Lifestyle vs.Surgery for Morbid Obesity Treatment

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122029
• Other study ID #: LVS
• Status: Completed
• Phase: Phase 3
• First received: April 15, 2014
• Last updated: April 22, 2014
• Start date: February 2003
• Est. completion date: October 2013

Study information

• Verified date: April 2014
• Source: Harokopio University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Evangelismos Hospital
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 51 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Behavioral:
• Lifestyle counselling
Behavioral techniques for weight management

Procedure:
• Bariatric Surgery
Vertical Banding Gastroplasty

Locations

Country	Name	City	State
Greece	Harokopio University	Athens

Sponsors (2)

Lead Sponsor	Collaborator
Harokopio University	The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The weight lost (kg) and maintained (kg) following each intervention (bariatric surgery and behavioural modification)		9 years	Yes
Secondary	Physical Activity Level post bariatric surgery and behavioural modification of morbid obese patients.		9 years	Yes
Secondary	Resting Metabolic Rate (kcal/d) post bariatric surgery and behavioral modofication in morbid obese patients.		3 years	Yes
Secondary	Fat mass (kg) and fat free mass (kg) post bariatric surgery and behavioural modification in morbid obese patients.		3 years	Yes
Secondary	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).	3 years	Yes