Suboptimal Weight Loss After Gastric Bypass Surgery

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01829906

Enrollment

Registered

2013-04-11

Start date

2013-08-31

Completion date

2014-08-31

Last updated

2017-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Morbid

Keywords

weight loss, bariatric surgery, gastric bypass, health education, nutrition therapy, diet, exercise, cognitive therapy

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.

Interventions

BEHAVIORALMultidisciplinary outpatient programme

BEHAVIORALInpatient lifestyle programme

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Weight loss change	from baseline to 1 year	Changes in body weight will be assessed at the end of the intervention (1 year)

Secondary

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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026