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临床试验/NCT00495105
NCT00495105已完成不适用

Dairy Foods and Blood Pressure in Multi-Ethnic Children

Debra K. Sullivan, PhD, RD2 个研究点 分布在 1 个国家目标入组 2,115 人开始时间: 2007年8月最近更新:
适应症

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

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

发起方
Debra K. Sullivan, PhD, RD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Debra K. Sullivan, PhD, RD

Chair, Midwest Dairy Professor of Clinical Nutrition

University of Kansas Medical Center

研究点 (2)

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