of triglycerides in blood serum
concentration of triglycerides in blood serum
concentration of total cholesterol in blood
concentration of total cholesterol in blood
concentration of low density lipid (LDL) cholesterol in blood
concentration of low density lipid (LDL) cholesterol in blood
concentration of high density lipid (HDL) cholesterol in blood
concentration of high density lipid (HDL) cholesterol in blood

Full Information

First Posted
May 13, 2016
Last Updated
September 21, 2017
Sponsor
Norwegian University of Science and Technology
search

1. Study Identification

Unique Protocol Identification Number
NCT02774655
Brief Title
New Health Devices to Improve Adherence to Physical Activity in Overweight Inactive Adults
Official Title
New Health Devices to Improve Adherence to Physical Activity in Overweight Inactive Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
September 2017 (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 purpose of this study is to test in overweight and inactive adults whether the new PAI eHealh APP leads to better adherence to a physical activity regimen than the wearable step counter App from the market leader FitBit, and to evaluate if improved adherence will be reflected in a better cardiovascular profile in this group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Obesity
Keywords
healthy volunteers, patient compliance, exercise, motivation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PAI APP
Arm Type
Experimental
Arm Description
personal activity index application
Arm Title
FitBit APP
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Pai APP
Other Intervention Name(s)
personal activity Intelligence (PAI) application, Mio Fuse wristband
Intervention Description
prescribed 100 PAI weekly
Intervention Type
Device
Intervention Name(s)
FitBit APP
Other Intervention Name(s)
FitBit zip step counter
Intervention Description
prescribed 10000 steps daily
Primary Outcome Measure Information:
Title
The proportion of the participants obtaining 80 % or more of the prescribed physical activity for one year
Description
Prescribed 100 PAI weekly (PAI app group), or 10 000 steps daily (step counter app)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Cardiorespiratory fitness
Description
Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany
Time Frame
1 year
Title
Cardiorespiratory fitness
Description
Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany
Time Frame
16 weeks
Title
Resting blood pressure
Description
Left upper arm, right upper arm, orthostatic hypotension
Time Frame
16 weeks
Title
Resting blood pressure
Description
Left upper arm, right upper arm, orthostatic hypotension
Time Frame
1 year
Title
Resting heart rate
Time Frame
16 weeks
Title
Resting heart rate
Time Frame
1 year
Title
Body mass index
Description
Height, weight
Time Frame
16 weeks
Title
Body mass index
Description
Height, weight
Time Frame
1 year
Title
Waist line
Description
in centimeters
Time Frame
16 weeks
Title
Waist line
Description
in centimeters
Time Frame
1 year
Title
Body composition
Description
body composition measured by bioelectrical impedance (InBody 720, BIOSPACE, Seoul, Korea)
Time Frame
16 weeks
Title
Body composition
Description
body composition measured by bioelectrical impedance (InBody 720, BIOSPACE, Seoul, Korea)
Time Frame
1 year
Title
Activity questionnaire
Description
HUNT-1 questionnaire 2 "exercise"
Time Frame
16 weeks
Title
Activity questionnaire
Description
HUNT-1 questionnaire 2 "exercise"
Time Frame
1 year
Title
glucose concentration in blood
Time Frame
16 weeks
Title
glucose concentration in blood
Time Frame
1 year
Title
glycosylated haemoglobin (HbA1c) concentration in blood
Time Frame
16 weeks
Title
glycosylated haemoglobin (HbA1c) concentration in blood
Time Frame
1 year
Title
c-peptide concentration in blood
Time Frame
16 weeks
Title
c-peptide concentration in blood
Time Frame
1 year
Title
concentration of triglycerides in blood serum
Time Frame
16 weeks
Title
concentration of triglycerides in blood serum
Time Frame
1 year
Title
concentration of total cholesterol in blood
Time Frame
16 weeks
Title
concentration of total cholesterol in blood
Time Frame
1 year
Title
concentration of low density lipid (LDL) cholesterol in blood
Time Frame
16 weeks
Title
concentration of low density lipid (LDL) cholesterol in blood
Time Frame
1 year
Title
concentration of high density lipid (HDL) cholesterol in blood
Time Frame
16 weeks
Title
concentration of high density lipid (HDL) cholesterol in blood
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body mass index > 25 self reported exercise one time or less per week Exclusion Criteria: inability to use a SmartPhone illness or disabilities that preclude or hinder completion of the study cancer that makes participation impossible or exercise contraindicated (considered individually, in consultation with physician) test results indicating that study participation is unsafe participation in other studies conflicting with participation in this study symptomatic valvular, hypertrophic cardiomyopathy, unstable angina, primary pulmonary hypertension, uncontrolled hypertension, heart failure or sever arrhythmia diagnosed dementia chronic communicable infectious diseases Bariatric surgery Medication for thyroid disease, diabetes, blood pressure or lipid lowering medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrik Wisløff, prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Institutt for sirkulasjon og bildediagnostikk
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

New Health Devices to Improve Adherence to Physical Activity in Overweight Inactive Adults

We'll reach out to this number within 24 hrs