Obesity Clinical Trial
To determine the influences of diet and physical activity (PA) on total body fatness and regional fat distribution and the relationship of these to risk factors of cardiovascular disease during adolescence.
BACKGROUND:
Adult studies have shown that adiposity, especially visceral adipose tissue, and
cardiovascular (CV) fitness are key links between lifestyle factors like diet and exercise
on one hand, and CV disease on the other. However, very little is known about these links
during the juvenile years, when the processes leading to CV disease are at an early stage of
development.
The study is in response to a Program Announcement issued in March 1998 on Diet and
Cardiovascular Disease Risk in Children and Adolescents. The Program Announcement, jointly
issued by the National Institute of Nursing Research and the NHLBI, sought to encourage
research relevant to the development and/or testing of dietary interventions to improve the
cardiovascular disease (CVD) risk profiles in children and adolescents, especially those at
increased risk for CVD or for development of CVD risk factors because of genetics, family
history, socioeconomic status (SES), race/ethnicity, levels of blood cholesterol or blood
pressure, or other factors.
DESIGN NARRATIVE:
The study determines the relations of free-living diet and exercise to total body percent
fat ( percent BF), visceral adipose tissue and CV fitness in black and white boys and girls
of varying socioeconomic status (SES). The study also determines the relations of fatness
and fitness to different CVD risk factors. A total of 800 15 to 18 year olds, 200 in each
ethnic and gender subgroup will be recruited. Diet will be assessed with seven 24-hour
recalls, and exercise with two seven-day recalls and heart rate monitoring. Percent body fat
will be measured with dual-energy x-ray absorptiometry, visceral adipose tissue with
magnetic resonance imaging and CV fitness with a multi-stage treadmill test. Measurements
will be made of major fatness- and fitness-related CV disease risk factors (e.g., total
cholesterol:HDL cholesterol ratio, insulin, systolic blood pressure, left ventricular mass
indexed to height, fibrinogen). Multivariate and univariate analyses will be conducted to
determine relationships.
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