Dairy Foods and Blood Pressure in Multi-Ethnic Children

Blood Pressure, High Clinical Trial

Official title:

Dairy Foods and Blood Pressure in Multi-Ethnic Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00495105
• Other study ID #: 1R01HL080967-01A2
• Secondary ID: 85861R01HL080967
• Status: Completed
• Phase: N/A
• First received: June 27, 2007
• Last updated: February 8, 2013
• Start date: August 2007
• Est. completion date: May 2009

Study information

• Verified date: February 2013
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2115
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Pressure, High
• Hypertension

Intervention

Behavioral:
• Two Servings of Dairy Snacks
2 servings of dairy products as snacks at school to third, fourth, and fifth grade students each day for 24 weeks. The serving size of each dairy snack is based on its calcium content with the goal of adding an extra 300 mg of calcium to the intervention group's daily intake.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Debra K. Sullivan, PhD, RD	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure Measurements		0, 3 and 6 Months	No
Secondary	Body Composition Measurements		0, 3 and 6 Months	No
Secondary	Dietary intake		0, 3 and 6 Months	No
Secondary	Blood Glucose, insulin, lipid profiles, and physical activity measurements by questionnaire and accelerometers to 10% of study population		0 and 6 Months	No