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Clinical Staging Tools for the Impacts of Obesity on Individuals

Assessing Clinical Staging Tools for Tracking the Impacts of Obesity on Individuals

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01112228
Acronym
COST
Enrollment
600
Registered
2010-04-28
Start date
2009-10-31
Completion date
2011-08-31
Last updated
2020-10-27

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

Conditions

Morbid Obesity

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.

Detailed description

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

Interventions

PROCEDUREBariatric surgery

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

Sponsors

Imperial College London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* N/A

Design outcomes

Primary

MeasureTime frameDescription
Changes in Obesity Scores After Weight Loss TreatmentMinimum of 1 year follow-upChanges 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)

Secondary

MeasureTime frameDescription
Changes in Obesity Scores in Various SubgroupsMinimum of 1 year follow-upChanges in obesity scores in patients with carious co-morbid conditions (eg, type 2 diabetes, sleep apnoea) before bariatric surgery

Countries

United Kingdom

Participant flow

Participants by arm

ArmCount
Obese Patients
Obese patients for Bariatric surgery Bariatric surgery: Bariatric surgery: Gastric bypass, Sleeve gastrectomy, or Gastric banding
600
Total600

Baseline characteristics

CharacteristicObese Patients
Age, Customized
Age
48 years
STANDARD_DEVIATION 6
BMI (kg/m2 )49 kg/m^2
STANDARD_DEVIATION 12
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
600 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Sex: Female, Male
Female
420 Participants
Sex: Female, Male
Male
180 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 600
other
Total, other adverse events
30 / 600
serious
Total, serious adverse events
0 / 600

Outcome results

Primary

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)

Time frame: Minimum of 1 year follow-up

Population: Obese patients for Bariatric surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Obese PatientsChanges in Obesity Scores After Weight Loss Treatment600 Participants
Secondary

Changes in Obesity Scores in Various Subgroups

Changes in obesity scores in patients with carious co-morbid conditions (eg, type 2 diabetes, sleep apnoea) before bariatric surgery

Time frame: Minimum of 1 year follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Obese PatientsChanges in Obesity Scores in Various Subgroups130 Participants
Patients With Sleep ApneaChanges in Obesity Scores in Various Subgroups96 Participants

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026