Clinical trial NCT02774655: New Health Devices to Improve Adherence to Physical Activity in Overweight Inactive Adults
Official title: New Health Devices to Improve Adherence to Physical Activity in Overweight Inactive Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Obesity
Keywords: healthy volunteers
patient compliance
exercise
motivation
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: The proportion of the participants obtaining 80 % or more of the prescribed physical activity for one year
timeFrame: 1 year
Secondary outcomes:
measure: Cardiorespiratory fitness
timeFrame: 1 year
measure: Cardiorespiratory fitness
timeFrame: 16 weeks
measure: Resting blood pressure
timeFrame: 16 weeks
measure: Resting blood pressure
timeFrame: 1 year
measure: Resting heart rate
timeFrame: 16 weeks
measure: Resting heart rate
timeFrame: 1 year
measure: Body mass index
timeFrame: 16 weeks
measure: Body mass index
timeFrame: 1 year
measure: Waist line
timeFrame: 16 weeks
measure: Waist line
timeFrame: 1 year
measure: Body composition
timeFrame: 16 weeks
measure: Body composition
timeFrame: 1 year
measure: Activity questionnaire
timeFrame: 16 weeks
measure: Activity questionnaire
timeFrame: 1 year
measure: glucose concentration in blood
timeFrame: 16 weeks
measure: glucose concentration in blood
timeFrame: 1 year
measure: glycosylated haemoglobin (HbA1c) concentration in blood
timeFrame: 16 weeks
measure: glycosylated haemoglobin (HbA1c) concentration in blood
timeFrame: 1 year
measure: c-peptide concentration in blood
timeFrame: 16 weeks
measure: c-peptide concentration in blood
timeFrame: 1 year
measure: concentration of triglycerides in blood serum
timeFrame: 16 weeks
measure: concentration of triglycerides in blood serum
timeFrame: 1 year
measure: concentration of total cholesterol in blood
timeFrame: 16 weeks
measure: concentration of total cholesterol in blood
timeFrame: 1 year
measure: concentration of low density lipid (LDL) cholesterol in blood
timeFrame: 16 weeks
measure: concentration of low density lipid (LDL) cholesterol in blood
timeFrame: 1 year
measure: concentration of high density lipid (HDL) cholesterol in blood
timeFrame: 16 weeks
measure: concentration of high density lipid (HDL) cholesterol in blood
timeFrame: 1 year
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Institutt for sirkulasjon og bildediagnostikk
Study officials:
affiliation: Norwegian University of Science and Technology
name: Ulrik Wisløff, prof
role: STUDY_DIRECTOR
References: