Blood Pressure, High Clinical Trial
Official title:
Dairy Foods and Blood Pressure in Multi-Ethnic Children
To prevent excess increases in blood pressure in children by providing two servings of dairy foods as snacks daily at school. We hypothesize that children who receive the two dairy snacks will exhibit significantly less of an increase in blood pressure over six months as compared to control children.
The primary aim of the study is to determine the impact of dairy foods on blood pressure;
however, we will also evaluate the effect of the intervention on body weight and
composition. Specifically, we will evaluate change in body mass index (BMI, kg/m2], waist
circumference in all subjects and body composition by bioelectrical impedance (BIA) in a
subset. We hypothesize that children receiving the dairy snacks will exhibit less increase
in BMI and body fat than control subjects. We are studying a group of children at high risk
for elevated blood lipids and glucose intolerance due to their racial/ethnic makeup and high
prevalence of overweight and obesity. Thus, we will evaluate the impact of the intervention
on blood lipids, glucose and insulin in a subset of subjects.
We hypothesize that children receiving the dairy foods will exhibit improvements in their
lipids, glucose and insulin as compared to control children. We also plan to determine their
eating habits through a 24 hour dietary recall at the beginning, middle and end of the
study, with 2 additional recalls for the subset at each time point. Dietary behavior and
self efficacy will be analyzed before and after the intervention through a questionnaire.
Physical activity levels will be assessed by a short physical activity questionnaire on all
students and through the utilization of accelerometers in the subset. Our control schools
will undergo the same testing, but will not receive any intervention.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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