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ObesityNCT02826122

Diastolic Dysfunction During Conservative Lifestyle Treatment

A study testing Pai APP and FitBit APP in people with Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Obesity
What is being tested?
Pai APP and FitBit APP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteNorway
Study dates
Aug 2016to Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • BMI > 40 kg/m2 (or BMI > 35 kg/m2 with comorbidity)
  • Stable weight last Three months (≤ 2 kg variation)
  • Norwegian speaking
  • Smartphone

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • LHL-Klinikkene

    Røros

Other trials in Norway

About this study

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

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

Conditions
Obesity
Being tested
Pai APP, FitBit APP
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pai APPDevice

    Also called Personal Activity Intelligence (PAI) application, MIO Fuse Wristband

    Prescription: Target 100 PAI Points per week

  • FitBit APPDevice

    Also called FitBit Zip

    Prescription: Target daily 10.000 steps

Study groups in NCT02826122
Study groupRoleWhat they receive
FitBit APPActive comparatorFitBit Zip APP registers and give feed-back on number of steps per day, distance and calories burned.
Receives: Device: FitBit APP
Pai APPExperimentalMio Pai APP registers duration and intensity of the Activity and give feed back as activity Points.
Receives: Device: Pai APP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. diastolic dysfunction

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

    Measured: 18 months

Secondary outcomes (71)

  1. diastolic function

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

    Measured: 4 months

  2. diastolic function

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

    Measured: 12 months

  3. Cardiorespiratory fitness

    Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany

    Measured: 4 months

  4. Cardiorespiratory fitness

    Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany

    Measured: 12 months

  5. Cardiorespiratory fitness

    Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany

    Measured: 18 months

  6. Body composition

    Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea)

    Measured: 4 months

  7. Body composition

    Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea)

    Measured: 12 months

  8. Body composition

    Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea)

    Measured: 18 months

  9. Body Mass Index

    Weight derived by squared height

    Measured: 4 months

  10. Body Mass Index

    Weight derived by squared height

    Measured: 12 months

  11. Body Mass Index

    Weight derived by squared height

    Measured: 18 months

  12. Waist line

    tape measure in centimeters

    Measured: 4 months

  13. Waist line

    tape measure in centimeters

    Measured: 12 months

  14. Waist line

    tape measure in centimeters

    Measured: 18 months

  15. Physical Activity Questionnaire

    HUNT 1 physical activity questionnaire

    Measured: 4 months

  16. Physical Activity Questionnaire

    HUNT 1 physical activity questionnaire

    Measured: 12 months

  17. Physical Activity Questionnaire

    HUNT 1 physical activity questionnaire

    Measured: 18 months

  18. Quality of life

    Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin

    Measured: 4 months

  19. Quality of life

    Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin

    Measured: 12 months

  20. Quality of life

    Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin

    Measured: 18 months

  21. Symptoms of anxiety and depression

    Hospital Anxiety and Depression Scale; Zigmond \& Snaith

    Measured: 4 months

  22. Symptoms of anxiety and depression

    Hospital Anxiety and Depression Scale; Zigmond \& Snaith

    Measured: 12 months

  23. Symptoms of anxiety and depression

    Hospital Anxiety and Depression Scale; Zigmond \& Snaith

    Measured: 18 months

  24. Glucose concentration in blood

    Measured: 4 months

  25. Glucose concentration in blood

    Measured: 12 months

  26. Glucose concentration in blood

    Measured: 18 months

  27. Glycosylated haemoglobin (HbA1c) concentration in blood

    Measured: 4 months

  28. Glycosylated haemoglobin (HbA1c) concentration in blood

    Measured: 12 months

  29. Glycosylated haemoglobin (HbA1c) concentration in blood

    Measured: 18 months

  30. LDL concentration in blood

    Low Density Cholesterol

    Measured: 4 months

  31. LDL concentration in blood

    Low Density Cholesterol

    Measured: 12 months

  32. LDL concentration in blood

    Low Density Cholesterol

    Measured: 18 months

  33. HDL concentration in blood

    High Density Cholesterol

    Measured: 4 months

  34. HDL concentration in blood

    High Density Cholesterol

    Measured: 12 months

  35. HDL concentration in blood

    High Density Cholesterol

    Measured: 18 months

  36. Concentration of total cholesterol in blood

    Measured: 4 months

  37. Concentration of total cholesterol in blood

    Measured: 12 months

  38. Concentration of total cholesterol in blood

    Measured: 18 months

  39. Concentration of triglycerides in blood serum

    Measured: 4 months

  40. Concentration of triglycerides in blood serum

    Measured: 12 months

  41. Concentration of triglycerides in blood serum

    Measured: 18 months

  42. Concentration of HS-CRP in blood serum

    High Sensitive C-reactive protein

    Measured: 4 months

  43. Concentration of HS-CRP in blood serum

    High Sensitive C-reactive protein

    Measured: 12 months

  44. Concentration of HS-CRP in blood serum

    High Sensitive C-reactive protein

    Measured: 18 months

  45. C-peptide concentration in blood

    Measured: 4 months

  46. C-peptide concentration in blood

    Measured: 12 months

  47. C-peptide concentration in blood

    Measured: 18 months

  48. Leukocyte concentration in blood

    Measured: 4 months

  49. Leukocyte concentration in blood

    Measured: 12 months

  50. Leukocyte concentration in blood

    Measured: 18 months

  51. Potassium (K) concentration in blood

    Measured: 4 months

  52. Potassium (K) concentration in blood

    Measured: 12 months

  53. Potassium (K) concentration in blood

    Measured: 18 months

  54. Sodium (Na) concentration in blood

    Measured: 4 months

  55. Sodium (Na) concentration in blood

    Measured: 12 months

  56. Sodium (Na) concentration in blood

    Measured: 18 months

  57. Creatinine concentration in blood

    Measured: 4 months

  58. Creatinine concentration in blood

    Measured: 12 months

  59. Creatinine concentration in blood

    Measured: 18 months

  60. Apo-A concentration in blood serum

    Apolipoprotein A

    Measured: 4 months

  61. Apo-A concentration in blood serum

    Apolipoprotein A

    Measured: 12 months

  62. Apo-A concentration in blood serum

    Apolipoprotein A

    Measured: 18 months

  63. Apo-B concentration in blood serum

    Apolipoprotein B

    Measured: 4 months

  64. Apo-B concentration in blood serum

    Apolipoprotein B

    Measured: 12 months

  65. Apo-B concentration in blood serum

    Apolipoprotein B

    Measured: 18 months

  66. NT-ProBNP concentration in plasma

    N-Terminal Brain Natriuretic Peptide

    Measured: 4 months

  67. NT-ProBNP concentration in plasma

    N-Terminal Brain Natriuretic Peptide

    Measured: 12 months

  68. NT-ProBNP concentration in plasma

    N-Terminal Brain Natriuretic Peptide

    Measured: 18 months

  69. Lp(a) concentration in blood serum

    Lipoprotein(a)

    Measured: 4 months

  70. Lp(a) concentration in blood serum

    Lipoprotein(a)

    Measured: 12 months

  71. Lp(a) concentration in blood serum

    Lipoprotein(a)

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionAug 2018
  4. Study completionAug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02826122
Sponsor's protocol ID
2016/833
Status last verified
Aug 2018
First submitted
5 Jul 2016
Last updated
27 Aug 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 36404730

Questions about this trial

What is this clinical trial studying?

A study testing Pai APP and FitBit APP in people with Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

diastolic dysfunction (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02826122, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.

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Clinical Trial NCT02826122 | AzTrials