The Effect of Lifestyle Treatment in Patients With Morbid Obesity

NCT ID: NCT03593148

Last Updated: 2021-09-01

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

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2025-12-23

Brief Summary

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The effect of lifestyle treatment on physical capacity, maximal strength, eating behavior and quality of life in patients with morbid obesity (LIFETIME)

Detailed Description

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In this study, the investigators will investigate whether more intensive day-based lifestyle treatment process have a better effect on weight loss and health-related quality of life than a previous treatment. Investigators also want to investigate whether patients with good physical capacity (maximal oxygen uptake) and bone strength (maximum bone strength) before initiating treatment and / or after 3 and 6 months intensive training may have greater weight loss 1 and 2 years after treatment than patients with lower physical capacity and bone strength.

Conditions

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Physical Capacity Leg Strength Eating Behavior Life of Quality

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lifestyle treatment

Patients will be included in the Lifestyle treatment that is a existing treatment program at Vestfold Hospital Trust.

Group Type OTHER

Lifestyle

Intervention Type OTHER

Lifestyle treatment

Interventions

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Lifestyle

Lifestyle treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Treatment seeking 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
* Pregnancy
* 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: PRINCIPAL_INVESTIGATOR

The Hospital of Vestfold

Locations

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Jarle Berge

Tønsberg, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Jarle Berge

Role: CONTACT

+47 33134111

Jens Hertel, PhD

Role: CONTACT

+4733342000

Facility Contacts

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Jarle Berge

Role: primary

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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LIFETIME

Identifier Type: -

Identifier Source: org_study_id

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