Diastolic Dysfunction During Conservative Lifestyle Treatment

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Device: FitBit APP; Device: Pai APP

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Røros, Norway
    • LHL-Klinikkene

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diastolic dysfunction	echocardiac examination at baseline assessed by GE Healthcare Vivid E9, Horten, Norway	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diastolic function	echocardiac examination assessed by GE Healthcare Vivid E9, Horten, Norway	4 months
diastolic function	echocardiac examination assessed by GE Healthcare Vivid E9, Horten, Norway	12 months
Cardiorespiratory fitness	Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany	4 months
Cardiorespiratory fitness	Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany	12 months
Cardiorespiratory fitness	Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany	18 months
Body composition	Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea)	4 months
Body composition	Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea)	12 months
Body composition	Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea)	18 months
Body Mass Index	Weight derived by squared height	4 months
Body Mass Index	Weight derived by squared height	12 months
Body Mass Index	Weight derived by squared height	18 months
Waist line	tape measure in centimeters	4 months
Waist line	tape measure in centimeters	12 months
Waist line	tape measure in centimeters	18 months
Physical Activity Questionnaire	HUNT 1 physical activity questionnaire	4 months
Physical Activity Questionnaire	HUNT 1 physical activity questionnaire	12 months
Physical Activity Questionnaire	HUNT 1 physical activity questionnaire	18 months
Quality of life	Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin	4 months
Quality of life	Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin	12 months
Quality of life	Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin	18 months
Symptoms of anxiety and depression	Hospital Anxiety and Depression Scale; Zigmond & Snaith	4 months
Symptoms of anxiety and depression	Hospital Anxiety and Depression Scale; Zigmond & Snaith	12 months
Symptoms of anxiety and depression	Hospital Anxiety and Depression Scale; Zigmond & Snaith	18 months
Glucose concentration in blood		4 months
Glucose concentration in blood		12 months
Glucose concentration in blood		18 months
Glycosylated haemoglobin (HbA1c) concentration in blood		4 months
Glycosylated haemoglobin (HbA1c) concentration in blood		12 months
Glycosylated haemoglobin (HbA1c) concentration in blood		18 months
LDL concentration in blood	Low Density Cholesterol	4 months
LDL concentration in blood	Low Density Cholesterol	12 months
LDL concentration in blood	Low Density Cholesterol	18 months
HDL concentration in blood	High Density Cholesterol	4 months
HDL concentration in blood	High Density Cholesterol	12 months
HDL concentration in blood	High Density Cholesterol	18 months
Concentration of total cholesterol in blood		4 months
Concentration of total cholesterol in blood		12 months
Concentration of total cholesterol in blood		18 months
Concentration of triglycerides in blood serum		4 months
Concentration of triglycerides in blood serum		12 months
Concentration of triglycerides in blood serum		18 months
Concentration of HS-CRP in blood serum	High Sensitive C-reactive protein	4 months
Concentration of HS-CRP in blood serum	High Sensitive C-reactive protein	12 months
Concentration of HS-CRP in blood serum	High Sensitive C-reactive protein	18 months
C-peptide concentration in blood		4 months
C-peptide concentration in blood		12 months
C-peptide concentration in blood		18 months
Leukocyte concentration in blood		4 months
Leukocyte concentration in blood		12 months
Leukocyte concentration in blood		18 months
Potassium (K) concentration in blood		4 months
Potassium (K) concentration in blood		12 months
Potassium (K) concentration in blood		18 months
Sodium (Na) concentration in blood		4 months
Sodium (Na) concentration in blood		12 months
Sodium (Na) concentration in blood		18 months
Creatinine concentration in blood		4 months
Creatinine concentration in blood		12 months
Creatinine concentration in blood		18 months
Apo-A concentration in blood serum	Apolipoprotein A	4 months
Apo-A concentration in blood serum	Apolipoprotein A	12 months
Apo-A concentration in blood serum	Apolipoprotein A	18 months
Apo-B concentration in blood serum	Apolipoprotein B	4 months
Apo-B concentration in blood serum	Apolipoprotein B	12 months
Apo-B concentration in blood serum	Apolipoprotein B	18 months
NT-ProBNP concentration in plasma	N-Terminal Brain Natriuretic Peptide	4 months
NT-ProBNP concentration in plasma	N-Terminal Brain Natriuretic Peptide	12 months
NT-ProBNP concentration in plasma	N-Terminal Brain Natriuretic Peptide	18 months
Lp(a) concentration in blood serum	Lipoprotein(a)	4 months
Lp(a) concentration in blood serum	Lipoprotein(a)	12 months
Lp(a) concentration in blood serum	Lipoprotein(a)	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	measured as attrition rate, Activity sensor errors	4 months
Feasibility	measured as attrition, Activity sensor errors,	12 months
Feasibility	measured as attrition, Activity sensor errors,	18 months
Compliance	actual use of Activity sensors; obtaining 80 % or more of prescribed physical Activity in home periods	4 months
Compliance	actual use of Activity sensors; obtaining 80 % or more of prescribed physical Activity in home periods	12 months
Compliance	actual use of Activity sensors; obtaining 80 % or more of prescribed physical Activity in home periods	18 months
Meal frequency, compliance With a healthier lifestyle	HUNT 3 questionnaire	4 months
Meal frequency, compliance With a healthier lifestyle	HUNT 3 questionnaire	12 months
Meal frequency, compliance With a healthier lifestyle	HUNT 3 questionnaire	18 months

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: LHL Helse
• Investigators: Principal Investigator: Line Oldervoll, PhD, LHL klinikkene / NTNU

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (Estimate): July 7, 2016

Study Record Updates

• Last Update Posted (Actual): August 27, 2018
• Last Update Submitted That Met QC Criteria: August 23, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 2016/833

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED