Suboptimal Weight Loss After Gastric Bypass Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Efficacy of Two Lifestyle Interventions for Suboptimal Weight Loss After Gastric Bypass Surgery

Conditions
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Obesity, Morbid

Intervention / Treatment
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* Behavioral: Multidisciplinary outpatient programme
* Behavioral: Inpatient lifestyle programme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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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: Outpatient group<br>Multidisciplinary outpatient programme including both individual and group-based therapy. During the first visit, every patient will have an individual consultation with the dietician, physiotherapist and psychiatric nurse. After this, the patients will be followed up in groups every month for the first four months and every two months afterwards up to one year. The intervention will focus on nutritional education, healthy eating, increased physical activity levels (aiming initially at 10 minutes/day, then increasing to 30 minutes/day) and cognitive therapy. | Behavioral: Multidisciplinary outpatient programme<br> <br> |
| Experimental: Inpatient group<br>Inpatient lifestyle programme offered at a rehabilitation center consisting of a continuous care weight loss program, with three intermittent stays (each with three-week duration) over a one year period. | Behavioral: Inpatient lifestyle programme<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss change | Changes in body weight will be assessed at the end of the intervention (1 year) | from baseline to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors | Risk factors: fasting plasma glucose and lipids (triglycerides, total cholesterol, HDL cholesterol) and blood pressure will be assessed | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss, bariatric surgery, gastric bypass, health education, nutrition therapy, diet, exercise, cognitive therapy