New Health Devices to Improve Adherence to Physical Activ... | NCT02774655

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

NCT02774655

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Sep 25, 2017Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Cardiovascular Diseases
Obesity

Interventions

Pai APP
FitBit APP

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016Actual

Primary Completion Date

Jun 2017Actual

Completion Date

Sep 2017Actual

First Submitted Date

May 13, 2016

First Submission Date that Met QC Criteria

May 13, 2016

First Posted Date

May 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2017

Last Update Posted Date

Sep 25, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PAI APP	Experimental	personal activity index application	Device: Pai APP
FitBit APP	Active Comparator		Device: FitBit APP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pai APP	Device	prescribed 100 PAI weekly	PAI APP	personal activity Intelligence (PAI) application

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Cardiorespiratory fitness	Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany	1 year
Cardiorespiratory fitness	Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ulrik Wisløff, prof	Norwegian University of Science and Technology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institutt for sirkulasjon og bildediagnostikk		Trondheim			Norway

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases
D009765	Obesity
D010349	Patient Compliance
D009043	Motor Activity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided