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Trial record 1 of 1 for:    NCT02826122
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Diastolic Dysfunction During Conservative Lifestyle Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02826122
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : August 27, 2018
Sponsor:
Collaborator:
LHL Helse
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Study Description
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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

Condition or disease Intervention/treatment Phase
Obesity Device: Pai APP Device: FitBit APP Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prevalence of Diastolic Dysfunction and Effects of Conservative Lifestyle Treatment in Patients With Morbid Obesity
Actual Study Start Date : August 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: FitBit APP
FitBit Zip APP registers and give feed-back on number of steps per day, distance and calories burned.
 Device: FitBit APP
Prescription: Target daily 10.000 steps
Other Name: FitBit Zip
Experimental: Pai APP
Mio Pai APP registers duration and intensity of the Activity and give feed back as activity Points.
 Device: Pai APP
Prescription: Target 100 PAI Points per week
Other Names:
  • Personal Activity Intelligence (PAI) application
  • MIO Fuse Wristband


Outcome Measures
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Primary Outcome Measures :
  1. diastolic dysfunction [ Time Frame: 18 months ]
    echocardiac examination at baseline assessed by GE Healthcare Vivid E9, Horten, Norway


Secondary Outcome Measures :
  1. diastolic function [ Time Frame: 4 months ]
    echocardiac examination assessed by GE Healthcare Vivid E9, Horten, Norway

  2. diastolic function [ Time Frame: 12 months ]
    echocardiac examination assessed by GE Healthcare Vivid E9, Horten, Norway

  3. Cardiorespiratory fitness [ Time Frame: 4 months ]
    Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany

  4. Cardiorespiratory fitness [ Time Frame: 12 months ]
    Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany

  5. Cardiorespiratory fitness [ Time Frame: 18 months ]
    Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany

  6. Body composition [ Time Frame: 4 months ]
    Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea)

  7. Body composition [ Time Frame: 12 months ]
    Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea)

  8. Body composition [ Time Frame: 18 months ]
    Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea)

  9. Body Mass Index [ Time Frame: 4 months ]
    Weight derived by squared height

  10. Body Mass Index [ Time Frame: 12 months ]
    Weight derived by squared height

  11. Body Mass Index [ Time Frame: 18 months ]
    Weight derived by squared height

  12. Waist line [ Time Frame: 4 months ]
    tape measure in centimeters

  13. Waist line [ Time Frame: 12 months ]
    tape measure in centimeters

  14. Waist line [ Time Frame: 18 months ]
    tape measure in centimeters

  15. Physical Activity Questionnaire [ Time Frame: 4 months ]
    HUNT 1 physical activity questionnaire

  16. Physical Activity Questionnaire [ Time Frame: 12 months ]
    HUNT 1 physical activity questionnaire

  17. Physical Activity Questionnaire [ Time Frame: 18 months ]
    HUNT 1 physical activity questionnaire

  18. Quality of life [ Time Frame: 4 months ]
    Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin

  19. Quality of life [ Time Frame: 12 months ]
    Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin

  20. Quality of life [ Time Frame: 18 months ]
    Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin

  21. Symptoms of anxiety and depression [ Time Frame: 4 months ]
    Hospital Anxiety and Depression Scale; Zigmond & Snaith

  22. Symptoms of anxiety and depression [ Time Frame: 12 months ]
    Hospital Anxiety and Depression Scale; Zigmond & Snaith

  23. Symptoms of anxiety and depression [ Time Frame: 18 months ]
    Hospital Anxiety and Depression Scale; Zigmond & Snaith

  24. Glucose concentration in blood [ Time Frame: 4 months ]
  25. Glucose concentration in blood [ Time Frame: 12 months ]
  26. Glucose concentration in blood [ Time Frame: 18 months ]
  27. Glycosylated haemoglobin (HbA1c) concentration in blood [ Time Frame: 4 months ]
  28. Glycosylated haemoglobin (HbA1c) concentration in blood [ Time Frame: 12 months ]
  29. Glycosylated haemoglobin (HbA1c) concentration in blood [ Time Frame: 18 months ]
  30. LDL concentration in blood [ Time Frame: 4 months ]
    Low Density Cholesterol

  31. LDL concentration in blood [ Time Frame: 12 months ]
    Low Density Cholesterol

  32. LDL concentration in blood [ Time Frame: 18 months ]
    Low Density Cholesterol

  33. HDL concentration in blood [ Time Frame: 4 months ]
    High Density Cholesterol

  34. HDL concentration in blood [ Time Frame: 12 months ]
    High Density Cholesterol

  35. HDL concentration in blood [ Time Frame: 18 months ]
    High Density Cholesterol

  36. Concentration of total cholesterol in blood [ Time Frame: 4 months ]
  37. Concentration of total cholesterol in blood [ Time Frame: 12 months ]
  38. Concentration of total cholesterol in blood [ Time Frame: 18 months ]
  39. Concentration of triglycerides in blood serum [ Time Frame: 4 months ]
  40. Concentration of triglycerides in blood serum [ Time Frame: 12 months ]
  41. Concentration of triglycerides in blood serum [ Time Frame: 18 months ]
  42. Concentration of HS-CRP in blood serum [ Time Frame: 4 months ]
    High Sensitive C-reactive protein

