Obesity
Conditions
Brief summary
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
Interventions
DEVICEPai APP
Prescription: Target 100 PAI Points per week
DEVICEFitBit APP
Prescription: Target daily 10.000 steps
Sponsors
LHL Helse
Norwegian University of Science and Technology
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diastolic dysfunction | 18 months | echocardiac examination at baseline assessed by GE Healthcare Vivid E9, Horten, Norway |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HDL concentration in blood | 4 months | High Density Cholesterol |
| Apo-B concentration in blood serum | 4 months | Apolipoprotein B |
| NT-ProBNP concentration in plasma | 4 months | N-Terminal Brain Natriuretic Peptide |
| Lp(a) concentration in blood serum | 4 months | Lipoprotein(a) |
| diastolic function | 4 months | echocardiac examination assessed by GE Healthcare Vivid E9, Horten, Norway |
| Cardiorespiratory fitness | 4 months | Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany |
| Body composition | 4 months | Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea) |
| Body Mass Index | 4 months | Weight derived by squared height |
| Waist line | 4 months | tape measure in centimeters |
| Physical Activity Questionnaire | 4 months | HUNT 1 physical activity questionnaire |
| Quality of life | 4 months | Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin |
| Symptoms of anxiety and depression | 4 months | Hospital Anxiety and Depression Scale; Zigmond & Snaith |
| Glucose concentration in blood | 4 months | — |
| Glycosylated haemoglobin (HbA1c) concentration in blood | 4 months | — |
| LDL concentration in blood | 4 months | Low Density Cholesterol |
| Concentration of total cholesterol in blood | 4 months | — |
| Concentration of triglycerides in blood serum | 4 months | — |
| Concentration of HS-CRP in blood serum | 4 months | High Sensitive C-reactive protein |
| C-peptide concentration in blood | 4 months | — |
| Leukocyte concentration in blood | 4 months | — |
| Potassium (K) concentration in blood | 4 months | — |
| Sodium (Na) concentration in blood | 4 months | — |
| Creatinine concentration in blood | 4 months | — |
| Apo-A concentration in blood serum | 4 months | Apolipoprotein A |
Other
| Measure | Time frame | Description |
|---|---|---|
| Meal frequency, compliance With a healthier lifestyle | 4 months | HUNT 3 questionnaire |
| Compliance | 4 months | actual use of Activity sensors; obtaining 80 % or more of prescribed physical Activity in home periods |
| Feasibility | 4 months | measured as attrition rate, Activity sensor errors |
Countries
Norway
Outcome results
None listed