Lifestyle vs.Surgery for Morbid Obesity Treatment

Phase 3CompletedNCT02122029

Harokopio University29 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Morbid Obesity

Interventions

Lifestyle counsellingBEHAVIORAL

Behavioral techniques for weight management

Bariatric SurgeryPROCEDURE

Vertical Banding Gastroplasty

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 51 Years

Medical Language ↔ Plain English

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

Locations (1)

Harokopio University

Athens, Greece

Outcomes

Primary Outcomes

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

Time frame: 9 years

Secondary Outcomes

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

Time frame: 9 years

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

Time frame: 3 years

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

Time frame: 3 years

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).

Time frame: 3 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.