Suboptimal Weight Loss After Gastric Bypass Surgery

Norwegian University of Science and Technology49 enrolled

Overview

Bariatric surgery is the only long-term established treatment for morbid obesity. However, some patients experience suboptimal weight loss after surgery and/or experience a significant weight regain. Unfortunately there are very few studies in this area and little is known about the causes for lack of success or the best approach to treat this group of patients. The main aim of this study is to compare the efficacy of two different lifestyle treatment programs in this group of patients: 1) Hospital-based outpatient program or 2) an inpatient treatment program consisting of 3 - 3-week stays at a rehabilitation center over a 1-year period. Secondary aim is to determine potential reasons for suboptimal weight loss after bariatric surgery.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity, Morbid

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Body mass index (BMI) \>40kg/m2, or BMI\>35kg/m2 with comorbidities * healthy volunteers with suboptimal weight loss * health with significant weight regain after Roux-n-Y Gastric Bypass, defined as failure to lose at least 40% Excess Weight Loss by 12 months postoperatively. Significant weight regain: Regain of ≥15% of total weight lost after the first postoperative year. Exclusion Criteria: * Pregnancy * enrollment in another obesity treatment * previous revisional bariatric surgery * planned bariatric surgery * past or ongoing drug or alcohol abuse * physical or mental impairment that interferes with the ability to comply to treatment * history of severe psychological disorder * history of severe eating disorder * current medication known to affect appetite or induce weight loss

Outcomes

Primary Outcomes

Weight loss change

Changes in body weight will be assessed at the end of the intervention (1 year)

Time frame: from baseline to 1 year

Secondary Outcomes

Risk factors

Risk factors: fasting plasma glucose and lipids (triglycerides, total cholesterol, HDL cholesterol) and blood pressure will be assessed

Time frame: One year