Study Results
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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COMPLETED
PHASE3
29 participants
INTERVENTIONAL
2003-02-28
2013-10-31
Brief Summary
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Detailed Description
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Twenty-nine morbidly obese females participated in this non-randomized study. Fifteen subjects were assigned to the lifestyle group and 14 underwent vertical banded gastroplasty. Subjects in the lifestyle group attended 30 behavioral modification sessions over three years, whereas the surgery group received the standard of care nutrition. Body weight, resting metabolic rate, physical activity, body composition measurements and dietary intake data were assessed at standard time points during the first 3 years post-intervention. Follow-up data on body weight and physical activity were also collected 9 years later.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bariatric Surgery
Lifestyle counselling
Behavioral techniques for weight management
Lifestyle counselling
Bariatric Surgery
Vertical Banding Gastroplasty
Interventions
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Lifestyle counselling
Behavioral techniques for weight management
Bariatric Surgery
Vertical Banding Gastroplasty
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* BMI ≥ 40 kg/m2
* Absence of mental illness as determined by evaluation by an experienced psychiatrist
21 Years
51 Years
FEMALE
No
Sponsors
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The University of Texas Medical Branch, Galveston
OTHER
Harokopio University
OTHER
Responsible Party
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M. Yannakoulia
Associate Professor
Principal Investigators
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Labros S Sidossis, Professor
Role: STUDY_DIRECTOR
Department of Internal Medicine, Surgery, and Nutrition and Metabolism, University of Texas Medical Branch at Galveston, Texas, USA
Locations
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Harokopio University
Athens, , Greece
Countries
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Other Identifiers
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LVS
Identifier Type: -
Identifier Source: org_study_id
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