Lifestyle Intervention and Physical Capacity in Patients With Morbid Obesity

NCT ID: NCT03593798

Last Updated: 2018-08-13

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

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-01

Study Completion Date

2016-05-30

Brief Summary

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Lifestyle intervention and physical capacity in patients with morbid Obesity (LEICO)

Detailed Description

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It is still uncertainty about which is the most effective lifestyle treatment to reducing body weight and increased quality of life. Increased physical capacity and muscle mass lead to increased energy expenditure, thus explaining parts of the difference in weight loss achieved after lifestyle treatment. However, literature in this area is limited and need better documentation of how, and to what extent increased physical capacity can affect the effect of lifestyle treatment offered to patients in the health service.

Conditions

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Physical Capacity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Lifestyle

Lifestyle intervention an effect on weight and physical capacity

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Treatment morbidly obese patients (BMI ≥ 40 kg/m2 or BMI 35 to 39.9 kg/m2 with ≥ 1 co morbidity) attending the Vestfold Hospital Trust.

Exclusion Criteria

* Uncompensated heart failure
* Recent myocardial infarction or stroke (\<½ years)
* Severe arrhythmia or heart failure
* Unstable angina pectoris
* Renal failure
* Severe eating disorders
* Active substance abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University college of south-east Norway

UNKNOWN

Sponsor Role collaborator

Sykehuset i Vestfold HF

OTHER

Sponsor Role lead

Responsible Party

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Jarle Berge

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jens Hertel, PhD

Role: STUDY_DIRECTOR

The Hospital of Vestfold

Locations

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Telemark University College

Bø, , Norway

Site Status

Vestfold Hospital Trust

Tønsberg, , Norway

Site Status

Countries

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Norway

References

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Berge J, Storen O, Hertel JK, Gjevestad E, Smastuen MC, Hjelmesaeth J. Associations between cardiorespiratory fitness and weight loss in patients with severe obesity undergoing an intensive lifestyle intervention program: retrospective cohort study. BMC Endocr Disord. 2019 Jul 1;19(1):69. doi: 10.1186/s12902-019-0394-z.

Reference Type DERIVED
PMID: 31262301 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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LEICO

Identifier Type: -

Identifier Source: org_study_id

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