NCT02122029

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 24, 2014

Completed
Last Updated

April 24, 2014

Status Verified

April 1, 2014

Enrollment Period

10.6 years

First QC Date

April 15, 2014

Last Update Submit

April 22, 2014

Conditions

Morbid Obesity

Keywords

Lifestyle interventionBariatric surgeryWeight managementPhysical activity

Outcome Measures

Primary Outcomes (1)

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

    9 years

Secondary Outcomes (4)

  • Physical Activity Level post bariatric surgery and behavioural modification of morbid obese patients.

    9 years

  • Resting Metabolic Rate (kcal/d) post bariatric surgery and behavioral modofication in morbid obese patients.

    3 years

  • Fat mass (kg) and fat free mass (kg) post bariatric surgery and behavioural modification in morbid obese patients.

    3 years

  • Changes in dietary intake and eating habits post bariatric surgery and behavioural modification.

    3 years

Study Arms (2)

Bariatric Surgery

EXPERIMENTAL
Behavioral: Lifestyle counselling

Lifestyle counselling

EXPERIMENTAL
Procedure: Bariatric Surgery

Interventions

Lifestyle counsellingBEHAVIORAL

Behavioral techniques for weight management

Bariatric Surgery
Bariatric SurgeryPROCEDURE

Vertical Banding Gastroplasty

Lifestyle counselling

Eligibility Criteria

Age21 Years - 51 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harokopio University

Athens, 17671, Greece

Location

MeSH Terms

Conditions

Obesity, MorbidMotor Activity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Labros S Sidossis, Professor

    Department of Internal Medicine, Surgery, and Nutrition and Metabolism, University of Texas Medical Branch at Galveston, Texas, USA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 15, 2014

First Posted

April 24, 2014

Study Start

February 1, 2003

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

April 24, 2014

Record last verified: 2014-04

Locations

GR(1)