Lifestyle vs.Surgery for Morbid Obesity Treatment

Study Overview
=================
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.

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

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Behavioral: Lifestyle counselling
* Procedure: Bariatric Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 51 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bariatric Surgery<br> | Behavioral: Lifestyle counselling<br>* Behavioral techniques for weight management<br>|
| Experimental: Lifestyle counselling<br> | Procedure: Bariatric Surgery<br>* Vertical Banding Gastroplasty<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The weight lost (kg) and maintained (kg) following each intervention (bariatric surgery and behavioural modification) |  | 9 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lifestyle intervention, Bariatric surgery, Weight management, Physical activity