Laparoscopic Sleeve Gastrectomy Plus Weight Watchers vs. Weight Watchers Alone in Underserved Minority Women
Laparoscopic Sleeve Gastrectomy Plus Weight Watchers vs. Weight Watchers Alone in Underserved Minority Women
Obesity is a costly multi-etiology world disease of fat storage. Morbid obesity is defines as
 greater than 100 pounds overweight and/or greater than 200 % of ideal body weight. Chronic
 underemployment, poor housing, child abuse, limited education, stress and anxiety are all
 associated with maternal morbid obesity. These latter conditions leave many patients in a
 state of economic, social and emotional poverty with need for life-long welfare support. For
 patients with true morbid obesity a standard surgical procedure is currently the procedure of
 choice especially among patients who fail standard medical intervention. The major procedures
 performed for morbid obesity include the Roux-en-Y gastric bypass, sleeve gastrectomy and
 laparoscopic band procedure. The sleeve gastrectomy is purely a restrictive procedure without
 malabsorptive components which involves one single staple line and can be performed
 laparoscopically in less than one hour. While these surgical procedures are recognized as
 "standard" procedures for patient who have failed medical treatment and are "covered" by most
 health plans, access to these procedures is limited for the medically underserved, rural,
 poor or underrepresented minorities since national, state and municipal health plans either
 provide minimal coverage or no coverage at all for surgery for morbid obesity. Reimbursement
 to providers offering these procedures is minimal and thus access to bariatric surgery is
 unlikely within a timely fashion.
Obesity is a costly multi-etiology world disease of fat storage. Morbid obesity is defined as
 greater than 100 pounds overweight and/or greater than 200 % of ideal body weight. A commonly
 used measure of body mass is the Body Mass Index, BMI, which is the weight in kilograms
 divided by the body surface area in meters squared (kg/m²). A BMI greater than or equal to 40
 is defined as morbid obesity. Morbid obesity is associated with an extraordinarily high
 increased risk of mortality principally from cardiovascular and cerebrovascular diseases.
 Morbidly obese patients routinely develop early hypertension, hypercholesterolemia, and
 diabetes mellitus. Currently, we estimate that approximately 15% of the adult U.S. population
 is morbidly obese. Morbid obesity is certainly not solely a disease of the economically
 advantaged. In developed countries where calories are readily available and relatively
 inexpensive, morbid obesity is disproportionately noted in culturally and economically
 disadvantaged people. Most disturbing, morbid obesity is especially prevalent among lower
 socioeconomic women between the ages of 21-40 years, when such women are bearing and rearing
 children. Morbid obesity for this patient population is clearly associated with the
 "Metabolic Syndrome" including such documented medical conditions such as diabetes,
 hypertension, sleep apnea, hypercholesterolemia and ultimately early onset heart disease and
 chronic lung disease. In addition, chronic underemployment, poor housing, child abuse,
 limited education, stress and anxiety are all associated with maternal morbid obesity. These
 latter conditions leave many patients in a state of economic, social and emotional poverty
 with need for life-long welfare support. The impact on the next generation reared by these
 morbidly obese underserved minority patients is likely to be dire.

 Currently the major treatment programs available for morbid obesity including supervised
 dietary programs, pre-planned meals, positive reinforcement, and even pharmacological
 therapies are costly and have a very low permanent success rate. For patients with true
 morbid obesity a standard surgical procedure is currently the procedure of choice especially
 among patients who fail standard medical intervention.

 One of the best known international programs is Weight Watchers International. Recent studies
 have documented weight loss of greater to or equal to 5 kg over a 12 month period.

 Weight Watchers is an international company based in the United States that offers various
 products and services to assist weight loss and maintenance. It was founded in 1963 and
 operates in about 30 countries world-wide. The Weight Watcher's philosophy is to use a
 science-driven approach to help participants lose weight by forming helpful habits, eating
 smarter, getting more exercise and providing support. Weight Watchers uses the PointPlus
 System. This system is a calculation based on dietary protein, carbohydrates, fat and fiber.
 The weekly program focuses on assisting members in creating a caloric deficit to lose weight.
 The Weight Watchers Program is designed to result in a weight loss of ½ to 2 pounds per week.
 Members of Weight Watchers will be expected to go to hourly weekly meetings for selected
 topic discussions and to "weigh-in". Membership in the Weight Watchers Program includes not
 only weekly meetings, but also access to the Weight Watchers online, access to the Weight
 Watchers eTools and access to the Weight Watchers mobile applications.

