Back to resultsSuboptimal Weight Loss After Gastric Bypass Surgery
Primary Purpose
Obesity, Morbid
Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Multidisciplinary outpatient programme
Inpatient lifestyle programme
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Morbid focused on measuring weight loss, bariatric surgery, gastric bypass, health education, nutrition therapy, diet, exercise, cognitive therapy
Eligibility 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
Sites / Locations
- St. Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Outpatient group
Inpatient group
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Weight loss change
Changes in body weight will be assessed at the end of the intervention (1 year)
Secondary Outcome Measures
Risk factors
Risk factors: fasting plasma glucose and lipids (triglycerides, total cholesterol, HDL cholesterol) and blood pressure will be assessed
Full Information
NCT ID
NCT01829906
First Posted
April 9, 2013
Last Updated
October 2, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01829906
Brief Title
Suboptimal Weight Loss After Gastric Bypass Surgery
Official Title
Evaluation of the Efficacy of Two Lifestyle Interventions for Suboptimal Weight Loss After Gastric Bypass Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
too few candidates for enrollment
Study Start Date
August 2013 (Actual)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
weight loss, bariatric surgery, gastric bypass, health education, nutrition therapy, diet, exercise, cognitive therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Outpatient group
Arm Type
Experimental
Arm Description
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.
Arm Title
Inpatient group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multidisciplinary outpatient programme
Intervention Type
Behavioral
Intervention Name(s)
Inpatient lifestyle programme
Primary Outcome Measure Information:
Title
Weight loss change
Description
Changes in body weight will be assessed at the end of the intervention (1 year)
Time Frame
from baseline to 1 year
Secondary Outcome Measure Information:
Title
Risk factors
Description
Risk factors: fasting plasma glucose and lipids (triglycerides, total cholesterol, HDL cholesterol) and blood pressure will be assessed
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bård Kulseng, md phd
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
St. Olavs Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
27914028
Citation
Amundsen T, Strommen M, Martins C. Suboptimal Weight Loss and Weight Regain after Gastric Bypass Surgery-Postoperative Status of Energy Intake, Eating Behavior, Physical Activity, and Psychometrics. Obes Surg. 2017 May;27(5):1316-1323. doi: 10.1007/s11695-016-2475-7.
Results Reference
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Suboptimal Weight Loss After Gastric Bypass Surgery
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