  43. Concentration of HS-CRP in blood serum [ Time Frame: 12 months ]
    High Sensitive C-reactive protein

  44. Concentration of HS-CRP in blood serum [ Time Frame: 18 months ]
    High Sensitive C-reactive protein

  45. C-peptide concentration in blood [ Time Frame: 4 months ]
  46. C-peptide concentration in blood [ Time Frame: 12 months ]
  47. C-peptide concentration in blood [ Time Frame: 18 months ]
  48. Leukocyte concentration in blood [ Time Frame: 4 months ]
  49. Leukocyte concentration in blood [ Time Frame: 12 months ]
  50. Leukocyte concentration in blood [ Time Frame: 18 months ]
  51. Potassium (K) concentration in blood [ Time Frame: 4 months ]
  52. Potassium (K) concentration in blood [ Time Frame: 12 months ]
  53. Potassium (K) concentration in blood [ Time Frame: 18 months ]
  54. Sodium (Na) concentration in blood [ Time Frame: 4 months ]
  55. Sodium (Na) concentration in blood [ Time Frame: 12 months ]
  56. Sodium (Na) concentration in blood [ Time Frame: 18 months ]
  57. Creatinine concentration in blood [ Time Frame: 4 months ]
  58. Creatinine concentration in blood [ Time Frame: 12 months ]
  59. Creatinine concentration in blood [ Time Frame: 18 months ]
  60. Apo-A concentration in blood serum [ Time Frame: 4 months ]
    Apolipoprotein A

  61. Apo-A concentration in blood serum [ Time Frame: 12 months ]
    Apolipoprotein A

  62. Apo-A concentration in blood serum [ Time Frame: 18 months ]
    Apolipoprotein A

  63. Apo-B concentration in blood serum [ Time Frame: 4 months ]
    Apolipoprotein B

  64. Apo-B concentration in blood serum [ Time Frame: 12 months ]
    Apolipoprotein B

  65. Apo-B concentration in blood serum [ Time Frame: 18 months ]
    Apolipoprotein B

  66. NT-ProBNP concentration in plasma [ Time Frame: 4 months ]
    N-Terminal Brain Natriuretic Peptide

  67. NT-ProBNP concentration in plasma [ Time Frame: 12 months ]
    N-Terminal Brain Natriuretic Peptide

  68. NT-ProBNP concentration in plasma [ Time Frame: 18 months ]
    N-Terminal Brain Natriuretic Peptide

  69. Lp(a) concentration in blood serum [ Time Frame: 4 months ]
    Lipoprotein(a)

  70. Lp(a) concentration in blood serum [ Time Frame: 12 months ]
    Lipoprotein(a)

  71. Lp(a) concentration in blood serum [ Time Frame: 18 months ]
    Lipoprotein(a)


Other Outcome Measures:
  1. Feasibility [ Time Frame: 4 months ]
    measured as attrition rate, Activity sensor errors

  2. Feasibility [ Time Frame: 12 months ]
    measured as attrition, Activity sensor errors,

  3. Feasibility [ Time Frame: 18 months ]
    measured as attrition, Activity sensor errors,

  4. Compliance [ Time Frame: 4 months ]
    actual use of Activity sensors; obtaining 80 % or more of prescribed physical Activity in home periods

  5. Compliance [ Time Frame: 12 months ]
    actual use of Activity sensors; obtaining 80 % or more of prescribed physical Activity in home periods

  6. Compliance [ Time Frame: 18 months ]
    actual use of Activity sensors; obtaining 80 % or more of prescribed physical Activity in home periods

  7. Meal frequency, compliance With a healthier lifestyle [ Time Frame: 4 months ]
    HUNT 3 questionnaire

  8. Meal frequency, compliance With a healthier lifestyle [ Time Frame: 12 months ]
    HUNT 3 questionnaire

  9. Meal frequency, compliance With a healthier lifestyle [ Time Frame: 18 months ]
    HUNT 3 questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826122


Locations
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Norway
LHL-Klinikkene
Røros, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
LHL Helse
Investigators
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Principal Investigator: Line Oldervoll, PhD LHL klinikkene / NTNU
More Information
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02826122    
Other Study ID Numbers: 2016/833
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight