Dairy Foods and Blood Pressure in Multi-Ethnic Children

Not Applicable

Completed

• Conditions: Blood Pressure, High
• Interventions: Behavioral: Two Servings of Dairy Snacks

• Registration Number: NCT00495105
• Lead Sponsor: Debra K. Sullivan, PhD, RD

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.

Study Timeline

• Study First Submitted: 2007-06-27
• Study First Submitted QC: 2007-06-29
• Study First Posted: 2007-07-02
• Study Start: 2007-08
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-08
• Last Update Posted: 2013-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2115

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Two Servings of Dairy Snacks	Two Servings of Dairy Snacks	Intervention group received two servings of dairy food per day as a snack at school for 6 months as well as nutrition education.

Primary Outcome Measures

Name	Time	Method
Blood Pressure Measurements	0, 3 and 6 Months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States