Lifestyle vs.Surgery for Morbid Obesity Treatment

April 22, 2014 updated by: M. Yannakoulia, Harokopio University

A Nine-Year Follow-up of Intensive Lifestyle Intervention vs Surgery to Treat Morbidly Obese Women: a Non-randomized Human Subject Research.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 17671
        • Harokopio University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female sex
  • Age ≥ 18 years
  • BMI ≥ 40 kg/m2
  • Absence of mental illness as determined by evaluation by an experienced psychiatrist
  • Additional inclusion criteria for vertical banded gastroplasty were history of multiple, non-successful, previous attempts for weight loss

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bariatric Surgery
Behavioral: Lifestyle counselling
Behavioral techniques for weight management
Experimental: Lifestyle counselling
Procedure: Bariatric Surgery
Vertical Banding Gastroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The weight lost (kg) and maintained (kg) following each intervention (bariatric surgery and behavioural modification)
Time Frame: 9 years
9 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity Level post bariatric surgery and behavioural modification of morbid obese patients.
Time Frame: 9 years
9 years
Resting Metabolic Rate (kcal/d) post bariatric surgery and behavioral modofication in morbid obese patients.
Time Frame: 3 years
3 years
Fat mass (kg) and fat free mass (kg) post bariatric surgery and behavioural modification in morbid obese patients.
Time Frame: 3 years
3 years
Changes in dietary intake and eating habits post bariatric surgery and behavioural modification.
Time Frame: 3 years

Dietary intake measured as energy intake (kcal/d) derived from fat, protein and carbohydrate.

Eating habits were reflected by the reported consumption of fruits, vegetables, sweets (portions/d).
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harokopio University

Collaborators

The University of Texas Medical Branch, Galveston

Investigators

  • Study Director: Labros S Sidossis, Professor, Department of Internal Medicine, Surgery, and Nutrition and Metabolism, University of Texas Medical Branch at Galveston, Texas, USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

April 22, 2014

First Posted (Estimate)

April 24, 2014

Study Record Updates

Last Update Posted (Estimate)

April 24, 2014

Last Update Submitted That Met QC Criteria

April 22, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LVS

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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