NCT01112228

Brief Summary

This study will assess various published staging tools to assess the health impacts of obesity on individuals. The aim is to identify benefits and drawbacks, and thus help Obesity Centres and GPs better assess obese individuals as well as better identify who benefits most from having weight loss treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

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

October 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
9.2 years until next milestone

Results Posted

Study results publicly available

October 27, 2020

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

1.8 years

First QC Date

April 26, 2010

Results QC Date

August 12, 2020

Last Update Submit

October 5, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in Obesity Scores After Weight Loss Treatment

    Changes were measured in the following clinical domains -Airway, Body Mass Index, Cardiovascular risk, Diabetes, Economic, Functional. Gonadal, Body Image. An improvement was considered when any 1 of these domains changes for the positive. Thus, if a patient had an improvement in cardiovascular risk the intervention was considered beneficial even if no other domains changed. Out measure is calculated as the count of participants achieving at least 1 improvement (Count)

    Minimum of 1 year follow-up

Secondary Outcomes (1)

  • Changes in Obesity Scores in Various Subgroups

    Minimum of 1 year follow-up

Study Arms (1)

Obese patients

Obese patients for Bariatric surgery

Procedure: Bariatric surgery

Interventions

Bariatric surgery: Gastric bypass, Sleeve gastrectomy, or Gastric banding

Obese patients

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with BMI \> 40 or \>35 and a obesity-related medical condition

You may qualify if:

  • Morbid obesity
  • At least 1 year follow-up after bariatric surgery

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial Weight Centre, Imperial College London

London, United Kingdom

Location

Related Publications (1)

  • Aasheim ET, Aylwin SJ, Radhakrishnan ST, Sood AS, Jovanovic A, Olbers T, le Roux CW. Assessment of obesity beyond body mass index to determine benefit of treatment. Clin Obes. 2011 Apr;1(2-3):77-84. doi: 10.1111/j.1758-8111.2011.00017.x. Epub 2011 Jul 5.

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Results Point of Contact

Title
Carel le Roux
Organization
Imperial College

Study Officials

  • Carek le Roux, MD PhD

    Imperial College London

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2010

First Posted

April 28, 2010

Study Start

October 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

October 27, 2020

Results First Posted

October 27, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations