Suboptimal Weight Loss After Gastric Bypass Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Norwegian University of Science and Technology
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01829906
First received: April 9, 2013
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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 Intervention
Obesity, Morbid
Behavioral: Multidisciplinary outpatient programme
Behavioral: Inpatient lifestyle programme

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Two Lifestyle Interventions for Suboptimal Weight Loss After Gastric Bypass Surgery

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Weight loss change [ Time Frame: from baseline to 1 year ] [ Designated as safety issue: No ]
    Changes in body weight will be assessed at the end of the intervention (1 year)


Secondary Outcome Measures:
  • Risk factors [ Time Frame: One year ] [ Designated as safety issue: No ]
    Risk factors: fasting plasma glucose and lipids (triglycerides, total cholesterol, HDL cholesterol) and blood pressure will be assessed


Estimated Enrollment: 60
Study Start Date: August 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01829906

Contacts
Contact: Catia Martins, PhD +4748603643 catia.martins@ntnu.no

Locations
Norway
St. Olavs Hospital Recruiting
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Study Director: Bård Kulseng, md phd Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01829906     History of Changes
Other Study ID Numbers: 321
Study First Received: April 9, 2013
Last Updated: June 6, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
weight loss
bariatric surgery
gastric bypass
health education
nutrition therapy
diet
exercise
cognitive therapy

Additional relevant MeSH terms:
Weight Loss
Obesity, Morbid
Body Weight Changes
Body Weight
Signs and Symptoms
Obesity
Overnutrition
Nutrition Disorders
Overweight

ClinicalTrials.gov processed this record on September 18, 2014