Cardiovascular DiseasesNCT02774655
New Health Devices to Improve Adherence to Physical Activity in Overweight Inactive Adults
A study testing Pai APP and FitBit APP in people with Cardiovascular Diseases and Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Cardiovascular Diseases, Obesity
- What is being tested?
- Pai APP and FitBit APP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- May 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index > 25
- self reported exercise one time or less per week
Who cannot join
- 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
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- diagnosed dementia
- chronic communicable infectious diseases
- Bariatric surgery
- Medication for thyroid disease, diabetes, blood pressure or lipid lowering medication
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cardiovascular Diseases, Obesity
- Being tested
- Pai APP, FitBit APP
- Keywords
- healthy volunteers, patient compliance, exercise, motivation
- Medical subject headings
- Cardiovascular Diseases, Obesity, Patient Compliance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pai APPDevice
Also called personal activity Intelligence (PAI) application, Mio Fuse wristband
prescribed 100 PAI weekly
FitBit APPDevice
Also called FitBit zip step counter
prescribed 10000 steps daily
| Study group | Role | What they receive |
|---|---|---|
| PAI APP | Experimental | personal activity index application Receives: Device: Pai APP |
| FitBit APP | Active comparator | Not described Receives: Device: FitBit APP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary outcomes (28)
Cardiorespiratory fitness
Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany
Measured: 1 year
Cardiorespiratory fitness
Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany
Measured: 16 weeks
Resting blood pressure
Left upper arm, right upper arm, orthostatic hypotension
Measured: 16 weeks
Resting blood pressure
Left upper arm, right upper arm, orthostatic hypotension
Measured: 1 year
Resting heart rate
Measured: 16 weeks
Resting heart rate
Measured: 1 year
Body mass index
Height, weight
Measured: 16 weeks
Body mass index
Height, weight
Measured: 1 year
Waist line
in centimeters
Measured: 16 weeks
Waist line
in centimeters
Measured: 1 year
Body composition
body composition measured by bioelectrical impedance (InBody 720, BIOSPACE, Seoul, Korea)
Measured: 16 weeks
Body composition
body composition measured by bioelectrical impedance (InBody 720, BIOSPACE, Seoul, Korea)
Measured: 1 year
Activity questionnaire
HUNT-1 questionnaire 2 "exercise"
Measured: 16 weeks
Activity questionnaire
HUNT-1 questionnaire 2 "exercise"
Measured: 1 year
glucose concentration in blood
Measured: 16 weeks
glucose concentration in blood
Measured: 1 year
glycosylated haemoglobin (HbA1c) concentration in blood
Measured: 16 weeks
glycosylated haemoglobin (HbA1c) concentration in blood
Measured: 1 year
c-peptide concentration in blood
Measured: 16 weeks
c-peptide concentration in blood
Measured: 1 year
concentration of triglycerides in blood serum
Measured: 16 weeks
concentration of triglycerides in blood serum
Measured: 1 year
concentration of total cholesterol in blood
Measured: 16 weeks
concentration of total cholesterol in blood
Measured: 1 year
concentration of low density lipid (LDL) cholesterol in blood
Measured: 16 weeks
concentration of low density lipid (LDL) cholesterol in blood
Measured: 1 year
concentration of high density lipid (HDL) cholesterol in blood
Measured: 16 weeks
concentration of high density lipid (HDL) cholesterol in blood
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrik Wisløff, prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774655
- Sponsor's protocol ID
- 2015/1750
- Status last verified
- Sep 2017
- First submitted
- 13 May 2016
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Health Devices to Improve Adherence to Physical Activity in Overweight Inactive Adults
- ClinicalTrials.gov ID
- NCT02774655
- Acronym / sponsor ID
- 2015/1750
- Conditions
- Cardiovascular Diseases, Obesity
- Keywords
- healthy volunteers, patient compliance, exercise, motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAI APP | Experimental | Device: Pai APPpersonal activity index application |
| FitBit APP | Active comparator | Device: FitBit APP |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index > 25
- self reported exercise one time or less per week
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pai APPAlso: personal activity Intelligence (PAI) application, Mio Fuse wristbandprescribed 100 PAI weekly | Device | PAI APP |
| FitBit APPAlso: FitBit zip step counterprescribed 10000 steps daily | Device | FitBit APP |
Primary outcome
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)
28 secondary outcomes
Cardiorespiratory fitness
Time frame: 1 year
Cardiorespiratory fitness
Time frame: 16 weeks
Resting blood pressure
Time frame: 16 weeks
Resting blood pressure
Time frame: 1 year
Resting heart rate
Time frame: 16 weeks
Resting heart rate
Time frame: 1 year
Body mass index
Time frame: 16 weeks
Body mass index
Time frame: 1 year
Waist line
Time frame: 16 weeks
Waist line
Time frame: 1 year
Body composition
Time frame: 16 weeks
Body composition
Time frame: 1 year
Activity questionnaire
Time frame: 16 weeks
Activity questionnaire
Time frame: 1 year
glucose concentration in blood
Time frame: 16 weeks
glucose concentration in blood
Time frame: 1 year
glycosylated haemoglobin (HbA1c) concentration in blood
Time frame: 16 weeks
glycosylated haemoglobin (HbA1c) concentration in blood
Time frame: 1 year
c-peptide concentration in blood
Time frame: 16 weeks
c-peptide concentration in blood
Time frame: 1 year
concentration of triglycerides in blood serum
Time frame: 16 weeks
concentration of triglycerides in blood serum
Time frame: 1 year
concentration of total cholesterol in blood
Time frame: 16 weeks
concentration of total cholesterol in blood
Time frame: 1 year
concentration of low density lipid (LDL) cholesterol in blood
Time frame: 16 weeks
concentration of low density lipid (LDL) cholesterol in blood
Time frame: 1 year
concentration of high density lipid (HDL) cholesterol in blood
Time frame: 16 weeks
concentration of high density lipid (HDL) cholesterol in blood
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrik Wisløff, prof study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pai APP and FitBit APP in people with Cardiovascular Diseases and Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of the participants obtaining 80 % or more of the prescribed physical activity for one year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.