Suboptimal Weight Loss After Gastric Bypass Surgery

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01829906
• Other study ID #: 321
• Status: Terminated
• Phase: N/A
• First received: April 9, 2013
• Last updated: October 2, 2017
• Start date: August 2013
• Est. completion date: August 2014

Study information

• Verified date: September 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid
• Weight Loss

Intervention

Behavioral:
• Multidisciplinary outpatient programme

• Inpatient lifestyle programme

Locations

Country	Name	City	State
Norway	St. Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Amundsen T, Strømmen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss change	Changes in body weight will be assessed at the end of the intervention (1 year)	from baseline to 1 year
Secondary	Risk factors	Risk factors: fasting plasma glucose and lipids (triglycerides, total cholesterol, HDL cholesterol) and blood pressure will be assessed	One year