Lifestyle vs.Surgery for Morbid Obesity Treatment

NCT ID: NCT02122029

Last Updated: 2014-04-24

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

PHASE3

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2013-10-31

Brief Summary

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The purpose of the current study is to determine whether an intensive lifestyle intervention was as effective as surgery to treat morbid obesity nine years post-intervention.

Detailed Description

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Behavioral/lifestyle interventions produce acceptable success in treating moderately obese subjects. However, their effectiveness on weight loss and maintenance in morbidly obese subjects remains elusive.

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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Morbid Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bariatric Surgery

Group Type EXPERIMENTAL

Lifestyle counselling

Intervention Type BEHAVIORAL

Behavioral techniques for weight management

Lifestyle counselling

Group Type EXPERIMENTAL

Bariatric Surgery

Intervention Type PROCEDURE

Vertical Banding Gastroplasty

Interventions

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Lifestyle counselling

Behavioral techniques for weight management

Intervention Type BEHAVIORAL

Bariatric Surgery

Vertical Banding Gastroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* female sex
* Age ≥ 18 years
* BMI ≥ 40 kg/m2
* Absence of mental illness as determined by evaluation by an experienced psychiatrist
Minimum Eligible Age

21 Years

Maximum Eligible Age

51 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role collaborator

Harokopio University

OTHER

Sponsor Role lead

Responsible Party

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M. Yannakoulia

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Greece

Other Identifiers

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LVS

Identifier Type: -

Identifier Source: org_study_id

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