Clinical trial NCT00495105: Dairy Foods and Blood Pressure in Multi-Ethnic Children
Official title: Dairy Foods and Blood Pressure in Multi-Ethnic Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure, High
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2007-07-02
Enrollment: 2115
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Willingness to participate in the study
* Signed informed consent form by the parents and/or guardians
* Assent from the child

Exclusion Criteria:

* 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

Primary outcomes:
measure: Blood Pressure Measurements
timeFrame: 0, 3 and 6 Months
Secondary outcomes:
measure: Body Composition Measurements
timeFrame: 0, 3 and 6 Months
measure: Dietary intake
timeFrame: 0, 3 and 6 Months
measure: Blood Glucose, insulin, lipid profiles, and physical activity measurements by questionnaire and accelerometers to 10% of study population
timeFrame: 0 and 6 Months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Debra K. Sullivan, PhD, RD, LD
role: PRINCIPAL_INVESTIGATOR
References: