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  ![](media/image1.wmf){width="2.8756944444444446in"             National Institute of
  height="1.1270833333333334in"}                                 Diabetes and Digestive and
                                                                 Kidney Diseases (NIDDK)
                                                                 http://www.niddk.nih.gov/

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EMBARGOED FOR RELEASE CONTACT:

Wednesday, November 16, 2005 Marcia Vital or Melissa McGowan

5:00 p.m. ET niddkdkocpl@mail.nih.gov

301-496-3583

# Number range CHAPTERLifestyle Modification Plus Medication More Effective Than Medication Alone for Weight Loss in Obese Adults

A new study shows that treatment with a lifestyle modification program
of diet, exercise and behavioral therapy when used in combination with
the weight loss medication sibutramine (Meridia®) resulted in
significantly greater weight loss among obese adults than treatment with
the medication alone. The study, conducted by researchers from the
University of Pennsylvania, appears in the November 17, 2005 issue of
*The New England Journal of Medicine* and was supported by the National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), one of
the National Institutes of Health (NIH).

"NIH is fighting the increasing problem of obesity in America by
supporting research that will result in better treatments and therapies
for weight loss and the prevention of obesity\'s associated diseases,
such as type 2 diabetes, heart disease, and some forms of cancer," says
NIH Director Elias A. Zerhouni, M.D.

"Lifestyle modification should be the first line of treatment for
obesity," says Susan Yanovski, M.D., director of the Obesity and Eating
Disorders Program for NIDDK, and author of an accompanying editorial in
the journal. "But for obese adults who can't lose enough weight to
improve their health, medication used as an adjunct can help."

"The take home message is that weight loss medications will be most
effective when they are combined with a reduced calorie diet and
increased physical activity," says Thomas A. Wadden, Ph.D., Professor of
Psychology in the Department of Psychiatry at the University of
Pennsylvania School of Medicine, and lead author of the study. "Weight
loss medication used alone can produce some weight loss, but lifestyle
modification treatment can help patients acquire skills to successfully
make changes in their diet and physical activity."

A total of 224 obese adults aged 18 to 65 years participated in the
one-year study. Participants were randomly assigned to one of four
groups: 1. weight loss medication alone; 2. lifestyle modification
alone; 3. weight loss medication plus lifestyle modification; and 4.
weight-loss medication plus brief physician-mediated therapy. The
researchers included the fourth treatment group to measure the
effectiveness of weight-loss medication combined with brief lifestyle
modification counseling delivered by primary care providers. The
researchers looked at this type of therapy as a possible model for
delivering lifestyle modification therapy in the setting of primary care
practice.

Participants in the lifestyle modification therapy group attended a
total of 30, 90-minute group meetings. During the meetings participants
were instructed to complete and share weekly assignments, which included
keeping detailed daily food and physical activity records. Participants
in the brief lifestyle modification counseling group met with primary
care physicians eight times for 10 to 15 minute visits, where they were
given homework assignments, which also included keeping daily food and
activity records. Participants in the weight-loss medication therapy
alone group also met with primary care physicians eight times for 10 to
15 minute visits, but were not instructed to keep food or activity
records and were provided only general information on diet and exercise.
Those participants in the combined therapy group received both the
lifestyle modification therapy and the weight-loss medication. All
groups were prescribed a 1200 to 1500 calorie diet and the same exercise
plan.

After one year, patients in the weight-loss medication plus lifestyle
group lost an average of more than 26 pounds -- more than double the
weight loss seen with medication alone (11 pounds). In addition, 73
percent of participants in the combined therapy group lost 5 percent or
more of their initial body weight, compared to 56 percent of
participants in the brief therapy plus weight-loss medication group, 53
percent of participants in the lifestyle modification alone group, and
42 percent of participants in the weight-loss medication alone therapy
group. More than half or 52 percent of people in the combined therapy
group lost 10 percent or more of their initial body weight compared to
29 percent of participants in the lifestyle modification alone group, 26
percent of participants in the brief therapy plus weight-loss medication
group, and 26 percent of participants in the weight-loss medication
alone group.

Interestingly, those participants in the combined therapy group who were
most successful were those who frequently recorded their food intake.
Those participants with high adherence to food intake record keeping
lost more than twice as much weight as those with low adherence (41.5
versus 17 pounds).

"Some people have questions about how they can do lifestyle
modification," says Dr. Wadden. "I think that a first step is to
complete daily food logs. Food records help people become aware of their
eating patterns and identifying areas for improvement." Dr. Wadden adds
that the second step to weight loss is to increase physical activity and
one of the best ways to do that is to obtain a pedometer to count steps
and gradually increase daily walking.

One limitation of the study is that it only included obese patients who
were otherwise healthy and excluded obese patients with health problems
possibly related to their obesity, such as hypertension, cardiovascular
disease, cerebrovascular disease, kidney disease, liver disease, and
diabetes. Because many obese patients also have other conditions that
can adversely affect their health, physicians should carefully monitor
patients enrolled in weight-loss programs that include weight-loss
medications.

The findings of the study are consistent with the NIH Obesity Clinical
Guidelines, which recommend that weight loss medications be used in a
supportive role to a comprehensive

program of behavioral treatment, diet therapy, and increased physical
activity. The NIH Obesity Clinical Guidelines state that the most
successful strategies for weight loss include calorie reduction,
increased physical activity, and behavioral therapy designed to improve
eating and physical activity habits. The Guidelines also recommend that
physicians prescribe a regimen of lifestyle therapy for at least six
months before adding weight-loss medication to the regimen. More
information on the NIH Obesity Clinical Guidelines is available on the
NIH web site at
<http://www.nhlbi.nih.gov/guidelines/obesity/ob_home.htm>.

According to data from the 1999 to 2000 National Health and Examination
Survey (NHANES), approximately 65 percent of Americans aged 20 years or
older are overweight with 31 percent of adults obese as defined by body
mass index (BMI). BMI is a calculation that takes into account both
height and weight. Overweight is defined as having a BMI of 25 to 29.9
kg/m^2^. Obesity is defined as having a BMI of 30 kg/m^2^ or higher. The
NIDDK Weight-control Information Network fact sheet, *Statistics Related
to Overweight and Obesity*
(<http://win.niddk.nih.gov/statistics/index.htm>) provides more
information.

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*NIDDK, part of the National Institutes of Health (NIH), conducts and
supports* *research on* *diabetes;* *endocrine and metabolic diseases;*
*digestive diseases,* *nutrition, and obesity;* *and* *kidney,*
*urologic* *and hematologic* *diseases.* *Spanning the full spectrum of
medicine and afflicting people of all ages and ethnic groups, these
diseases encompass some of the most common, severe, and disabling
conditions affecting Americans.*

*The National Institutes of Health (NIH) -- The Nation's Medical
Research Agency -- includes 27 Institutes and Centers and is a component
of the U.S. Department of Health and Human Services (HHS). The NIH is
the primary Federal agency for conducting and supporting basic,
clinical, and translational medical research, and it investigates the
causes, treatments, and cures for both common and rare diseases. For
more information about NIH and its programs, visit
[http://www.nih.gov](http://www.nih.gov/).*