Personal Activity Intelligence and Body Weight

NCT03260114 | Completed DMC

• 1 other identifier: 2017/319/REK midt
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight; Obesity

Keywords

Physical activity; Body weight; Obesity

Outcome Measures

Primary Outcomes (1)

• changes in body weight - BMI

  assessment of change in body weight/ BMI associated with PAI

  12 weeks

Secondary Outcomes (1)

• Cardiovascular Risk Factors

  12 weeks

Study Arms (3)

Physical activity recommendations

NO INTERVENTION

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.

PAI equal to or more than 100

ACTIVE COMPARATOR

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

Other: Personal Activity Intelligence

PAI between 50 and 99

ACTIVE COMPARATOR

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

Other: Personal Activity Intelligence

Interventions

Personal Activity Intelligence OTHER

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.

PAI between 50 and 99; PAI equal to or more than 100

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead

Study Sites (1)

St. Olav´s University Hospital

Trondheim, Sor Trondelag, 7030, Norway

Location

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity; Body Weight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Javaid Nauman, PhD

  Norwegian University of Science and Technology, Trondheim, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We aim to recruit 30 persons who meet the eligibility criteria. Eligible participants will be randomized 1:1:1 to usual care (control group), to two different PAI eHealth Programs (PAI ≥ 100 and PAI = 50 to \<100) (N = 10). To provide balance across the trial arms for sex, and age groups (\<40, 40-55, \>55 years), participants will be allocated remotely by concealed minimisation.

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 24, 2017
• Study Start: August 24, 2017
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

NO (1)