Dairy Foods and Blood Pressure in Multi-Ethnic Children
2 other identifiers
interventional
2,115
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2007
CompletedFirst Posted
Study publicly available on registry
July 2, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFebruary 12, 2013
February 1, 2013
1.8 years
June 27, 2007
February 8, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Blood Pressure Measurements
0, 3 and 6 Months
Secondary Outcomes (3)
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
Study Arms (2)
Two Servings of Dairy Snacks
EXPERIMENTALIntervention group received two servings of dairy food per day as a snack at school for 6 months as well as nutrition education.
No Dairy Snacks
NO INTERVENTIONControl Group did not receive any snacks or education.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Willingness to participate in the study
- Signed informed consent form by the parents and/or guardians
- Assent from the child
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Debra K. Sullivan, PhD, RD, LD
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chair, Midwest Dairy Professor of Clinical Nutrition
Study Record Dates
First Submitted
June 27, 2007
First Posted
July 2, 2007
Study Start
August 1, 2007
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
February 12, 2013
Record last verified: 2013-02