ObesityNCT03336047
The Effect of Personal Activity Intelligence Versus 10,000 Steps Daily on Cardiorespiratory Fitness
A study testing personal activity intelligence and 10,000 steps daily in people with Obesity and Physical Activity, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
A high physical fitness can prevent cardiovascular disease. Which form of exercise training is efficient at improving fitness is well known. The challenge is to get people to do it. Personal activity intelligence (PAI) is an algorithm developed for this challenge. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Obesity, Physical Activity
- What is being tested?
- personal activity intelligence and 10,000 steps daily
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNorway
- Study dates
- 15 Nov 2017to 15 Feb 2018
- 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 (BMI) > 25
- Low physical activity (less than 50 PAI points calculated from a questionnaire)
Who cannot join
- Cancer diagnosis
- Cardiac arrhythmia
- Angina
- Previous myocardial infarction
- lung disease
- heart disease
Show all 11Show fewer
- uncontrolled hypertension
- kidney disease
- orthopedic or neurological limitations
- planned surgery during the intervention
- participation in other research studies conflicting with the current study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Personal Activity Intelligence Versus 10,000 Steps Daily on Cardiorespiratory Fitness in Overweight and Obese
A high physical fitness can prevent cardiovascular disease. Which form of exercise training is efficient at improving fitness is well known. The challenge is to get people to do it. Personal activity intelligence (PAI) is an algorithm developed for this challenge. It gives a score that tells the users whether they are active enough to achieve the maximum health benefit of exercise based on their heart rate. It has been shown that people who obtain 100 PAI a week have less cardiovascular disease, but intervention studies showing that PAI can improve physical fitness are so far lacking.
Step counters have received a lot of attention and 10 000 steps a day is a common recommendation, but little is known about the physiological adaptations to this intervention.
This study will compare the effect of physical activity with a value of 100 PAI points a week with 10 000 steps a day in healthy, but overweight (body mass index > 25) participants between 30 and 50 years of age.
- Conditions
- Obesity, Physical Activity
- Being tested
- personal activity intelligence, 10,000 steps daily
- Keywords
- Exercise, Actigraphy, Prevention and Control, Cardiorespiratory Fitness
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personal activity intelligenceBehavioural
Also called PAI
Participants randomized to the PAI intervention will receive a Mio Slice fitness bracelet and asked to install the Mio Pai 2.0 app on their smart phone. This tracks their fitness score based on the PAI algorithm where the goal is to maintain 100 PAI points a week. PAI is earned incrementally based on time spent in three different heart rate zones, low, medium and high intensity. PAI is recorded every day and added to the weekly total and the PAI earned on the same day the previous week is deleted (on Tuesday, the PAI earned the previous Tuesday will disappear).
Participants will be encouraged to maintain 100 PAI during the 8 weeks intervention by telephone messages (sms).
10,000 steps dailyBehavioural
Participants randomized to the 10,000 step intervention will receive a fit bit zip step counter and asked to obtain 10.000 steps per day. Participants will be encouraged to obtain 10.000 steps per day by telephone messages (sms).
| Study group | Role | What they receive |
|---|---|---|
| 10,000 steps daily | Active comparator | Subjects will be encouraged to obtain 10 000 steps a day, monitored by a step counter (fit bit zip) Receives: Behavioral: 10,000 steps daily |
| using personal activity intelligence | Experimental | Subjects will be encouraged to obtain 100 PAI points per week, monitored by Mio Slice and the Mio Pai 2.0 smart phone application Receives: Behavioral: personal activity intelligence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen uptake
The highest amount of oxygen the body can take up, achieved at maximal exercise at the end of an incremental treadmill test measured through ergospirometry. The difference between the two groups post-intervention will be used, while controlling for a pre-intervention value.
Measured: After the intervention period (8 weeks)
Secondary outcomes (1)
Body composition
Body mass, fat mass and lean mass will be measured using a bio impedance analysis which weighs the participants and uses bio impedance to also assess fat mass and lean mass.
The difference between the two groups post-intervention will be used, while controlling for a pre-intervention value.
Measured: After intervention period (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start15 Nov 2017
- Primary completion15 Feb 2018
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fredrik Hjulstad Bækkerud, Principal investigator, Norwegian University of Science and TechnologyUlrik Wisløff, phd prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336047
- Sponsor's protocol ID
- 2017/1211
- Status last verified
- Aug 2020
- First submitted
- 1 Nov 2017
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Personal Activity Intelligence Versus 10,000 Steps Daily on Cardiorespiratory Fitness in Overweight and Obese
- ClinicalTrials.gov ID
- NCT03336047
- Acronym / sponsor ID
- 2017/1211
- Conditions
- Obesity, Physical Activity
- Keywords
- Exercise, Actigraphy, Prevention and Control, Cardiorespiratory Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 8 Nov 2017 (actual)
- 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.
A high physical fitness can prevent cardiovascular disease. Which form of exercise training is efficient at improving fitness is well known. The challenge is to get people to do it. Personal activity intelligence (PAI) is an algorithm developed for this challenge. It gives a score that tells the users whether they are active enough to achieve the maximum health benefit of exercise based on their heart rate. It has been shown that people who obtain 100 PAI a week have less cardiovascular disease, but intervention studies showing that PAI can improve physical fitness are so far lacking.
Step counters have received a lot of attention and 10 000 steps a day is a common recommendation, but little is known about the physiological adaptations to this intervention.
This study will compare the effect of physical activity with a value of 100 PAI points a week with 10 000 steps a day in healthy, but overweight (body mass index > 25) participants between 30 and 50 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10,000 steps daily | Active comparator | Behavioral: 10,000 steps dailySubjects will be encouraged to obtain 10 000 steps a day, monitored by a step counter (fit bit zip) |
| using personal activity intelligence | Experimental | Behavioral: personal activity intelligenceSubjects will be encouraged to obtain 100 PAI points per week, monitored by Mio Slice and the Mio Pai 2.0 smart phone application |
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 (BMI) > 25
- Low physical activity (less than 50 PAI points calculated from a questionnaire)
Key exclusion criteria (11 listed)
- Cancer diagnosis
- Cardiac arrhythmia
- Angina
- Previous myocardial infarction
- lung disease
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 |
|---|---|---|
| personal activity intelligenceAlso: PAIParticipants randomized to the PAI intervention will receive a Mio Slice fitness bracelet and asked to install the Mio Pai 2.0 app on their smart phone. This tracks their fitness score based on the PAI algorithm where the goal is to maintain 100 PAI points a week. PAI is earned incrementally based on time spent in three different heart rate zones, low, medium and high intensity. PAI is recorded every day and added to the weekly total and the PAI earned on the same day the previous week is deleted (on Tuesday, the PAI earned the previous Tuesday will disappear). Participants will be encouraged to maintain 100 PAI during the 8 weeks intervention by telephone messages (sms). | Behavioural | using personal activity intelligence |
| 10,000 steps dailyParticipants randomized to the 10,000 step intervention will receive a fit bit zip step counter and asked to obtain 10.000 steps per day. Participants will be encouraged to obtain 10.000 steps per day by telephone messages (sms). | Behavioural | 10,000 steps daily |
Primary outcome
Maximal oxygen uptake
Time frame: After the intervention period (8 weeks)
The highest amount of oxygen the body can take up, achieved at maximal exercise at the end of an incremental treadmill test measured through ergospirometry. The difference between the two groups post-intervention will be used, while controlling for a pre-intervention value.
1 secondary outcome
Body composition
Time frame: After intervention period (8 weeks)
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 4 Aug 2020.
Related trials for Obesity
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
Not yet recruiting
High-Flow Nasal Oxygen-Assisted Deep Extubation Versus Awake Extubation in Morbidly Obese Patients
Deep Tracheal Extubation
Active, not recruiting
Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
Obesity, Weight Loss
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
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.
Fredrik Hjulstad Bækkerud principal investigator
Norwegian University of Science and Technology
Ulrik Wisløff, phd 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 personal activity intelligence and 10,000 steps daily in people with Obesity and Physical Activity, 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 11 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 4 Aug 2020. 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?
Maximal oxygen uptake (time frame: After the intervention period (8 weeks)). 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 4 Aug 2020.