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(LNE-0602) The Natural History of Obesity and Associated Conditions Before, During, and After Treatment with Conventional Therapies

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The Natural History of Obesity and Associated Conditions Before, During, and After Treatment with Conventional Therapies (LNE-0602)

Principal Investigator:
Lisa M. Neff M.D.

Jeanne Walker ANP-C
Diane Meehan MS, RD
Suzanne Magnotta MS, RD
Allegra Grossman M.D.
Jan L. Breslow M.D.

Contact Information:
Lisa Neff
The Rockefeller University
1230 York Avenue
New York, NY 10021
Telephone: (212)327-7445
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
Excess body weight is a common condition that is often very difficult to treat. In fact, 65% of American adults are currently overweight or obese. Body weight is influenced by many things, including diet, physical activity, and genetic, metabolic, and environmental factors. In addition, an individual’s response to conventional weight management treatments (such as diet, exercise, medication, or weight loss surgery) is also likely to be affected by his or her genetic makeup, metabolic characteristics, and environment.

As a result, individuals are likely to respond differently to different treatments. However, we currently have a limited understanding of how and why this occurs. As a result, we are often unable to predict which individuals will have successful weight loss and long-term weight maintenance with a particular therapy.

The aim of this long-term study is to determine why some people respond well to some conventional therapies but not others. Eventually, it is hoped that this study will provide vital information that will allow health care providers to match patients with the types of treatments that are most likely to help them manage their weight.

Detailed Description of Protocol:
If you decide to take part in this study, you will be provided with individualized counseling and weight management treatment, according to the current standard of care and your own preferences regarding treatment.

Appropriate treatment options will be discussed with you, and you will have the opportunity to select the treatment option or options that best suit your needs and preferences.

These treatment options may include:

• screening for weight-related medical conditions

• treatment of or referral for care of weight-related medical conditions

• outpatient appointments for routine weight management follow-up and care, as often as is medically indicated

• individualized counseling about diet and physical activity

• weight management skills training

• weight loss support groups

• a very low calorie diet (meal replacements)

• prescriptions for weight loss medications

• counseling about weight loss surgery, if indicated, and referral for surgical evaluation for interested individuals

If you decide to participate in this study, you will also be asked to come to Rockefeller University Hospital Outpatient Research Center at least once every four months (+/- one month) for testing.

Testing appointments will be in addition to routine appointments that will be scheduled as needed for your ongoing weight-related care.

What specifically makes a person eligible for the study?
You may be eligible to enter this study:

• You are an adult, age 18 or over

• You have a body mass index (BMI) of at least 25 kg/m2 (see below for more information)

• You have recently had a BMI of 25 kg/m2 or more, or you have weight-related medical conditions that are likely to improve with weight loss


18 years and older

Children permitted to participate:

Potential Benefits.....
During this study, you will have a full physical exam and multiple blood tests during the study. If any abnormalities are uncovered during testing, you will be made aware and a copy of the standard New York-certified laboratory tests will be made available to you.

You will also receive behavioral skills training, which may help you manage your weight over the long term.

Your expected weight loss will depend on which treatment option you pursue. In general, individuals who follow a low-calorie diet and exercise program can typically lose between 3% and 7% of their starting weights, although some individuals lose more or less than this.

Individuals who combine diet, exercise, and weight loss medication typically lose between 5% and 10% of their starting weights, with some individuals losing more weight.

Individuals who follow a physician-supervised very low calorie diet typically lose between 15% and 20% of their starting weights, although weight regain often occurs.

For weight loss surgery, average weight losses typically range from about 20% to 35% of starting weight, depending on the procedure selected. Even small weight losses of 5% to 10% of starting weight can produce significant improvements in many weight-associated medical conditions, such as high blood pressure, high cholesterol, and diabetes.

Finally, your participation in this study will help us to learn how different people respond to different weight management treatments. It is hoped that this information may eventually be used to help doctors match patients with the treatments that are most likely to help them manage their weight. You and others may benefit from this knowledge in the future.

There is no cost to you for being in this research study.
You will not be paid to be part of this study.