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Laparoscopic Sleeve Gastrectomy Plus Weight Watchers vs. Weight Watchers Alone in Underserved Minority Women

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ClinicalTrials.gov Identifier: NCT01929850
Recruitment Status : Withdrawn (Scientific/feasibility approval required prior to IRB review)
First Posted : August 28, 2013
Last Update Posted : May 8, 2015
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: Laparscopic Sleeve Gastrectomy Behavioral: Weight Watchers Program Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bariatric Surgery Plus Weight Watchers vs. Weight Watchers in Underserved Minorities: Randomized Controlled Cross-over Trial
Estimated Primary Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: Surgery
Sleeve gastrectomy laparoscopic surgery plus Weight Watchers for morbidly obese patients
Procedure: Laparscopic Sleeve Gastrectomy
The laparoscopic sleeve gastrectomy involves the placement of 5 trocars. 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 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 placed to monitor bleeding and an intraperitoneal drain was placed under an anastomotic stoma.

Behavioral: Weight Watchers Program
Intensive medically supervised nutritional and exercise therapy
Other Name: Weight Watchers 360

Control
Weight Watchers Program for morbidly obese patients.
Behavioral: Weight Watchers Program
Intensive medically supervised nutritional and exercise therapy
Other Name: Weight Watchers 360




Primary Outcome Measures :
  1. body mass index (BMI) [ Time Frame: One year post randomization (% of patients with reduction in BMI by 5 points) ]
    Comparison of body mass index (BMI) in underserved young women treated with laparoscopic sleeve gastrectomy plus Weight Watchers vs. Weight Watchers alone for the treatment of morbid obesity .


Secondary Outcome Measures :
  1. quality of life [ Time Frame: One year after study completion ]
    Determine the effect of treatment on quality of life, employability, income levels, overall costs to society and co-morbidities



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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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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): NCT01929850


Locations
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United States, California
UCSF/San Francisco General Hospital
San Francisco, California, United States, 94132/94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: John P Cello, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01929850    
Other Study ID Numbers: 12-10409
First Posted: August 28, 2013    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight