Dairy Foods and Blood Pressure in Multi-Ethnic Children
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Dairy Foods and Blood Pressure in Multi-Ethnic Children|
- Blood Pressure Measurements [ Time Frame: 0, 3 and 6 Months ] [ Designated as safety issue: No ]
- Body Composition Measurements [ Time Frame: 0, 3 and 6 Months ] [ Designated as safety issue: No ]
- Dietary intake [ Time Frame: 0, 3 and 6 Months ] [ Designated as safety issue: No ]
- Blood Glucose, insulin, lipid profiles, and physical activity measurements by questionnaire and accelerometers to 10% of study population [ Time Frame: 0 and 6 Months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Experimental: 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.
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.
No Intervention: No Dairy Snacks
Control Group did not receive any snacks or education.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495105
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Debra K. Sullivan, PhD, RD, LD||University of Kansas Medical Center|