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Suboptimal Weight Loss After Gastric Bypass Surgery

NCT ID: NCT01829906

Last Updated: 2017-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity, Morbid

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Multidisciplinary outpatient programme

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Inpatient lifestyle programme

Intervention Type BEHAVIORAL

Interventions

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Multidisciplinary outpatient programme

Intervention Type BEHAVIORAL

Inpatient lifestyle programme

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bård Kulseng, md phd

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

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St. Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type BACKGROUND
PMID: 27914028 (View on PubMed)

Other Identifiers

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321

Identifier Type: -

Identifier Source: org_study_id