Study on Impact of Lifestyle Change and Weight Loss Before Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of the trial is to determine whether a preoperative lifestyle intervention (targeting diet, exercise, and preparation for surgery) will favorably impact obesity-related parameters prior to bariatric surgery and improve short-term postoperative outcomes.

Detailed Description
-----------------
This is a randomized, controlled trial to evaluate the impact of a preoperative lifestyle intervention that targets diet, exercise, and preparation for surgery as an adjunct to the surgical treatment of obesity. Patients will be randomized to a 6-month lifestyle intervention (n = 100) or to usual care (n = 100) prior to undergoing bariatric surgery. We aim to evaluate the effect of the intervention on select pre- and postoperative outcomes. We hypothesize that patients who participate in the preoperative intervention will exhibit greater improvements in weight and related outcomes and better preparation for surgery than those who receive usual care. After operation, we hypothesize that patients who participate in the intervention will exhibit better compliance and fewer behavior-related eating problems, as well as a lower rate of complications and fewer outpatient visits with surgery-related conditions than those who received usual preoperative care. Our secondary aim is to determine whether the intervention affects weight/BMI trajectory through 24 months after operation.

Official Title
-----------------
Preoperative Lifestyle Intervention in Bariatric Surgery

Conditions
-----------------
Severe Obesity, Bariatric Surgery

Intervention / Treatment
-----------------
* Behavioral: Preoperative lifestyle Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any candidate for weight loss surgery who is at least 18 years old [At the University of Pittsburgh Medical Center, bariatric surgery is recommended as a treatment for individuals with Class III obesity (BMI > 40), or Class II obesity (BMI 35- 40) and serious obesity-related health problems] Exclusion Criteria: Mental retardation or psychosis Previously diagnosed genetic obesity syndrome Participation in a structured weight management program in the 6 months prior to study enrollment Uncontrolled psychiatric symptomatology sufficiently severe to require immediate treatment Pregnant or lactating in the previous 6 months Taking a medication known to affect body weight such as oral steroids in the previous 6 months Any previous surgery for weight loss Deemed high risk surgical candidate.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Usual preoperative care | |
| Experimental: 2<br>Preoperative Lifestyle Intervention | Behavioral: Preoperative lifestyle Intervention<br>* 6 month individual intervention consisting of weekly face-to-face and telephone sessions addressing diet, activity and preparation for surgery, followed by 3 booster telephone calls after surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight and related outcomes (BMI, cardiovascular risk, quality of life) |  | pre and post intervention | 
| preparation for surgery (eating, activity and knowledge of surgery) |  | pre and post intervention | 
| compliance and eating problems (vomiting, dumping, plugging etc.) |  | 6- and 12-months post surgery | 
| surgical complications and outpatient visits |  | 6- and 12-months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight/BMI trajectory |  | pre- and post-intervention; 6-, 12 and 24 months postop | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Morbid obesity, Diet therapy, Bariatric Surgery, Gastric bypass, Behavior therapy, Randomized controlled trial, Weight loss