NCT00239850

Brief Summary

The purpose of this study is to evaluate the effects of conservative treatments of obesity with surgery (gastric bypass).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

March 24, 2017

Status Verified

March 1, 2017

Enrollment Period

1.7 years

First QC Date

October 13, 2005

Last Update Submit

March 21, 2017

Conditions

Morbid Obesity

Keywords

obesitylifestyletreatmentComplicationsendocrine changesLipidsC18.654.726.500.495

Outcome Measures

Primary Outcomes (2)

  • weight reduction

  • quality of life

Secondary Outcomes (1)

  • reduction in obesity complications

Interventions

lifestyle changesBEHAVIORAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index (BMI) \> 40 or BMI \> 35 with complications

You may not qualify if:

  • Unstable atherosclerotic disease
  • Psychologically unstable
  • Unable to participate in the training program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs Hospital

Trondheim, 7011, Norway

Location

Related Publications (2)

  • Martins C, Strommen M, Stavne OA, Nossum R, Marvik R, Kulseng B. Bariatric surgery versus lifestyle interventions for morbid obesity--changes in body weight, risk factors and comorbidities at 1 year. Obes Surg. 2011 Jul;21(7):841-9. doi: 10.1007/s11695-010-0131-1.

    PMID: 20379796RESULT

  • Ovrebo B, Strommen M, Kulseng B, Martins C. Bariatric surgery versus lifestyle interventions for severe obesity: 5-year changes in body weight, risk factors and comorbidities. Clin Obes. 2017 Jun;7(3):183-190. doi: 10.1111/cob.12190. Epub 2017 Mar 20.

    PMID: 28320081RESULT

MeSH Terms

Conditions

Obesity, MorbidObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Baard Kulseng, PhD, MD

    St. Olavs Hospital, Trondheim

    PRINCIPAL INVESTIGATOR

  • Ronald Mårvik, PhD, MD

    St. Olavs Hospital, Trondheim

    PRINCIPAL INVESTIGATOR

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

October 13, 2005

First Posted

October 17, 2005

Study Start

August 1, 2005

Primary Completion

April 1, 2007

Study Completion

August 1, 2007

Last Updated

March 24, 2017

Record last verified: 2017-03

Locations

NO(1)