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Assessment of Outcomes Following Bariatric Surgery for Mississippi State Employees

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ClinicalTrials.gov Identifier: NCT01162668
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : May 15, 2018
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Katie McClendon, University of Mississippi Medical Center

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.


Condition or disease
Obesity

Study Type : Observational
Actual Enrollment : 165 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Assessment of Outcomes Following Bariatric Surgery for Mississippi State Employees
Study Start Date : April 2010
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Weight loss [ Time Frame: 0, 6, 12, and 24 months ]
    change in weight from baseline

  2. Body mass index (BMI) [ Time Frame: 0, 6, 12, and 24 months ]
    Change in body mass index (BMI) from baseline


Secondary Outcome Measures :
  1. ecomonic outcomes [ Time Frame: 0, 6, 12, and 24 months ]
    costs to the insurance plan were assessed

  2. Systolic blood pressure [ Time Frame: 0, 6, 12, and 24 months ]
    change in systolic blood pressure from baseline

  3. Diastolic blood pressure [ Time Frame: 0, 6, 12, and 24 months ]
    change in diastolic blood pressure from baseline

  4. Medication use [ Time Frame: 0, 6, 12, and 24 months ]
    Change in mean number of medications prescribed

  5. quality of life [ Time Frame: 0, 6, 12, and 24 months ]
    Impact of weight on quality of life (IWQOL-lite) questionnaire; tool assesses 5 domains of quality of life: physical function, self-esteem, sexual life, public distress, and work impact

  6. Work productivity [ Time Frame: 0, 6, 12, and 24 months ]
    Work productivity and activity impairment questionnaire: General Health v2.0 (WPAI:GH) assesses work productivity


Other Outcome Measures:
  1. Surgery-related adverse events [ Time Frame: 24 months ]
    Any surgery-related adverse events were noted



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162668


Locations
United States, Mississippi
Central Mississippi Medical Center Comprehensive Weight Management Program
Jackson, Mississippi, United States, 39204
Oxford Bariatric
Oxford, Mississippi, United States, 28677
Oxford Surgical & Bariatric Clinic,LLC.
Oxford, Mississippi, United States, 38677
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
  Study Documents (Full-Text)

Documents provided by Katie McClendon, University of Mississippi Medical Center:
Informed Consent Form  [PDF] April 13, 2012


Responsible Party: Katie McClendon, Clinical Assistant Professor, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01162668     History of Changes
Other Study ID Numbers: 41165
First Posted: July 14, 2010    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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