Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00495105
Status:
COMPLETED
Last Update Posted:
2013-02-12
First Post:
2007-06-27
Brief Title:
Dairy Foods and Blood Pressure in Multi-Ethnic Children
Sponsor:
Debra K Sullivan PhD RD
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
Dairy Foods and Blood Pressure in Multi-Ethnic Children
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 kgm2 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 racialethnic 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HL080967-01A2 | NIH | None | httpsreporternihgovquickSearch1R01HL080967-01A2 |
| 8586 | None | None | None |