NCT01829906

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

October 4, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

April 9, 2013

Last Update Submit

October 2, 2017

Conditions

Obesity, Morbid

Keywords

weight lossbariatric surgerygastric bypasshealth educationnutrition therapydietexercisecognitive therapy

Outcome Measures

Primary Outcomes (1)

  • Weight loss change

    Changes in body weight will be assessed at the end of the intervention (1 year)

    from baseline to 1 year

Secondary Outcomes (1)

  • Risk factors

    One year

Study Arms (2)

Outpatient group

EXPERIMENTAL

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

Inpatient group

EXPERIMENTAL

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

Interventions

Multidisciplinary outpatient programmeBEHAVIORAL
Outpatient group
Inpatient lifestyle programmeBEHAVIORAL
Inpatient group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

  • 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.

    PMID: 27914028BACKGROUND

MeSH Terms

Conditions

Obesity, MorbidWeight LossHealth EducationMotor Activity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Bård Kulseng, md phd

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2013

First Posted

April 11, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

October 4, 2017

Record last verified: 2017-09

Locations

NO(1)