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Once the Diabetes Prevention Program finished,
Dr. Hayward joined the investigative team of the
Look Ahead program, which is studying lifestyle
changes as they affect people with Type 2 Diabetes.
The study expects to follow some of the participants
for 12 years.
The website of the United States National Institute
of Diabetes & Digestive & Kidney Diseases
of the National Institutes of Health (NIDDK) describes
the program in part as follows:
What Is Look AHEAD?
Look AHEAD (Action For Health in Diabetes) is
a multicenter randomized clinical trial to examine
the effects of a lifestyle intervention designed
to achieve and maintain weight loss over the long
term through decreased caloric intake and exercise.
Look AHEAD is focusing on the disease most affected
by overweight and obesity, type 2 diabetes, and
on the outcome that causes the greatest morbidity
and mortality, cardiovascular disease.
Look AHEAD Background
Overweight (Body Mass Index (BMI) 25.0-29.9)
and obesity (BMI greater than or equal to 30.0)
now affect more than 50% of adult Americans, reflecting
a rapid increase in prevalence. Obesity also is
associated with a host of significant comorbid
conditions, including diabetes and cardiovascular
disease. Many studies have demonstrated that short-term
weight loss has beneficial effects on risk factors
such as high blood pressure and cholesterol. However,
observational studies have raised concerns about
negative effects of weight loss and weight cycling.
Some of these studies suggest increased, not decreased,
mortality; however, most cannot distinguish voluntary
from involuntary weight loss.
In 1997, a workshop was convened by the National
Institutes of Health (NIH) and the Centers for
Disease Control and Prevention (CDC) to address
this issue. Workshop participants concluded that
only a randomized clinical trial of intentional
weight loss could provide needed guidance on the
risks and benefits of weight loss to inform rational
clinical and public health policy. They suggested
that such a study should focus on obese individuals
who already had a comorbid medical illness, both
because of the clear public health recommendation
of weight loss for such individuals and because
of their increased risk of adverse health-related
outcomes. A trial was considered feasible since
several large randomized multi-center trials have
demonstrated substantial decreases in weight and
increases in activity level for as long as three
years. Acting on this recommendation, the NIDDK
issued an RFA (DK-98-019) for Clinical Centers
and an RFA (DK-98-020) for a Data Coordinating
Center for a study then called SHOW (the Study
of Health Outcomes of Weight Loss). This study
has evolved into the Look AHEAD trial.
Look AHEAD Objectives
The Look AHEAD trial has completed enrollment
of 5,145 obese patients with type 2 diabetes.
At study entry, participants were randomly assigned
to one of two interventions, the Lifestyle Intervention
or Diabetes Support and Education. They will be
followed for a total period of up to 11.5 years.
The primary aim of Look AHEAD is to study the
effects of the two interventions on major cardiovascular
events: heart attack, stroke and cardiovascular-related
death. Look AHEAD also will investigate the impact
of the interventions on other cardiovascular disease-related
outcomes, cardiovascular risk factors, and all-cause
mortality. Additional outcomes include: diabetes
control and complications, fitness, general health,
health-related quality of life and psychological
outcomes. The cost and cost effectiveness of the
Lifestyle Intervention relative to Diabetes Support
and Education will be assessed.
A number of Look AHEAD ancillary studies will
elucidate additional topics, such as fatty liver
disease, sleep apnea and eating disorders in Look
AHEAD participants.
To view the Look AHEAD protocol, please go to
the study
website
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