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| Name | Class |
|---|---|
| LHL Helse | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FitBit APP | Active Comparator | FitBit Zip APP registers and give feed-back on number of steps per day, distance and calories burned. |
|
| Pai APP | Experimental | Mio Pai APP registers duration and intensity of the Activity and give feed back as activity Points. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pai APP | Device | Prescription: Target 100 PAI Points per week |
|
| Measure | Description | Time Frame |
|---|---|---|
| diastolic dysfunction | echocardiac examination at baseline assessed by GE Healthcare Vivid E9, Horten, Norway | 18 months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | measured as attrition rate, Activity sensor errors | 4 months |
| Feasibility | measured as attrition, Activity sensor errors, | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Line Oldervoll, PhD | LHL klinikkene / NTNU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LHL-Klinikkene | Røros | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36404730 | Derived | Oldervoll LM, Gjestad R, Hilmarsen C C, Ose A, Gullikstad L, Wisloff U, Kulseng B, Grimsmo J. Diastolic function and cardiovascular risk among patients with severe obesity referred to a lifestyle-program - a pilot study. Scand Cardiovasc J. 2023 Dec;57(1):8-16. doi: 10.1080/14017431.2022.2146185. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| FitBit APP | Device | Prescription: Target daily 10.000 steps |
|
|
| 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 |
| Feasibility | measured as attrition, Activity sensor errors, | 18 months |
| Compliance | actual use of Activity sensors; obtaining 80 % or more of prescribed physical Activity in home periods | 4 months |
| Compliance | actual use of Activity sensors; obtaining 80 % or more of prescribed physical Activity in home periods | 12 months |
| Compliance | actual use of Activity sensors; obtaining 80 % or more of prescribed physical Activity in home periods | 18 months |
| Meal frequency, compliance With a healthier lifestyle | HUNT 3 questionnaire | 4 months |
| Meal frequency, compliance With a healthier lifestyle | HUNT 3 questionnaire | 12 months |
| Meal frequency, compliance With a healthier lifestyle | HUNT 3 questionnaire | 18 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |