Suboptimal Weight Loss After Gastric Bypass Surgery

Not Applicable

Terminated

• Conditions: Obesity, Morbid
• Interventions: Behavioral: Multidisciplinary outpatient programme; Behavioral: Inpatient lifestyle programme

• Registration Number: NCT01829906
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-09
• Study First Posted: 2013-04-11
• Study Start: 2013-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2017-09
• Last Update Submitted: 2017-10-02
• Last Update Posted: 2017-10-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Outpatient group	Multidisciplinary outpatient programme	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.
Inpatient group	Inpatient lifestyle programme	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.

Primary Outcome Measures

Name	Time	Method
Weight loss change	from baseline to 1 year	Changes in body weight will be assessed at the end of the intervention (1 year)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St. Olavs Hospital; 🇳🇴 Trondheim, Norway