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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02774655
Enrollment
60
Registered
2016-05-17
Start date
2016-05-31
Completion date
2017-09-30
Last updated
2017-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Obesity

Keywords

motivation, healthy volunteers, patient compliance, exercise

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.

Interventions

DEVICEPai APP

prescribed 100 PAI weekly

prescribed 10000 steps daily

Sponsors

Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The proportion of the participants obtaining 80 % or more of the prescribed physical activity for one year1 yearPrescribed 100 PAI weekly (PAI app group), or 10 000 steps daily (step counter app)

Secondary

MeasureTime frameDescription
Cardiorespiratory fitness1 yearPeak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany
Resting blood pressure16 weeksLeft upper arm, right upper arm, orthostatic hypotension
Resting heart rate16 weeks
Body mass index16 weeksHeight, weight
Waist line16 weeksin centimeters
Body composition16 weeksbody composition measured by bioelectrical impedance (InBody 720, BIOSPACE, Seoul, Korea)
concentration of total cholesterol in blood16 weeks
glucose concentration in blood16 weeks
glycosylated haemoglobin (HbA1c) concentration in blood16 weeks
c-peptide concentration in blood16 weeks
concentration of triglycerides in blood serum16 weeks
concentration of low density lipid (LDL) cholesterol in blood16 weeks
concentration of high density lipid (HDL) cholesterol in blood16 weeks
Activity questionnaire16 weeksHUNT-1 questionnaire 2 exercise

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026