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

September 21, 2017 updated by: Norwegian University of Science and Technology
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • Institutt for sirkulasjon og bildediagnostikk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PAI APP
personal activity index application
Device: Pai APP
prescribed 100 PAI weekly
Other Names:
  • personal activity Intelligence (PAI) application
  • Mio Fuse wristband
ACTIVE_COMPARATOR: FitBit APP
Device: FitBit APP
prescribed 10000 steps daily
Other Names:
  • FitBit zip step counter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of the participants obtaining 80 % or more of the prescribed physical activity for one year
Time Frame: 1 year
Prescribed 100 PAI weekly (PAI app group), or 10 000 steps daily (step counter app)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiorespiratory fitness
Time Frame: 1 year
Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany
1 year
Cardiorespiratory fitness
Time Frame: 16 weeks
Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany
16 weeks
Resting blood pressure
Time Frame: 16 weeks
Left upper arm, right upper arm, orthostatic hypotension
16 weeks
Resting blood pressure
Time Frame: 1 year
Left upper arm, right upper arm, orthostatic hypotension
1 year
Resting heart rate
Time Frame: 16 weeks
16 weeks
Resting heart rate
Time Frame: 1 year
1 year
Body mass index
Time Frame: 16 weeks
Height, weight
16 weeks
Body mass index
Time Frame: 1 year
Height, weight
1 year
Waist line
Time Frame: 16 weeks
in centimeters
16 weeks
Waist line
Time Frame: 1 year
in centimeters
1 year
Body composition
Time Frame: 16 weeks
body composition measured by bioelectrical impedance (InBody 720, BIOSPACE, Seoul, Korea)
16 weeks
Body composition
Time Frame: 1 year
body composition measured by bioelectrical impedance (InBody 720, BIOSPACE, Seoul, Korea)
1 year
Activity questionnaire
Time Frame: 16 weeks
HUNT-1 questionnaire 2 "exercise"
16 weeks
Activity questionnaire
Time Frame: 1 year
HUNT-1 questionnaire 2 "exercise"
1 year
glucose concentration in blood
Time Frame: 16 weeks
16 weeks
glucose concentration in blood
Time Frame: 1 year
1 year
glycosylated haemoglobin (HbA1c) concentration in blood
Time Frame: 16 weeks
16 weeks
glycosylated haemoglobin (HbA1c) concentration in blood
Time Frame: 1 year
1 year
c-peptide concentration in blood
Time Frame: 16 weeks
16 weeks
c-peptide concentration in blood
Time Frame: 1 year
1 year
concentration of triglycerides in blood serum
Time Frame: 16 weeks
16 weeks
concentration of triglycerides in blood serum
Time Frame: 1 year
1 year
concentration of total cholesterol in blood
Time Frame: 16 weeks
16 weeks
concentration of total cholesterol in blood
Time Frame: 1 year
1 year
concentration of low density lipid (LDL) cholesterol in blood
Time Frame: 16 weeks
16 weeks
concentration of low density lipid (LDL) cholesterol in blood
Time Frame: 1 year
1 year
concentration of high density lipid (HDL) cholesterol in blood
Time Frame: 16 weeks
16 weeks
concentration of high density lipid (HDL) cholesterol in blood
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2016

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

September 1, 2017

Study Registration Dates

First Submitted

May 13, 2016

First Submitted That Met QC Criteria

May 13, 2016

First Posted (ESTIMATE)

May 17, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 21, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/1750

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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