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Completed

NCT Number: NCT02826122

Diastolic Dysfunction During Conservative Lifestyle Treatment

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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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LHL-Klinikkene

Røros, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pai APP

Device

Prescription: Target 100 PAI Points per week

Other names: Personal Activity Intelligence (PAI) application, MIO Fuse Wristband

FitBit APP

Device

Prescription: Target daily 10.000 steps

Other names: FitBit Zip

Primary outcomes

  1. diastolic dysfunction

    Time frame: 18 months

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

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • LHL Helse

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 7, 2016
Registry last updated
Aug 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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