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Diastolic Dysfunction During Conservative Lifestyle Treatment

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Pai APP
FitBit APP
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LHL-Klinikkene

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

FitBit APP

Pai APP

Arm Description

FitBit Zip APP registers and give feed-back on number of steps per day, distance and calories burned.

Mio Pai APP registers duration and intensity of the Activity and give feed back as activity Points.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

diastolic function
echocardiac examination assessed by GE Healthcare Vivid E9, Horten, Norway
diastolic function
echocardiac examination assessed by GE Healthcare Vivid E9, Horten, Norway
Cardiorespiratory fitness
Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany
Cardiorespiratory fitness
Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany
Cardiorespiratory fitness
Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany
Body composition
Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea)
Body composition
Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea)
Body composition
Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea)
Body Mass Index
Weight derived by squared height
Body Mass Index
Weight derived by squared height
Body Mass Index
Weight derived by squared height
Waist line
tape measure in centimeters
Waist line
tape measure in centimeters
Waist line
tape measure in centimeters
Physical Activity Questionnaire
HUNT 1 physical activity questionnaire
Physical Activity Questionnaire
HUNT 1 physical activity questionnaire
Physical Activity Questionnaire
HUNT 1 physical activity questionnaire
Quality of life
Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin
Quality of life
Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin
Quality of life
Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin
Symptoms of anxiety and depression
Hospital Anxiety and Depression Scale; Zigmond & Snaith
Symptoms of anxiety and depression
Hospital Anxiety and Depression Scale; Zigmond & Snaith
Symptoms of anxiety and depression
Hospital Anxiety and Depression Scale; Zigmond & Snaith
Glucose concentration in blood
Glucose concentration in blood
Glucose concentration in blood
Glycosylated haemoglobin (HbA1c) concentration in blood
Glycosylated haemoglobin (HbA1c) concentration in blood
Glycosylated haemoglobin (HbA1c) concentration in blood
LDL concentration in blood
Low Density Cholesterol
LDL concentration in blood
Low Density Cholesterol
LDL concentration in blood
Low Density Cholesterol
HDL concentration in blood
High Density Cholesterol
HDL concentration in blood
High Density Cholesterol
HDL concentration in blood
High Density Cholesterol
Concentration of total cholesterol in blood
Concentration of total cholesterol in blood
Concentration of total cholesterol in blood
Concentration of triglycerides in blood serum
Concentration of triglycerides in blood serum
Concentration of triglycerides in blood serum
Concentration of HS-CRP in blood serum
High Sensitive C-reactive protein
Concentration of HS-CRP in blood serum
High Sensitive C-reactive protein
Concentration of HS-CRP in blood serum
High Sensitive C-reactive protein
C-peptide concentration in blood
C-peptide concentration in blood
C-peptide concentration in blood
Leukocyte concentration in blood
Leukocyte concentration in blood
Leukocyte concentration in blood
Potassium (K) concentration in blood
Potassium (K) concentration in blood
Potassium (K) concentration in blood
Sodium (Na) concentration in blood
Sodium (Na) concentration in blood
Sodium (Na) concentration in blood
Creatinine concentration in blood
Creatinine concentration in blood
Creatinine concentration in blood
Apo-A concentration in blood serum
Apolipoprotein A
Apo-A concentration in blood serum
Apolipoprotein A
Apo-A concentration in blood serum
Apolipoprotein A
Apo-B concentration in blood serum
Apolipoprotein B
Apo-B concentration in blood serum
Apolipoprotein B
Apo-B concentration in blood serum
Apolipoprotein B
NT-ProBNP concentration in plasma
N-Terminal Brain Natriuretic Peptide
NT-ProBNP concentration in plasma
N-Terminal Brain Natriuretic Peptide
NT-ProBNP concentration in plasma
N-Terminal Brain Natriuretic Peptide
Lp(a) concentration in blood serum
Lipoprotein(a)
Lp(a) concentration in blood serum
Lipoprotein(a)
Lp(a) concentration in blood serum
Lipoprotein(a)

Full Information

First Posted
July 5, 2016
Last Updated
August 23, 2018
Sponsor
Norwegian University of Science and Technology
Collaborators
LHL Helse
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1. Study Identification

Unique Protocol Identification Number
NCT02826122
Brief Title
Diastolic Dysfunction During Conservative Lifestyle Treatment
Official Title
Prevalence of Diastolic Dysfunction and Effects of Conservative Lifestyle Treatment in Patients With Morbid Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
LHL Helse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FitBit APP
Arm Type
Active Comparator
Arm Description
FitBit Zip APP registers and give feed-back on number of steps per day, distance and calories burned.
Arm Title
Pai APP
Arm Type
Experimental
Arm Description
Mio Pai APP registers duration and intensity of the Activity and give feed back as activity Points.
Intervention Type
Device
Intervention Name(s)
Pai APP
Other Intervention Name(s)
Personal Activity Intelligence (PAI) application, MIO Fuse Wristband
Intervention Description
Prescription: Target 100 PAI Points per week
Intervention Type
Device
Intervention Name(s)
FitBit APP
Other Intervention Name(s)
FitBit Zip
Intervention Description
Prescription: Target daily 10.000 steps
Primary Outcome Measure Information:
Title
diastolic dysfunction
Description
echocardiac examination at baseline assessed by GE Healthcare Vivid E9, Horten, Norway
Time Frame
18 months
Secondary Outcome Measure Information:
Title
diastolic function
Description
echocardiac examination assessed by GE Healthcare Vivid E9, Horten, Norway
Time Frame
4 months
Title
diastolic function
Description
echocardiac examination assessed by GE Healthcare Vivid E9, Horten, Norway
Time Frame
12 months
Title
Cardiorespiratory fitness
Description
Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany
Time Frame
4 months
Title
Cardiorespiratory fitness
Description
Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany
Time Frame
12 months
Title
Cardiorespiratory fitness
Description
Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany
Time Frame
18 months
Title
Body composition
Description
Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea)
Time Frame
4 months
Title
Body composition
Description
Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea)
Time Frame
12 months
Title
Body composition
Description
Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea)
Time Frame
18 months
Title
Body Mass Index
Description
Weight derived by squared height
Time Frame
4 months
Title
Body Mass Index
Description
Weight derived by squared height
Time Frame
12 months
Title
Body Mass Index
Description
Weight derived by squared height
Time Frame
18 months
Title
Waist line
Description
tape measure in centimeters
Time Frame
4 months
Title
Waist line
Description
tape measure in centimeters
Time Frame
12 months
Title
Waist line
Description
tape measure in centimeters
Time Frame
18 months
Title
Physical Activity Questionnaire
Description
HUNT 1 physical activity questionnaire
Time Frame
4 months
Title
Physical Activity Questionnaire
Description
HUNT 1 physical activity questionnaire
Time Frame
12 months
Title
Physical Activity Questionnaire
Description
HUNT 1 physical activity questionnaire
Time Frame
18 months
Title
Quality of life
Description
Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin
Time Frame
4 months
Title
Quality of life
Description
Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin
Time Frame
12 months
Title
Quality of life
Description
Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin
Time Frame
18 months
Title
Symptoms of anxiety and depression
Description
Hospital Anxiety and Depression Scale; Zigmond & Snaith
Time Frame
4 months
Title
Symptoms of anxiety and depression
Description
Hospital Anxiety and Depression Scale; Zigmond & Snaith
Time Frame
12 months
Title
Symptoms of anxiety and depression
Description
Hospital Anxiety and Depression Scale; Zigmond & Snaith
Time Frame
18 months
Title
Glucose concentration in blood
Time Frame
4 months
Title
Glucose concentration in blood
Time Frame
12 months
Title
Glucose concentration in blood
Time Frame
18 months
Title
Glycosylated haemoglobin (HbA1c) concentration in blood
Time Frame
4 months
Title
Glycosylated haemoglobin (HbA1c) concentration in blood
Time Frame
12 months
Title
Glycosylated haemoglobin (HbA1c) concentration in blood
Time Frame
18 months
Title
LDL concentration in blood
Description
Low Density Cholesterol
Time Frame
4 months
Title
LDL concentration in blood
Description
Low Density Cholesterol
Time Frame
12 months
Title
LDL concentration in blood
Description
Low Density Cholesterol
Time Frame
18 months
Title
HDL concentration in blood
Description
