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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02774655
• Other study ID #: 2015/1750
• Status: Completed
• Phase: N/A
• First received: May 13, 2016
• Last updated: September 21, 2017
• Start date: May 2016
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Obesity
• Overweight

Intervention

Device:
• Pai APP
prescribed 100 PAI weekly
• FitBit APP
prescribed 10000 steps daily

Locations

Country	Name	City	State
Norway	Institutt for sirkulasjon og bildediagnostikk	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

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