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

Not Applicable

Completed

• Conditions: Obesity; Cardiovascular Diseases
• Interventions: Device: Pai APP; Device: FitBit APP

• Registration Number: NCT02774655
• Lead Sponsor: Norwegian University of Science and Technology

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 available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-13
• Study First Submitted QC: 2016-05-13
• Study First Posted: 2016-05-17
• Primary Completion: 2017-06
• Status Verified: 2017-09
• Study Completion: 2017-09
• Last Update Submitted: 2017-09-21
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAI APP	Pai APP	personal activity index application
FitBit APP	FitBit APP	-

Primary Outcome Measures

Name	Time	Method
The proportion of the participants obtaining 80 % or more of the prescribed physical activity for one year	1 year	Prescribed 100 PAI weekly (PAI app group), or 10 000 steps daily (step counter app)

Secondary Outcome Measures

Name	Time	Method
Cardiorespiratory fitness	16 weeks	Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany
Resting blood pressure	1 year	Left upper arm, right upper arm, orthostatic hypotension
Resting heart rate	1 year
Body mass index	1 year	Height, weight
Waist line	1 year	in centimeters
Body composition	1 year	body composition measured by bioelectrical impedance (InBody 720, BIOSPACE, Seoul, Korea)
Activity questionnaire	1 year	HUNT-1 questionnaire 2 "exercise"
glucose concentration in blood	1 year
glycosylated haemoglobin (HbA1c) concentration in blood	1 year
c-peptide concentration in blood	1 year
concentration of triglycerides in blood serum	1 year
concentration of total cholesterol in blood	1 year
concentration of low density lipid (LDL) cholesterol in blood	1 year
concentration of high density lipid (HDL) cholesterol in blood	1 year

Trial Locations

Locations (1)

Institutt for sirkulasjon og bildediagnostikk; 🇳🇴 Trondheim, Norway