ClinicalTrials.gg
CompletedNCT03260114Updated Apr 19, 2018

Personal Activity Intelligence and Body Weight

An interventional study of Personal Activity Intelligence in Overweight and Obesity, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-19.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 38 studies in Obesity by Norwegian University of Science and Technology — none open to participants now, 3 under way, none of them phase 3. Obesity · Norwegian University of Science and Technology.

Enrollment
27th of 37
30 · median 46
Started
2017
with 3 others
No phase
37 of 38
none open now
Registered
24th of 38
by date

Among the 38 studies in Obesity by Norwegian University of Science and Technology, this one is the 27th largest by enrollment of the 37 interventional ones that give a count, is one of 4 that started in 2017, is one of 37 with no phase, and was the 24th registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

None of the 38 studies in Obesity by Norwegian University of Science and Technology is open now.

Where they have run

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Download CSVNarrow it in search →With an account: the 38 studies in Obesity by Norwegian University of Science and Technology as a file.
02

Study summary

Physical activity is one of the key strategies used by public health agencies to combat the growing burden of obesity and non-communicable diseases. Adults around the world are recommended to engage in at least 150 minutes of moderate or 75 minutes of vigorous intensity activity per week, or a combination of moderate or vigorous activity that results in approximately the same total energy expenditure. However, majority of the population does not meet the physical activity recommendation. As barriers to physical activity, people mostly cite lack of time, self-motivation and confidence in the ability to be physically active. Cardiac Exercise Research Group (CERG) at Faculty of Medicine and Health Sciences at Norwegian University of Science and Technology recently developed Personal Activity Intelligence (PAI). PAI is a result of research based on the HUNT study where more than 60 000 individuals has been monitored over a period of more than 20 years. The goal is to make PAI the new world standard of activity tracking. PAI is an individual metric that makes sense of measured heart rate data, and significantly reduces the risk of lifestyle related diseases.

The purpose of the study is to obtain new knowledge about how the use of PAI is related to body weight.

Read the detailed description

The prevalence of obesity in the Western world is continuously increasing and the amount of obese persons among the adult population in the United States is now 35%. As a result of this growing problem, it is important and necessary to find an efficient way to prevent further weight gain in the population.Physical activity is one of the key strategies used by public health agencies to combat the growing burden of non-communicable diseases. As a result adults around the world are recommended to engage in at least 150 minutes of moderate or 75 minutes of vigorous intensity activity per week, or a combination of moderate or vigorous activity that results in approximately the same total energy expenditure. However, majority of the population does not meet the physical activity recommendation. As barriers to physical activity, people mostly cite lack of time, self-motivation and confidence in the ability to be physically active.

Recently, using the HUNT study data, the Cardiac Exercise Research Group devised a simple metric termed Personal Activity Intelligence (PAI) which, using individual heart rate patterns of the body, estimates the optimal threshold of physical activity required for a specific objective: to decrease risk of premature death in an individual from the general population. The idea is to keep the weekly PAI score above 100. Since PAI is a personalized reflection of the body's response to physical activity based on heart rate, PAI score of 100 is specific to an individual. For example, a 100 PAI for a fit person is not the same as 100 PAI for an unfit person. PAI can be accumulated over a course of one week using physical activity of personal preference (i.e. walking, swimming, dancing, playing with grandchildren etc.) and allows for days with no activity as long as they are followed up by days of higher activity. However, the optimal amount and intensity (i.e. the number of PAI) of physical activity that would help for weight gain prevention still remains to be determined.

03

Conditions studied

  • Overweight
  • Obesity

Browse trials for

Keywords

  • Physical activity
  • Body weight
  • Obesity
04

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 30 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 495 studies on the registry; 48 are open to participants now.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

The inclusion criteria for clinical study is healthy participants with a > 25 and \< 40.

Exclusion criteria

Exclusion Criteria:

We will exclude people with severe illness or disabilities that preclude or hinder completion of the study or make exercise contradicted, uncontrolled hypertension, arrhythmias or angina, participation in conflicting interventions, primary pulmonary hypertension, diagnosed dementia or chronic communicable infectious diseases.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

06

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • No intervention
    Physical activity recommendations

    Participants in this group will be advised to engage in physical activity recommendations from health authorities, i.e., 150 minutes per week of moderate intensity activity or 75 minutes per week of vigourous intensity activity or combination of both that results in same caloric expenditure.

  • Active comparator
    PAI equal to or more than 100

    Participants in this group will be advised to obtain a PAI score of 100 or more over a week.

    Other: Personal Activity Intelligence

  • Active comparator
    PAI between 50 and 99

    Participants in this group will be advised to obtain a PAI score between 50-99 over a week.

    Other: Personal Activity Intelligence

Interventions

  • OtherPersonal Activity Intelligence

    Participants randomized to the PAI eHealth program will be given a Mio Slice wristband (http://www.mioglobal.com/pai/), to measure the heart rate for calculating PAI. A weekly PAI of 100 can be achieved by a combination of different exercise intensities and the participants will, at any time, get information from the device (Mio Slice) (and the PAI App if they chose to use that as well) regarding how many minutes at specified heart rates is needed to achieve the weekly goal of 100 PAI. Participants will receive automatic feedback on a daily basis, and data will be automatically recorded on a secured server.

07

What researchers measure

Primary outcomes

  1. changes in body weight - BMI

    assessment of change in body weight/ BMI associated with PAI

    Time frame: 12 weeks

Secondary outcomes

  1. Cardiovascular Risk Factors

    change in CVD risk factors associated with PAI

    Time frame: 12 weeks

08

Study locations

1 site
  • St. Olav´s University Hospital
    Trondheim, Sor Trondelag 7030, Norway
09

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2017 to primary completion in Mar 2018, 7 months.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 7 months is below that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2017
First posted
Aug 24, 2017
StartActual
Aug 24, 2017
Primary completionActual
Mar 30, 2018
CompletionActual
Mar 30, 2018
Last update
Apr 19, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03260114
Responsible party
Sponsor
First posted
Aug 24, 2017
Start date
Aug 24, 2017
Primary completion
Mar 30, 2018
Completion
Mar 30, 2018
Last update
Apr 19, 2018

Study contacts

Javaid Nauman, PhD
principal investigator · Norwegian University of Science and Technology, Trondheim, Norway

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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