NCT02774655

Brief 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 this group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

1.1 years

First QC Date

May 13, 2016

Last Update Submit

September 21, 2017

Conditions

Cardiovascular DiseasesObesity

Keywords

healthy volunteerspatient complianceexercisemotivation

Outcome Measures

Primary Outcomes (1)

  • 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)

    1 year

Secondary Outcomes (28)

  • Cardiorespiratory fitness

    1 year

  • Cardiorespiratory fitness

    16 weeks

  • Resting blood pressure

    16 weeks

  • Resting blood pressure

    1 year

  • Resting heart rate

    16 weeks

  • +23 more secondary outcomes

Study Arms (2)

PAI APP

EXPERIMENTAL

personal activity index application

Device: Pai APP

FitBit APP

ACTIVE COMPARATOR
Device: FitBit APP

Interventions

Pai APPDEVICE

prescribed 100 PAI weekly

Also known as: personal activity Intelligence (PAI) application, Mio Fuse wristband
PAI APP
FitBit APPDEVICE

prescribed 10000 steps daily

Also known as: FitBit zip step counter
FitBit APP

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index \> 25
  • self reported exercise one time or less per week

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institutt for sirkulasjon og bildediagnostikk

Trondheim, Norway

Location

MeSH Terms

Conditions

Cardiovascular DiseasesObesityPatient ComplianceMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Ulrik Wisløff, prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2016

First Posted

May 17, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2017

Study Completion

September 1, 2017

Last Updated

September 25, 2017

Record last verified: 2017-09

Locations

NO(1)