Suboptimal Weight Loss After Gastric Bypass Surgery

October 2, 2017 updated by: Norwegian University of Science and Technology

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • St. Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
from baseline to 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

  • Study Director: Bård Kulseng, MD PhD, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

April 9, 2013

First Submitted That Met QC Criteria

April 9, 2013

First Posted (Estimate)

April 11, 2013

Study Record Updates

Last Update Posted (Actual)

October 4, 2017

Last Update Submitted That Met QC Criteria

October 2, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 321

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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