 Weekly Meeting Process:

 For the half hour prior to start-times, the participant weighs in. Weight is recorded into a
 computer to track the participant's progress. The topic of the week is announced (i.e. The
 Sleep-Weight Loss Connection). The weekly topic is discussed amongst members and the
 moderator (who is a Weight Watchers lifetime member) focuses on the relationship of the topic
 to weight loss. All are encouraged to verbally participate but it is not a requirement. The
 moderator rewards members who have reached certain goals. Members also discuss their progress
 throughout the past week. At the end of the meeting, the moderator enforces the adoption of
 life-style changes to incorporate the topic of the week into daily life. Members are never
 pressured into buying informational products, but can do so if they decide to.

 The major procedures performed for morbid obesity include the Roux-en-Y gastric bypass,
 sleeve gastrectomy and laparoscopic band procedure. The sleeve gastrectomy is a permanent
 restrictive procedure without malabsorptive components which involves a single staple line
 and can be performed laparoscopically in less than one hour.

 While these surgical procedures are recognized as "standard" procedures for patient who have
 failed medical treatment and are "covered" by most health plans, access to these procedures
 is limited for the medically underserved, rural, poor or underrepresented minorities since
 national, state and municipal health plans either provide minimal coverage or no coverage at
 all for surgery for morbid obesity. Often, these patients wait years for elective bariatric
 procedures. Reimbursement to providers offering these procedures is minimal and thus access
 to bariatric surgery is unlikely within a timely fashion.

 The laparoscopic sleeve gastrectomy involves the placement of 5 trocars. First, the V-shaped
 liver suspension technique (V-LIST) is used to gain a broad operative view of the
 gastroesophageal junction[11-12] and a silicone Penrose drain is inserted into the peritoneal
 cavity and stapled to the pars condensa of the lesser omentum and parietal peritoneum using
 2-0 Prolene (Ethicon) for liver retraction. The left lobe of liver is retracted with the
 V-shaped suspension technique. The greater curvature of stomach is freed beginning from 6 cm
 proximal to the pylorus to the angle of His with the harmonic scalpel (Ethicon). Care is
 taken to preserve the gastroepiploic vessels. A bougie (36-40 Fr) is placed in the stomach
 against the lesser curvature to guide the stapling. Gastric resection is performed with a
 stapler (Echelon 60, Ethicon) along a line parallel to the bougie beginning from 6 cm
 proximal to the pylorus and extending to the cardia. The remnant stomach is removed from the
 abdominal cavity by slightly enlarging the incision where the Versaport cannula has been
 placed. A leak check may be performed at the same time by insufflating with a gastroscope
 with the remnant gastric section submerged in irrigation fluid and by infusing sterile
 methylene blue through a nasogastric tube. The staple line may also be oversewn (3-0 Vicryl,
 Ethicon), only along the bleeding and leakage areas, or areas with the potential for such
 complications. A nasogastric decompression tube may be placed to monitor bleeding and an
 intraperitoneal drain placed under an anastomotic stoma.

 For the purposes of this study we will consider the following to meet the criteria of
 populations that are underserved, rural, poor and/or underrepresented:

 Medically Underserved Populations Populations that have inadequate access to, or reduced
 utilization of, high-quality cancer prevention, screening and early detection, treatment,
 and/or rehabilitation services. Included are rural, low-literacy, and low-income populations.
 An effort to clarify and further define "medically underserved" is currently underway at NIH.

 Rural The working definition of rural, taken from the U.S. Census Bureau, is somewhat vague.
 "Rural" is defined as territory, populations, and housing units not classified as "urban."
 The Census Bureau's definition of "urban" is places of 2,500 or more persons incorporated as
 cities, villages, boroughs, and towns.

 Poor (Low Income)

 The 1998 DHHS Poverty Guidelines (also referred to as the "Federal poverty level") define a
 poverty threshold as an annual income of approximately $10,000 for a single individual and an
 annual income of approximately $20,000 for a family of 4 (Federal Register 63, #36, February
 24, 1998, pp 9235-9238).

 Underrepresented Minority

 For NCI purposes, a person is an underrepresented minority if he or she belongs to a minority
 group that is underrepresented in biomedical and behavioral science careers, based on their
 minority group's representation in the total population. Using this definition and available
 data on minority representation in the health professions, science, and engineering, blacks,
 Hispanics, American Indian or Alaskan Native, and Pacific Islanders are classified as
 underrepresented minorities. Asians are not considered to be an underrepresented minority.

