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Completed

NCT Number: NCT01162668

Assessment of Outcomes Following Bariatric Surgery for Mississippi State Employees

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Central Mississippi Medical Center Comprehensive Weight Management Program, Jackson, Mississippi, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  1. Surgery-related adverse events

    Time frame: 24 months

    Any surgery-related adverse events were noted

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Collaborators

  • Allergan

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 14, 2010
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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