Dairy Foods and Blood Pressure in Multi-Ethnic Children

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Debra K. Sullivan, PhD, RD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00495105
First received: June 27, 2007
Last updated: February 8, 2013
Last verified: February 2013
  Purpose

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
Blood Pressure, High
Behavioral: Two Servings of Dairy Snacks

Study Type: Interventional
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

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Blood Pressure Measurements [ Time Frame: 0, 3 and 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2115
Study Start Date: August 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495105

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Debra K. Sullivan, PhD, RD
Investigators
Principal Investigator: Debra K. Sullivan, PhD, RD, LD University of Kansas
  More Information

No publications provided

Responsible Party: Debra K. Sullivan, PhD, RD, Chair, Midwest Dairy Professor of Clinical Nutrition, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00495105     History of Changes
Other Study ID Numbers: 1 R01 HL080967-01A2, 8586, 1R01HL080967-01A2
Study First Received: June 27, 2007
Last Updated: February 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014