Diastolic Dysfunction During Conservative Lifestyle Treatment

Norwegian University of Science and Technology57 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Obesity

Interventions

Pai APPDEVICE

Prescription: Target 100 PAI Points per week

FitBit APPDEVICE

Prescription: Target daily 10.000 steps

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

LHL-Klinikkene

Røros, Norway

Outcomes

Primary Outcomes

diastolic dysfunction

echocardiac examination at baseline assessed by GE Healthcare Vivid E9, Horten, Norway

Time frame: 18 months

Secondary Outcomes

diastolic function

echocardiac examination assessed by GE Healthcare Vivid E9, Horten, Norway

Time frame: 4 months

diastolic function

echocardiac examination assessed by GE Healthcare Vivid E9, Horten, Norway

Time frame: 12 months

Cardiorespiratory fitness

Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany

Time frame: 4 months

Cardiorespiratory fitness

Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany

Time frame: 12 months

Cardiorespiratory fitness

Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany

Time frame: 18 months

Body composition

Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea)

Time frame: 4 months

Body composition

Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea)

Time frame: 12 months

Data from ClinicalTrials.gov

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