Diastolic Dysfunction During Conservative Lifestyle Treatment

Norwegian University of Science and Technology

Status: Completed

Conditions: Obesity

Treatments: Device: Pai APP; Device: FitBit APP

Study type: Interventional

Funder types: Other

Identifiers

NCT02826122

2016/833

Details and patient eligibility

About

The Purpose of this study is to 1) investigate prevalence of diastolic dysfunction in patients with morbid obesity attending a conservative lifestyle change program, 2) investigate effects on cardiac function, cardiorespiratory Fitness, body composition, quality of life and cardiovascular risk through the program, 3) investigate feasibility of introducing two different activity monitors throughout the program, and 4) comparing compliance to activity sensor market leader FitBit Application versus Mio Pai Application

Enrollment: 57 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI > 40 kg/m2 (or BMI > 35 kg/m2 with comorbidity)
• Stable weight last Three months (≤ 2 kg variation)
• Norwegian speaking
• Smartphone

Exclusion criteria

• Other weight reduction treatment, including medication affecting appetite
• Known chronic cardiac condition
• Previous bariatric surgery
• Alcohol or other substitute abuse
• Psychiatric disorder needing treatment, including eating disorders
• Pregnancy or planned pregnancy during project period

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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57 participants in 2 patient groups

FitBit APP

Active Comparator group

Description:

FitBit Zip APP registers and give feed-back on number of steps per day, distance and calories burned.

Treatment:

Device: FitBit APP

Pai APP

Experimental group

Description:

Mio Pai APP registers duration and intensity of the Activity and give feed back as activity Points.

Treatment:

Device: Pai APP