Diastolic Dysfunction During Conservative Lifestyle Treatment

August 23, 2018 updated by: Norwegian University of Science and Technology

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Røros, Norway
        • LHL-Klinikkene

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
diastolic dysfunction
Time Frame: 18 months
echocardiac examination at baseline assessed by GE Healthcare Vivid E9, Horten, Norway
18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
diastolic function
Time Frame: 4 months
echocardiac examination assessed by GE Healthcare Vivid E9, Horten, Norway
4 months
diastolic function
Time Frame: 12 months
echocardiac examination assessed by GE Healthcare Vivid E9, Horten, Norway
12 months
Cardiorespiratory fitness
Time Frame: 4 months
Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany
4 months
Cardiorespiratory fitness
Time Frame: 12 months
Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany
12 months
Cardiorespiratory fitness
Time Frame: 18 months
Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany
18 months
Body composition
Time Frame: 4 months
Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea)
4 months
Body composition
Time Frame: 12 months
Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea)
12 months
Body composition
Time Frame: 18 months
Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea)
18 months
Body Mass Index
Time Frame: 4 months
Weight derived by squared height
4 months
Body Mass Index
Time Frame: 12 months
Weight derived by squared height
12 months
Body Mass Index
Time Frame: 18 months
Weight derived by squared height
18 months
Waist line
Time Frame: 4 months
tape measure in centimeters
4 months
Waist line
Time Frame: 12 months
tape measure in centimeters
12 months
Waist line
Time Frame: 18 months
tape measure in centimeters
18 months
Physical Activity Questionnaire
Time Frame: 4 months
HUNT 1 physical activity questionnaire
4 months
Physical Activity Questionnaire
Time Frame: 12 months
HUNT 1 physical activity questionnaire
12 months
Physical Activity Questionnaire
Time Frame: 18 months
HUNT 1 physical activity questionnaire
18 months
Quality of life
Time Frame: 4 months
Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin
4 months
Quality of life
Time Frame: 12 months
Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin
12 months
Quality of life
Time Frame: 18 months
Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin
18 months
Symptoms of anxiety and depression
Time Frame: 4 months
Hospital Anxiety and Depression Scale; Zigmond & Snaith
4 months
Symptoms of anxiety and depression
Time Frame: 12 months
Hospital Anxiety and Depression Scale; Zigmond & Snaith
12 months
Symptoms of anxiety and depression
Time Frame: 18 months
Hospital Anxiety and Depression Scale; Zigmond & Snaith
18 months
Glucose concentration in blood
Time Frame: 4 months
4 months
Glucose concentration in blood
Time Frame: 12 months
12 months
Glucose concentration in blood
Time Frame: 18 months
18 months
Glycosylated haemoglobin (HbA1c) concentration in blood
Time Frame: 4 months
4 months
Glycosylated haemoglobin (HbA1c) concentration in blood
Time Frame: 12 months
12 months
Glycosylated haemoglobin (HbA1c) concentration in blood
Time Frame: 18 months
18 months
LDL concentration in blood
Time Frame: 4 months
Low Density Cholesterol
4 months
LDL concentration in blood
Time Frame: 12 months
Low Density Cholesterol
12 months
LDL concentration in blood
Time Frame: 18 months
Low Density Cholesterol
18 months
HDL concentration in blood
Time Frame: 4 months
High Density Cholesterol
4 months
HDL concentration in blood
Time Frame: 12 months
High Density Cholesterol
12 months
HDL concentration in blood
Time Frame: 18 months
High Density Cholesterol
18 months
Concentration of total cholesterol in blood
Time Frame: 4 months
4 months
Concentration of total cholesterol in blood
Time Frame: 12 months
12 months
Concentration of total cholesterol in blood
Time Frame: 18 months
18 months
Concentration of triglycerides in blood serum
Time Frame: 4 months
4 months
Concentration of triglycerides in blood serum
Time Frame: 12 months
12 months
Concentration of triglycerides in blood serum
Time Frame: 18 months
18 months
Concentration of HS-CRP in blood serum
Time Frame: 4 months
High Sensitive C-reactive protein
4 months
Concentration of HS-CRP in blood serum
Time Frame: 12 months
High Sensitive C-reactive protein
12 months
Concentration of HS-CRP in blood serum
Time Frame: 18 months
High Sensitive C-reactive protein
18 months
C-peptide concentration in blood
Time Frame: 4 months
4 months
C-peptide concentration in blood
Time Frame: 12 months
12 months
C-peptide concentration in blood
Time Frame: 18 months
18 months
Leukocyte concentration in blood
Time Frame: 4 months
4 months
Leukocyte concentration in blood
Time Frame: 12 months
12 months
Leukocyte concentration in blood
Time Frame: 18 months
18 months
Potassium (K) concentration in blood
Time Frame: 4 months
4 months
Potassium (K) concentration in blood
Time Frame: 12 months
12 months
Potassium (K) concentration in blood
Time Frame: 18 months
18 months
Sodium (Na) concentration in blood
Time Frame: 4 months
4 months
Sodium (Na) concentration in blood
Time Frame: 12 months
12 months
Sodium (Na) concentration in blood
Time Frame: 18 months
18 months
Creatinine concentration in blood
Time Frame: 4 months
4 months
Creatinine concentration in blood
Time Frame: 12 months
12 months
Creatinine concentration in blood
Time Frame: 18 months
18 months
Apo-A concentration in blood serum
Time Frame: 4 months
Apolipoprotein A
4 months
Apo-A concentration in blood serum
Time Frame: 12 months
Apolipoprotein A
12 months
Apo-A concentration in blood serum
Time Frame: 18 months
Apolipoprotein A
18 months
Apo-B concentration in blood serum
Time Frame: 4 months
Apolipoprotein B
4 months
Apo-B concentration in blood serum
Time Frame: 12 months
Apolipoprotein B
12 months
Apo-B concentration in blood serum
Time Frame: 18 months
Apolipoprotein B
18 months
NT-ProBNP concentration in plasma
Time Frame: 4 months
N-Terminal Brain Natriuretic Peptide
4 months
NT-ProBNP concentration in plasma
Time Frame: 12 months
N-Terminal Brain Natriuretic Peptide
12 months
NT-ProBNP concentration in plasma
Time Frame: 18 months
N-Terminal Brain Natriuretic Peptide
18 months
Lp(a) concentration in blood serum
Time Frame: 4 months
Lipoprotein(a)
4 months
Lp(a) concentration in blood serum
Time Frame: 12 months
Lipoprotein(a)
12 months
Lp(a) concentration in blood serum
Time Frame: 18 months
Lipoprotein(a)
18 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 4 months
measured as attrition rate, Activity sensor errors
4 months
Feasibility
Time Frame: 12 months
measured as attrition, Activity sensor errors,
12 months
Feasibility
Time Frame: 18 months
measured as attrition, Activity sensor errors,
18 months
Compliance
Time Frame: 4 months
actual use of Activity sensors; obtaining 80 % or more of prescribed physical Activity in home periods
4 months
Compliance
Time Frame: 12 months
actual use of Activity sensors; obtaining 80 % or more of prescribed physical Activity in home periods
12 months
Compliance
Time Frame: 18 months
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
Time Frame: 4 months
HUNT 3 questionnaire
4 months
Meal frequency, compliance With a healthier lifestyle
Time Frame: 12 months
HUNT 3 questionnaire
12 months
Meal frequency, compliance With a healthier lifestyle
Time Frame: 18 months
HUNT 3 questionnaire
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Norwegian University of Science and Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
LHL Helse

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Line Oldervoll, PhD, LHL klinikkene / NTNU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016/833

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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