Dairy Foods and Blood Pressure in Multi-Ethnic Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,115
- 试验地点
- 2
- 主要终点
- Blood Pressure Measurements
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willingness to participate in the study
- •Signed informed consent form by the parents and/or guardians
- •Assent from the child
排除标准
- •Children with food allergies or other dietary requirements that restrict their ability to consume the snack
- •Children with a chronic medical condition that may influence blood pressure or calcium metabolism such as renal disease or type 1 diabetes mellitus
结局指标
主要结局
Blood Pressure Measurements
时间窗: 0, 3 and 6 Months
次要结局
- Body Composition Measurements(0, 3 and 6 Months)
- Dietary intake(0, 3 and 6 Months)
- Blood Glucose, insulin, lipid profiles, and physical activity measurements by questionnaire and accelerometers to 10% of study population(0 and 6 Months)
研究者
Debra K. Sullivan, PhD, RD
Chair, Midwest Dairy Professor of Clinical Nutrition
University of Kansas Medical Center
