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

NCT01929850 | Withdrawn Phase 4

• 1 other identifier: 12-10409
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

• body mass index (BMI)

  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 .

  One year post randomization (% of patients with reduction in BMI by 5 points)

Secondary Outcomes (1)

• quality of life

  One year after study completion

Study Arms (2)

Surgery

ACTIVE COMPARATOR

Sleeve gastrectomy laparoscopic surgery plus Weight Watchers for morbidly obese patients

Procedure: Laparscopic Sleeve Gastrectomy; Behavioral: Weight Watchers Program

Control

OTHER

Weight Watchers Program for morbidly obese patients.

Behavioral: Weight Watchers Program

Interventions

Laparscopic Sleeve Gastrectomy PROCEDURE

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.

Surgery

Weight Watchers Program BEHAVIORAL

Intensive medically supervised nutritional and exercise therapy

Also known as: Weight Watchers 360

Control; Surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, age 18-65 years
• Meeting the criteria as outlined in Part 2 A (Synopsis) of a medically underserved, rural, poor or underrepresented minority.
• 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 \[systolic blood pressure of ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg (or both) or on treatment for hypertension\]
• History of obesity for at least 2.5 years
• History of failure with non-surgical weight loss methods
• Agree to comply with the substantial dietary restrictions and exercise program required by the procedure
• Signed approval by physician and psychologist of subject's physical and mental suitability for bariatric surgery
• 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.
• 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.
• Willingness to participate in weekly visits with Weight Watchers International local program.

You may not qualify if:

• Subject history of inflammatory disease of the gastrointestinal tract including Crohn's disease or ulcerative colitis
• Significant known esophageal disease including grade 3-4 esophagitis, active gastric ulcer disease or active duodenal ulcer disease
• Severe coagulopathy, upper GI bleeding conditions such as esophageal or gastric varices, congenital or acquired telangiectasia
• Congenital or acquired anomalies of the GI tract such as atresias or stenoses.
• Severe cardiopulmonary disease or other serious organic disease including HIV or cancer
• 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
• Current alcohol or drug addiction
• 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
• Previous gastric, esophageal, pancreatic, or bariatric surgery
• Infection anywhere in the body at the time of the procedure
• Subject history of scleroderma, amyloidosis
• Thyroid disease which is not controlled with medication
• Hormonal or genetic cause for the obese state.
• History of cancer other than localized basal cell carcinoma.
• Myocardial infarction or cerebrovascular accident within past year.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF/San Francisco General Hospital

San Francisco, California, 94132/94110, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John P Cello, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: August 28, 2013
• Primary Completion: October 1, 2018
• Last Updated: May 8, 2015

Record last verified: 2015-05

Locations

US (1)