Bariatric Surgery Plus Weight Watchers vs. Weight Watchers in Underserved Minorities: Randomized Controlled Cross-over Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- body mass index (BMI)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients who are morbidly obese.
- •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.
排除标准
- •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.
- •Angina pectoris.
- •Severe coagulopathy (prothrombin time > 3 seconds over control or platelet count < 100,000)
- •Gastroparesis or pyloric stenosis.
- •Lesions with increased risk of bleeding.
- •Severe cardiopulmonary disease or other serious organic disease, including HIV or cancer.
- •Congestive heart failure.
- •Uncontrolled hypertension (systolic > 150 or diastolic > 100).
- •Severe or advanced liver disease (such as cirrhosis, chronic hepatitis, portal hypertension, etc.).
- •Severe reflux disease.
- •Active, continuous alcohol consumption (> 80 gm/day of ethanol) or chronic illicit drug use within the last 3 years.
- •Currently on prescription or over the counter diet drugs.
- •Chronic therapy with aspirin, NSAID or anticoagulants.
- •Not ambulatory.
- •Participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of the clinical trial.
结局指标
主要结局
body mass index (BMI)
时间窗: 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 .
次要结局
- quality of life(One year after study completion)