Clinical Obesity Staging Tools (COST)

This study has been completed.
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT01112228
First received: April 26, 2010
Last updated: September 17, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Morbid Obesity
Procedure: Bariatric surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Clinical Staging Tools for Tracking the Impacts of Obesity on Individuals

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Changes in Obesity Scores after weight loss treatment [ Time Frame: Minimum of 1 year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in obesity scores in various subgroups [ Time Frame: Minimum of 1 year follow-up ] [ Designated as safety issue: No ]
    Changes in obesity scores in patients with carious co-morbid conditions (eg, type 2 diabetes, sleep apnoea) before bariatric surgery

  • Inter-rater variability [ Time Frame: Minimum of 1 year follow-up ] [ Designated as safety issue: No ]
    Variability in obesity scores assigned by various observers


Enrollment: 600
Study Start Date: October 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Obese patients Procedure: Bariatric surgery
Gastric bypass, Sleeve gastrectomy, or Gastric banding

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112228

Locations
United Kingdom
Imperial Weight Centre, Imperial College London
London, United Kingdom
Sponsors and Collaborators
Imperial College London
Investigators
Study Chair: Carek le Roux, MD PhD Imperial College London
  More Information

No publications provided

Responsible Party: Dr Carel le Roux, Imperial College London
ClinicalTrials.gov Identifier: NCT01112228     History of Changes
Other Study ID Numbers: Clinical Obesity Staging Tools
Study First Received: April 26, 2010
Last Updated: September 17, 2010
Health Authority: United Kingdom: Imperial College NHS Trust

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014