Diastolic Dysfunction During Conservative Lifestyle Treatment

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Device: FitBit APP; Device: Pai APP

• Registration Number: NCT02826122
• Lead Sponsor: Norwegian University of Science and Technology

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-05
• Study First Posted: 2016-07-07
• Study Start: 2016-08
• Status Verified: 2018-08
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Last Update Submitted: 2018-08-23
• Last Update Posted: 2018-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FitBit APP	FitBit APP	FitBit Zip APP registers and give feed-back on number of steps per day, distance and calories burned.
Pai APP	Pai APP	Mio Pai APP registers duration and intensity of the Activity and give feed back as activity Points.

Primary Outcome Measures

Name	Time	Method
diastolic dysfunction	18 months	echocardiac examination at baseline assessed by GE Healthcare Vivid E9, Horten, Norway

Secondary Outcome Measures

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

Trial Locations

Locations (1)

LHL-Klinikkene; 🇳🇴 Røros, Norway