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Suboptimal Weight Loss After Gastric Bypass Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01829906
Recruitment Status : Terminated (too few candidates for enrollment)
First Posted : April 11, 2013
Last Update Posted : October 4, 2017
St. Olavs Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Behavioral: Multidisciplinary outpatient programme Behavioral: Inpatient lifestyle programme Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Two Lifestyle Interventions for Suboptimal Weight Loss After Gastric Bypass Surgery
Actual Study Start Date : August 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Outpatient group
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
Experimental: Inpatient group
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

Primary Outcome Measures :
  1. Weight loss change [ Time Frame: from baseline to 1 year ]
    Changes in body weight will be assessed at the end of the intervention (1 year)

Secondary Outcome Measures :
  1. Risk factors [ Time Frame: One year ]
    Risk factors: fasting plasma glucose and lipids (triglycerides, total cholesterol, HDL cholesterol) and blood pressure will be assessed

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01829906

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St. Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
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Study Director: Bård Kulseng, md phd Norwegian University of Science and Technology
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Responsible Party: Norwegian University of Science and Technology Identifier: NCT01829906    
Other Study ID Numbers: 321
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
weight loss
bariatric surgery
gastric bypass
health education
nutrition therapy
cognitive therapy
Additional relevant MeSH terms:
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Obesity, Morbid
Weight Loss
Body Weight Changes
Body Weight
Nutrition Disorders