Diastolic Dysfunction During Conservative Lifestyle Treatment

Study Overview
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Brief Summary
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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

Official Title
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Prevalence of Diastolic Dysfunction and Effects of Conservative Lifestyle Treatment in Patients With Morbid Obesity

Conditions
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FitBit APP<br>FitBit Zip APP registers and give feed-back on number of steps per day, distance and calories burned. | Device: FitBit APP<br>* Prescription: Target daily 10.000 steps<br>* Other names: FitBit Zip;|
| Experimental: Pai APP<br>Mio Pai APP registers duration and intensity of the Activity and give feed back as activity Points. | Device: Pai APP<br>* Prescription: Target 100 PAI Points per week<br>* Other names: MIO Fuse Wristband;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diastolic dysfunction | echocardiac examination at baseline assessed by GE Healthcare Vivid E9, Horten, Norway | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diastolic function | echocardiac examination assessed by GE Healthcare Vivid E9, Horten, Norway | 4 months | 
| diastolic function | echocardiac examination assessed by GE Healthcare Vivid E9, Horten, Norway | 12 months | 
| Cardiorespiratory fitness | Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany | 4 months | 
| Cardiorespiratory fitness | Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany | 12 months | 
| Cardiorespiratory fitness | Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany | 18 months | 
| Body composition | Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea) | 4 months | 
| Body composition | Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea) | 12 months | 
| Body composition | Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea) | 18 months | 
| Body Mass Index | Weight derived by squared height | 4 months | 
| Body Mass Index | Weight derived by squared height | 12 months | 
| Body Mass Index | Weight derived by squared height | 18 months | 
| Waist line | tape measure in centimeters | 4 months | 
| Waist line | tape measure in centimeters | 12 months | 
| Waist line | tape measure in centimeters | 18 months | 
| Physical Activity Questionnaire | HUNT 1 physical activity questionnaire | 4 months | 
| Physical Activity Questionnaire | HUNT 1 physical activity questionnaire | 12 months | 
| Physical Activity Questionnaire | HUNT 1 physical activity questionnaire | 18 months | 
| Quality of life | Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin | 4 months | 
| Quality of life | Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin | 12 months | 
| Quality of life | Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin | 18 months | 
| Symptoms of anxiety and depression | Hospital Anxiety and Depression Scale; Zigmond & Snaith | 4 months | 
| Symptoms of anxiety and depression | Hospital Anxiety and Depression Scale; Zigmond & Snaith | 12 months | 
| Symptoms of anxiety and depression | Hospital Anxiety and Depression Scale; Zigmond & Snaith | 18 months | 
| Glucose concentration in blood |  | 4 months | 
| Glucose concentration in blood |  | 12 months | 
| Glucose concentration in blood |  | 18 months | 
| Glycosylated haemoglobin (HbA1c) concentration in blood |  | 4 months | 
| Glycosylated haemoglobin (HbA1c) concentration in blood |  | 12 months | 
| Glycosylated haemoglobin (HbA1c) concentration in blood |  | 18 months | 
| LDL concentration in blood | Low Density Cholesterol | 4 months | 
| LDL concentration in blood | Low Density Cholesterol | 12 months | 
| LDL concentration in blood | Low Density Cholesterol | 18 months | 
| HDL concentration in blood | High Density Cholesterol | 4 months | 
| HDL concentration in blood | High Density Cholesterol | 12 months | 
| HDL concentration in blood | High Density Cholesterol | 18 months | 
| Concentration of total cholesterol in blood |  | 4 months | 
| Concentration of total cholesterol in blood |  | 12 months | 
| Concentration of total cholesterol in blood |  | 18 months | 
| Concentration of triglycerides in blood serum |  | 4 months | 
| Concentration of triglycerides in blood serum |  | 12 months | 
| Concentration of triglycerides in blood serum |  | 18 months | 
| Concentration of HS-CRP in blood serum | High Sensitive C-reactive protein | 4 months | 
| Concentration of HS-CRP in blood serum | High Sensitive C-reactive protein | 12 months | 
| Concentration of HS-CRP in blood serum | High Sensitive C-reactive protein | 18 months | 
| C-peptide concentration in blood |  | 4 months | 
| C-peptide concentration in blood |  | 12 months | 
| C-peptide concentration in blood |  | 18 months | 
| Leukocyte concentration in blood |  | 4 months | 
| Leukocyte concentration in blood |  | 12 months | 
| Leukocyte concentration in blood |  | 18 months | 
| Potassium (K) concentration in blood |  | 4 months | 
| Potassium (K) concentration in blood |  | 12 months | 
| Potassium (K) concentration in blood |  | 18 months | 
| Sodium (Na) concentration in blood |  | 4 months | 
| Sodium (Na) concentration in blood |  | 12 months | 
| Sodium (Na) concentration in blood |  | 18 months | 
| Creatinine concentration in blood |  | 4 months | 
| Creatinine concentration in blood |  | 12 months | 
| Creatinine concentration in blood |  | 18 months | 
| Apo-A concentration in blood serum | Apolipoprotein A | 4 months | 
| Apo-A concentration in blood serum | Apolipoprotein A | 12 months | 
| Apo-A concentration in blood serum | Apolipoprotein A | 18 months | 
| Apo-B concentration in blood serum | Apolipoprotein B | 4 months | 
| Apo-B concentration in blood serum | Apolipoprotein B | 12 months | 
| Apo-B concentration in blood serum | Apolipoprotein B | 18 months | 
| NT-ProBNP concentration in plasma | N-Terminal Brain Natriuretic Peptide | 4 months | 
| NT-ProBNP concentration in plasma | N-Terminal Brain Natriuretic Peptide | 12 months | 
| NT-ProBNP concentration in plasma | N-Terminal Brain Natriuretic Peptide | 18 months | 
| Lp(a) concentration in blood serum | Lipoprotein(a) | 4 months | 
| Lp(a) concentration in blood serum | Lipoprotein(a) | 12 months | 
| Lp(a) concentration in blood serum | Lipoprotein(a) | 18 months |