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Assessment of Outcomes Following Bariatric Surgery for Mississippi State Employees

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Katie McClendon, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01162668
First received: July 13, 2010
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  Purpose

Objective: to assess the health and economic outcomes (weight lost, change in control of chronic diseases such as diabetes, quality of life, work productivity, health care cost, etc) associated with bariatric (weight-loss) surgery for 200 severely obese patients who undergo bariatric surgery as part of the Mississippi State Employees' Life and Health Insurance Plan's Obesity Treatment Program (OTP).

2. Patient Characteristics: Inclusion criteria: Eligible bariatric surgical candidates who are enrolled in the OTP (100 patients per year for 2 years). The Plan's criteria includes, but is not limited to 1) enrollment in the plan for at least 12 consecutive months prior to September 1, 2009; 2) completion of the HealthQuotient health risk assessment through the Plan's wellness and health promotion program; 3) a Body Mass Index (BMI) of >40 kg/m2, or a BMI >35 kg/m2 with two or more co-morbidities such as diabetes, hypertension, sleep apnea or asthma; 4) two or more physician-supervised weight loss attempts within the last 24 months; 5) age 18 years or older; and 6) consent to provide personal and medical information to the Plan. Prior to surgery, each site administers a psychiatric evaluation to ensure the patient is psychologically stable for surgery. Exclusion criteria: any patient who does not meet criteria above or who declines to participate. Surgeries will take place only at Certified Bariatric Surgery Centers of Excellence (COE), of which, there are currently 3 in the state. The 3 COEs exist with 4 outpatient medical offices (1 COE is composed of 2 independent surgeon practices) Patients will be recruited at each site once they are approved by the OTP.

3. Design: prospective, observational, multi-center, longitudinal study of outcomes and resource utilization associated with OTP. Estimates of obesity and comorbidities' impact will be obtained from the outpatient medical office for the COEs. Medical charts, databases and medical/pharmacy claims will be the source of information. Surveys on quality of life, productivity, and patient satisfaction will be administered directly to patients. Database claim information will be obtained in future and is not a part of current IRB application.

4: Procedures: After obtaining informed consent, patients will be administered surveys at baseline, as well as at follow-up visits. Additional data will be obtained via patient charts, databases, and medical/pharmacy claims.


Condition
Bariatric Surgery
Obesity

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Assessment of Outcomes Following Bariatric Surgery for Mississippi State Employees

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Mississippi Medical Center:

Estimated Enrollment: 200
Study Start Date: April 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

200 obese patients with Mississippi State Employee Insurance who undergo bariatric surgery as part of Obesity Treatment Program

Criteria

Inclusion Criteria:

  • Eligible bariatric surgical candidates who are enrolled in the Mississippi SSELHI Plan (100 candidates enrolled per year). The Plan's criteria includes, but is not limited to

    1. enrollment in the plan for at least 12 consecutive months prior to September 1, 2009
    2. completion of the HealthQuotient health risk assessment through the Plan's wellness and health promotion program
    3. a Body Mass Index (BMI) of >40 kg/m2, or a BMI >35 kg/m2 with two or more co-morbidities such as diabetes, hypertension, sleep apnea or asthma
    4. two or more physician-supervised weight loss attempts within the last 24 months
    5. consent to provide personal and medical information to the Plan

Exclusion Criteria:

  • Any patient who does not meet criteria above or who declines to participate.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162668

Locations
United States, Mississippi
Central Mississippi Medical Center Comprehensive Weight Management Program
Jackson, Mississippi, United States, 39204
Oxford Surgical & Bariatric Clinic,LLC.
Oxford, Mississippi, United States, 38677
Oxford Bariatric
Oxford, Mississippi, United States, 28677
South Mississippi Surgical Weight Loss Center
Pascagoula, Mississippi, United States, 39567
Sponsors and Collaborators
University of Mississippi Medical Center
Allergan
Investigators
Principal Investigator: Katie S McClendon, Pharm.D. University of Mississippi Medical Center
  More Information

No publications provided

Responsible Party: Katie McClendon, Clinical Assistant Professor, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01162668     History of Changes
Other Study ID Numbers: 41165
Study First Received: July 13, 2010
Last Updated: May 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:
bariatric surgery
obesity
outcomes

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

ClinicalTrials.gov processed this record on May 21, 2013