Dairy Foods and Blood Pressure in Multi-Ethnic Children
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| First Received Date ICMJE | June 27, 2007 | ||||
| Last Updated Date | February 8, 2013 | ||||
| Start Date ICMJE | August 2007 | ||||
| Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Blood Pressure Measurements [ Time Frame: 0, 3 and 6 Months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Blood Pressure Measurements [ Time Frame: 0, 3 and 6 Months ] | ||||
| Change History | Complete list of historical versions of study NCT00495105 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Dairy Foods and Blood Pressure in Multi-Ethnic Children | ||||
| Official Title ICMJE | Dairy Foods and Blood Pressure in Multi-Ethnic Children | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Blood Pressure, High | ||||
| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 2115 | ||||
| Completion Date | May 2009 | ||||
| Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 8 Years to 12 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00495105 | ||||
| Other Study ID Numbers ICMJE | 1 R01 HL080967-01A2, 8586, 1R01HL080967-01A2 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Debra K. Sullivan, PhD, RD, University of Kansas Medical Center Research Institute | ||||
| Study Sponsor ICMJE | Debra K. Sullivan, PhD, RD | ||||
| Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Kansas | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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