- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03593798
Lifestyle Intervention and Physical Capacity in Patients With Morbid Obesity (LEICO)
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bø, Norway, 3800
- Telemark University College
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Tønsberg, Norway, 3103
- Vestfold Hospital trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight change at 1-year follow up
Time Frame: Changes from baseline body weight at 1-year follow up.
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Can physical capacity before start of a routine medical care have a impact on weight loss at 1-year follow-up. Body weight was measured with patients wearing light clothing and no shoes on Scanvaegt DS-530 (Århus, Denmark) at baseline and after 1-year follow up. Changes from baseline body weight at 1-year follow up. Participants receive interventions as part of routine medical care, and studie the effect of the intervention. |
Changes from baseline body weight at 1-year follow up.
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Weight change at 12-weeks follow up
Time Frame: Changes from baseline body weight at 12-weeks follow up.
|
Can physical capacity before start of a routine medical care have a impact on weight loss at 12-weeks follow-up. Body weight was measured with patients wearing light clothing and no shoes on Scanvaegt DS-530 (Århus, Denmark) at baseline and after 12-weeks follow up. Changes from baseline body weight at 12-weeks follow up. Participants receive interventions as part of routine medical care, and studie the effect of the intervention. |
Changes from baseline body weight at 12-weeks follow up.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical capacity changes after 12 weeks as assessed by the maximal oxygen uptake test
Time Frame: Changes from baseline physical capacity at 12-weeks follow up.
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Can the mean twelve-week change in physical capacity be associated with weight loss. The maximal oxygen uptake test was performed as an incremental treadmill test on Woodway ELG 55 (Waukesha, Germany) or, for patients with walking restrictions, on an incremental bicycle test (Lode Corival V3, Lode BV, Groningen, Netherlands). Oxygen uptake was registered using the Jaeger oxycon pro ergospirometry test system (Jaeger Oxycon Pro JLAB 5.x, Hoechberg, Germany). Changes from baseline physical capacity at 12-weeks follow up. |
Changes from baseline physical capacity at 12-weeks follow up.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Jens Hertel, PhD, The Hospital of Vestfold
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LEICO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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