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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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