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CompletedNCT01162668Updated May 15, 2018

Assessment of Outcomes Following Bariatric Surgery for Mississippi State Employees

An observational study in Obesity, sponsored by University of Mississippi Medical Center. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-15.

Sponsored by University of Mississippi Medical Center · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
165
Ages
18 Years and older
Sex
All
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Study 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).

  1. 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.
  1. 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.

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Conditions studied

  • Obesity

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Keywords

  • bariatric surgery
  • obesity
  • outcomes
03

In context

Obesity

6,297 studies on the registry are indexed under Obesity; 1,693 are open to participants now.

This study's enrollment of 165 is above the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Mississippi Medical Center is the lead sponsor of 125 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

Exclusion Criteria:

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

Observational model
Other
Time perspective
Prospective
Enrollment
165 participants (actual)
06

What researchers measure

Primary outcomes

  1. Weight loss

    change in weight from baseline

    Time frame: 0, 6, 12, and 24 months

  2. Body mass index (BMI)

    Change in body mass index (BMI) from baseline

    Time frame: 0, 6, 12, and 24 months

Secondary outcomes

  1. ecomonic outcomes

    costs to the insurance plan were assessed

    Time frame: 0, 6, 12, and 24 months

  2. Systolic blood pressure

    change in systolic blood pressure from baseline

    Time frame: 0, 6, 12, and 24 months

  3. Diastolic blood pressure

    change in diastolic blood pressure from baseline

    Time frame: 0, 6, 12, and 24 months

  4. Medication use

    Change in mean number of medications prescribed

    Time frame: 0, 6, 12, and 24 months

  5. quality of life

    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

    Time frame: 0, 6, 12, and 24 months

  6. Work productivity

    Work productivity and activity impairment questionnaire: General Health v2.0 (WPAI:GH) assesses work productivity

    Time frame: 0, 6, 12, and 24 months

Other outcomes

  1. Surgery-related adverse events

    Any surgery-related adverse events were noted

    Time frame: 24 months

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Study locations

4 sites
  • Central Mississippi Medical Center Comprehensive Weight Management Program
    Jackson, Mississippi 39204, United States
  • Oxford Bariatric
    Oxford, Mississippi 28677, United States
  • Oxford Surgical & Bariatric Clinic,LLC.
    Oxford, Mississippi 38677, United States
  • South Mississippi Surgical Weight Loss Center
    Pascagoula, Mississippi 39567, United States
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References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 5, 2010
  • Informed consent form · Apr 13, 2012

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01162668
Lead sponsor
University of Mississippi Medical Center
Collaborators
Allergan
Responsible party
Katie McClendon (Clinical Assistant Professor, University of Mississippi Medical Center) — Principal investigator
First posted
Jul 14, 2010
Start date
Apr 2010
Primary completion
Jun 2014
Completion
Jun 2014
Last update
May 15, 2018

Study contacts

Katie S McClendon, Pharm.D.
principal investigator · University of Mississippi Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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