Lifestyle vs.Surgery for Morbid Obesity Treatment

Phase 3

Completed

• Conditions: Morbid Obesity
• Interventions: Behavioral: Lifestyle counselling; Procedure: Bariatric Surgery

• Registration Number: NCT02122029
• Lead Sponsor: Harokopio University

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.

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2013-09
• Study Completion: 2013-10
• Status Verified: 2014-04
• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-22
• Last Update Submitted: 2014-04-22
• Study First Posted: 2014-04-24
• Last Update Posted: 2014-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bariatric Surgery	Lifestyle counselling	-
Lifestyle counselling	Bariatric Surgery	-

Primary Outcome Measures

Name	Time	Method
The weight lost (kg) and maintained (kg) following each intervention (bariatric surgery and behavioural modification)	9 years

Secondary Outcome Measures

Name	Time	Method
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	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).

Trial Locations

Locations (1)

Harokopio University; 🇬🇷 Athens, Greece