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Lifestyle vs.Surgery for Morbid Obesity Treatment

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Phase 3
Locations
Greece
Study Type
Interventional
Intervention
Lifestyle counselling
Bariatric Surgery
Sponsored by
Harokopio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Lifestyle intervention, Bariatric surgery, Weight management, Physical activity

Eligibility Criteria

21 Years - 51 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Harokopio University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bariatric Surgery

Lifestyle counselling

Arm Description

Outcomes

Primary Outcome Measures

The weight lost (kg) and maintained (kg) following each intervention (bariatric surgery and behavioural modification)

Secondary Outcome Measures

Physical Activity Level post bariatric surgery and behavioural modification of morbid obese patients.
Resting Metabolic Rate (kcal/d) post bariatric surgery and behavioral modofication in morbid obese patients.
Fat mass (kg) and fat free mass (kg) post bariatric surgery and behavioural modification in morbid obese patients.
Changes in dietary intake and eating habits post bariatric surgery and behavioural modification.
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).

Full Information

First Posted
April 15, 2014
Last Updated
April 22, 2014
Sponsor
Harokopio University
Collaborators
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT02122029
Brief Title
Lifestyle vs.Surgery for Morbid Obesity Treatment
Official Title
A Nine-Year Follow-up of Intensive Lifestyle Intervention vs Surgery to Treat Morbidly Obese Women: a Non-randomized Human Subject Research.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harokopio University
Collaborators
The University of Texas Medical Branch, Galveston

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Lifestyle intervention, Bariatric surgery, Weight management, Physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bariatric Surgery
Arm Type
Experimental
Arm Title
Lifestyle counselling
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counselling
Intervention Description
Behavioral techniques for weight management
Intervention Type
Procedure
Intervention Name(s)
Bariatric Surgery
Intervention Description
Vertical Banding Gastroplasty
Primary Outcome Measure Information:
Title
The weight lost (kg) and maintained (kg) following each intervention (bariatric surgery and behavioural modification)
Time Frame
9 years
Secondary Outcome Measure Information:
Title
Physical Activity Level post bariatric surgery and behavioural modification of morbid obese patients.
Time Frame
9 years
Title
Resting Metabolic Rate (kcal/d) post bariatric surgery and behavioral modofication in morbid obese patients.
Time Frame
3 years
Title
Fat mass (kg) and fat free mass (kg) post bariatric surgery and behavioural modification in morbid obese patients.
Time Frame
3 years
Title
Changes in dietary intake and eating habits post bariatric surgery and behavioural modification.
Description
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).
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Labros S Sidossis, Professor
Organizational Affiliation
Department of Internal Medicine, Surgery, and Nutrition and Metabolism, University of Texas Medical Branch at Galveston, Texas, USA
Official's Role
Study Director
Facility Information:
Facility Name
Harokopio University
City
Athens
ZIP/Postal Code
17671
Country
Greece

12. IPD Sharing Statement

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Lifestyle vs.Surgery for Morbid Obesity Treatment

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