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Sponsors and Collaborators: |
University of Kansas National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | University of Kansas |
ClinicalTrials.gov Identifier: | NCT00495105 |
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.
Condition | Intervention |
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Blood Pressure, High |
Behavioral: Procedure - Two Servings of Dairy Food Daily at School |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Dairy Foods and Blood Pressure in Multi-Ethnic Children |
Estimated Enrollment: | 2600 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Behavioral: Procedure - Two Servings of Dairy Food Daily at School
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.
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2: No Intervention
Control Group
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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.
Ages Eligible for Study: | 8 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | University of Kansas Medical Center ( Debra K. Sullivan, PhD, RD, LD ) |
Study ID Numbers: | 1 R01 HL080967-01A2, 8586 |
Study First Received: | June 27, 2007 |
Last Updated: | January 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00495105 History of Changes |
Health Authority: | United States: Institutional Review Board |
Calcium, Dietary Vascular Diseases Hypertension |
Vascular Diseases Cardiovascular Diseases Hypertension |