NCT02122029

Lifestyle vs.Surgery for Morbid Obesity Treatment

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Harokopio University · Academic / Other
• Sex: Female
• Age: 21 Years – 51 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Morbid Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle counselling	Behavioral techniques for weight management
PROCEDURE	Bariatric Surgery	Vertical Banding Gastroplasty

Timeline

• Start date: 2003-02-01
• Primary completion: 2013-09-01
• Completion: 2013-10-01
• First posted: 2014-04-24
• Last updated: 2014-04-24

Locations

1 site across 1 country: Greece