 The bariatric surgical procedures, including the sleeve gastrectomy, performed at UCSF by the
 principal investigator, Dr. Stanley J. Rogers, (Chief of Minimally Invasive Surgery and
 Surgical Director of Bariatric Surgery) for the past 5 years, has a documented zero percent
 mortality, a mean 98% laparoscopic completion rate and a mean duration of hospitalization
 under 3 days. The cost of these procedures also is relatively inexpensive while requiring
 less than 2 hours of surgery time.

 We propose to randomize patients to a surgical arm (sleeve gastrectomy) plus the Weight
 Watchers program or to the Weight Watchers program alone. We will employ extensive metrics to
 assess the impact of laparoscopic sleeve gastrectomy surgery plus Weight Watchers vs. Weight
 Watchers Program alone monitoring for 12 months the following:

 Weight reduction efficacy Self-worth assessment Health care cost Economic productivity Stress
 and anger Intergenerational impact
Inclusion Criteria: Patients who are morbidly obese.

 1. Female, age 18-65 years

 2. Meeting the criteria as outlined in Part 2 A (Synopsis) of a medically underserved,
 rural, poor or underrepresented minority.

 3. BMI > 40 and < 55, or BMI > 35 and <55 with one or more significant comorbidities.
 Co-morbidities are defined as diabetes, pulmonary disease, cardiac disease, or
 hypertension [systolic blood pressure of ≥140 mm Hg or diastolic blood pressure ≥90 mm
 Hg (or both) or on treatment for hypertension]

 4. History of obesity for at least 2.5 years

 5. History of failure with non-surgical weight loss methods

 6. Agree to comply with the substantial dietary restrictions and exercise program
 required by the procedure

 7. Signed approval by physician and psychologist of subject's physical and mental
 suitability for bariatric surgery

 8. Understands risks of procedures, agree to follow protocol requirements, including
 signing informed consent, returning for follow-up visits and completing all required
 testing, completing diet and behavior modification counseling.

 9. Subject is a resident within the state of California or the city of Bangkok, Thailand
 and will likely remain so for a 2 year period of time.

 10. Willingness to participate in weekly visits with Weight Watchers International local
 program.

 Exclusion Criteria:

 1. Subject history of inflammatory disease of the gastrointestinal tract including
 Crohn's disease or ulcerative colitis

 2. Significant known esophageal disease including grade 3-4 esophagitis, active gastric
 ulcer disease or active duodenal ulcer disease

 3. Severe coagulopathy, upper GI bleeding conditions such as esophageal or gastric
 varices, congenital or acquired telangiectasia

 4. Congenital or acquired anomalies of the GI tract such as atresias or stenoses.

 5. Severe cardiopulmonary disease or other serious organic disease including HIV or
 cancer

 6. Currently pregnant or nursing. Potentially childbearing (i.e. not post-menopausal or
 surgically sterilized) and not willing to use an effective method of contraception for
 the next 12 months

 7. Current alcohol or drug addiction

 8. Mentally retarded or emotionally unstable, or exhibits psychological characteristics
 which, in the opinion of the investigator or psychologist/psychiatrist, make the
 subject a poor candidate for this procedure

 9. Previous gastric, esophageal, pancreatic, or bariatric surgery

 10. Infection anywhere in the body at the time of the procedure

 11. Subject history of scleroderma, amyloidosis

 12. Thyroid disease which is not controlled with medication

 13. Hormonal or genetic cause for the obese state.

 14. History of cancer other than localized basal cell carcinoma.

 15. Myocardial infarction or cerebrovascular accident within past year.

 16. Angina pectoris.

 17. Severe coagulopathy (prothrombin time > 3 seconds over control or platelet count <
 100,000)

 18. Gastroparesis or pyloric stenosis.

 19. Lesions with increased risk of bleeding.

 20. Severe cardiopulmonary disease or other serious organic disease, including HIV or
 cancer.

 21. Congestive heart failure.

 22. Uncontrolled hypertension (systolic > 150 or diastolic > 100).

 23. Severe or advanced liver disease (such as cirrhosis, chronic hepatitis, portal
 hypertension, etc.).

 24. Severe reflux disease.

 25. Active, continuous alcohol consumption (> 80 gm/day of ethanol) or chronic illicit
 drug use within the last 3 years.

 26. Currently on prescription or over the counter diet drugs.

 27. Chronic therapy with aspirin, NSAID or anticoagulants.

 28. Not ambulatory.

 29. Participating in another ongoing clinical trial in which concomitant diagnosis or
 therapeutic intervention would adversely affect the integrity of the clinical trial.

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