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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiovascular Diseases, Obesity

Intervention / Treatment
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* Device: Pai APP
* Device: FitBit APP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAI APP<br>personal activity index application | Device: Pai APP<br>* prescribed 100 PAI weekly<br>* Other names: Mio Fuse wristband;|
| Active Comparator: FitBit APP<br> | Device: FitBit APP<br>* prescribed 10000 steps daily<br>* Other names: FitBit zip step counter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | 16 weeks | 
| Resting blood pressure | Left upper arm, right upper arm, orthostatic hypotension | 16 weeks | 
| Resting blood pressure | Left upper arm, right upper arm, orthostatic hypotension | 1 year | 
| Resting heart rate |  | 16 weeks | 
| Resting heart rate |  | 1 year | 
| Body mass index | Height, weight | 16 weeks | 
| Body mass index | Height, weight | 1 year | 
| Waist line | in centimeters | 16 weeks | 
| Waist line | in centimeters | 1 year | 
| Body composition | body composition measured by bioelectrical impedance (InBody 720, BIOSPACE, Seoul, Korea) | 16 weeks | 
| Body composition | body composition measured by bioelectrical impedance (InBody 720, BIOSPACE, Seoul, Korea) | 1 year | 
| Activity questionnaire | HUNT-1 questionnaire 2 exercise | 16 weeks | 
| Activity questionnaire | HUNT-1 questionnaire 2 exercise | 1 year | 
| glucose concentration in blood |  | 16 weeks | 
| glucose concentration in blood |  | 1 year | 
| glycosylated haemoglobin (HbA1c) concentration in blood |  | 16 weeks | 
| glycosylated haemoglobin (HbA1c) concentration in blood |  | 1 year | 
| c-peptide concentration in blood |  | 16 weeks | 
| c-peptide concentration in blood |  | 1 year | 
| concentration of triglycerides in blood serum |  | 16 weeks | 
| concentration of triglycerides in blood serum |  | 1 year | 
| concentration of total cholesterol in blood |  | 16 weeks | 
| concentration of total cholesterol in blood |  | 1 year | 
| concentration of low density lipid (LDL) cholesterol in blood |  | 16 weeks | 
| concentration of low density lipid (LDL) cholesterol in blood |  | 1 year | 
| concentration of high density lipid (HDL) cholesterol in blood |  | 16 weeks | 
| concentration of high density lipid (HDL) cholesterol in blood |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy volunteers, patient compliance, exercise, motivation