High Density Cholesterol
Time Frame
4 months
Title
HDL concentration in blood
Description
High Density Cholesterol
Time Frame
12 months
Title
HDL concentration in blood
Description
High Density Cholesterol
Time Frame
18 months
Title
Concentration of total cholesterol in blood
Time Frame
4 months
Title
Concentration of total cholesterol in blood
Time Frame
12 months
Title
Concentration of total cholesterol in blood
Time Frame
18 months
Title
Concentration of triglycerides in blood serum
Time Frame
4 months
Title
Concentration of triglycerides in blood serum
Time Frame
12 months
Title
Concentration of triglycerides in blood serum
Time Frame
18 months
Title
Concentration of HS-CRP in blood serum
Description
High Sensitive C-reactive protein
Time Frame
4 months
Title
Concentration of HS-CRP in blood serum
Description
High Sensitive C-reactive protein
Time Frame
12 months
Title
Concentration of HS-CRP in blood serum
Description
High Sensitive C-reactive protein
Time Frame
18 months
Title
C-peptide concentration in blood
Time Frame
4 months
Title
C-peptide concentration in blood
Time Frame
12 months
Title
C-peptide concentration in blood
Time Frame
18 months
Title
Leukocyte concentration in blood
Time Frame
4 months
Title
Leukocyte concentration in blood
Time Frame
12 months
Title
Leukocyte concentration in blood
Time Frame
18 months
Title
Potassium (K) concentration in blood
Time Frame
4 months
Title
Potassium (K) concentration in blood
Time Frame
12 months
Title
Potassium (K) concentration in blood
Time Frame
18 months
Title
Sodium (Na) concentration in blood
Time Frame
4 months
Title
Sodium (Na) concentration in blood
Time Frame
12 months
Title
Sodium (Na) concentration in blood
Time Frame
18 months
Title
Creatinine concentration in blood
Time Frame
4 months
Title
Creatinine concentration in blood
Time Frame
12 months
Title
Creatinine concentration in blood
Time Frame
18 months
Title
Apo-A concentration in blood serum
Description
Apolipoprotein A
Time Frame
4 months
Title
Apo-A concentration in blood serum
Description
Apolipoprotein A
Time Frame
12 months
Title
Apo-A concentration in blood serum
Description
Apolipoprotein A
Time Frame
18 months
Title
Apo-B concentration in blood serum
Description
Apolipoprotein B
Time Frame
4 months
Title
Apo-B concentration in blood serum
Description
Apolipoprotein B
Time Frame
12 months
Title
Apo-B concentration in blood serum
Description
Apolipoprotein B
Time Frame
18 months
Title
NT-ProBNP concentration in plasma
Description
N-Terminal Brain Natriuretic Peptide
Time Frame
4 months
Title
NT-ProBNP concentration in plasma
Description
N-Terminal Brain Natriuretic Peptide
Time Frame
12 months
Title
NT-ProBNP concentration in plasma
Description
N-Terminal Brain Natriuretic Peptide
Time Frame
18 months
Title
Lp(a) concentration in blood serum
Description
Lipoprotein(a)
Time Frame
4 months
Title
Lp(a) concentration in blood serum
Description
Lipoprotein(a)
Time Frame
12 months
Title
Lp(a) concentration in blood serum
Description
Lipoprotein(a)
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
Feasibility
Description
measured as attrition rate, Activity sensor errors
Time Frame
4 months
Title
Feasibility
Description
measured as attrition, Activity sensor errors,
Time Frame
12 months
Title
Feasibility
Description
measured as attrition, Activity sensor errors,
Time Frame
18 months
Title
Compliance
Description
actual use of Activity sensors; obtaining 80 % or more of prescribed physical Activity in home periods
Time Frame
4 months
Title
Compliance
Description
actual use of Activity sensors; obtaining 80 % or more of prescribed physical Activity in home periods
Time Frame
12 months
Title
Compliance
Description
actual use of Activity sensors; obtaining 80 % or more of prescribed physical Activity in home periods
Time Frame
18 months
Title
Meal frequency, compliance With a healthier lifestyle
Description
HUNT 3 questionnaire
Time Frame
4 months
Title
Meal frequency, compliance With a healthier lifestyle
Description
HUNT 3 questionnaire
Time Frame
12 months
Title
Meal frequency, compliance With a healthier lifestyle
Description
HUNT 3 questionnaire
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Line Oldervoll, PhD
Organizational Affiliation
LHL klinikkene / NTNU
Official's Role
Principal Investigator
Facility Information:
Facility Name
LHL-Klinikkene
City
Røros
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Diastolic Dysfunction During Conservative Lifestyle Treatment

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