Assessment of Outcomes Following Bariatric Surgery for Mississippi State Employees

NCT01162668 | Completed

• 1 other identifier: 41165
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Obesity

Keywords

bariatric surgery; obesity; outcomes

Outcome Measures

Primary Outcomes (2)

• Weight loss

  change in weight from baseline

  0, 6, 12, and 24 months

• Body mass index (BMI)

  Change in body mass index (BMI) from baseline

  0, 6, 12, and 24 months

Secondary Outcomes (6)

• ecomonic outcomes

  0, 6, 12, and 24 months

• Systolic blood pressure

  0, 6, 12, and 24 months

• Diastolic blood pressure

  0, 6, 12, and 24 months

• Medication use

  0, 6, 12, and 24 months

• quality of life

  0, 6, 12, and 24 months

Other Outcomes (1)

• Surgery-related adverse events

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• enrollment in the plan for at least 12 consecutive months prior to September 1, 2009
• completion of the HealthQuotient health risk assessment through the Plan's wellness and health promotion program
• 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
• two or more physician-supervised weight loss attempts within the last 24 months
• consent to provide personal and medical information to the Plan

You may not qualify if:

• Any patient who does not meet criteria above or who declines to participate.

Sponsors & Collaborators

• University of Mississippi Medical Center: lead
• Allergan: collaborator

Study Sites (4)

Central Mississippi Medical Center Comprehensive Weight Management Program

Jackson, Mississippi, 39204, United States

Location

Oxford Bariatric

Oxford, Mississippi, 28677, United States

Location

Oxford Surgical & Bariatric Clinic,LLC.

Oxford, Mississippi, 38677, United States

Location

South Mississippi Surgical Weight Loss Center

Pascagoula, Mississippi, 39567, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katie S McClendon, Pharm.D.

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 14, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)