MedDataX Logo

New Health Devices to Improve Adherence to Physical Activity in Overweight Inactive Adults

NCT ID: NCT02774655

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Diseases Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PAI APP

personal activity index application

Group Type EXPERIMENTAL

Pai APP

Intervention Type DEVICE

prescribed 100 PAI weekly

FitBit APP

Group Type ACTIVE_COMPARATOR

FitBit APP

Intervention Type DEVICE

prescribed 10000 steps daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pai APP

prescribed 100 PAI weekly

Intervention Type DEVICE

FitBit APP

prescribed 10000 steps daily

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

personal activity Intelligence (PAI) application Mio Fuse wristband FitBit zip step counter

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ulrik Wisløff, prof

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institutt for sirkulasjon og bildediagnostikk

Trondheim, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015/1750

Identifier Type: -

Identifier Source: org_study_id