Diastolic Dysfunction During Conservative Lifestyle Treatment

NCT ID: NCT02826122

Last Updated: 2018-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-08-31

Brief Summary

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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

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Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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FitBit APP

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

Group Type ACTIVE_COMPARATOR

FitBit APP

Intervention Type DEVICE

Prescription: Target daily 10.000 steps

Pai APP

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

Group Type EXPERIMENTAL

Pai APP

Intervention Type DEVICE

Prescription: Target 100 PAI Points per week

Interventions

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Pai APP

Prescription: Target 100 PAI Points per week

Intervention Type DEVICE

FitBit APP

Prescription: Target daily 10.000 steps

Intervention Type DEVICE

Other Intervention Names

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Personal Activity Intelligence (PAI) application MIO Fuse Wristband FitBit Zip

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LHL Helse

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Line Oldervoll, PhD

Role: PRINCIPAL_INVESTIGATOR

LHL klinikkene / NTNU

Locations

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LHL-Klinikkene

Røros, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 36404730 (View on PubMed)

Other Identifiers

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2016/833

Identifier Type: -

Identifier Source: org_study_id

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