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Dairy Foods and Blood Pressure in Multi-Ethnic Children

D

Debra K. Sullivan, PhD, RD

Status

Completed

Conditions

Blood Pressure, High

Treatments

Behavioral: Two Servings of Dairy Snacks

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00495105
1R01HL080967-01A2 (U.S. NIH Grant/Contract)
8586

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,115 patients

Sex

All

Ages

8 to 12 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2,115 participants in 2 patient groups

Two Servings of Dairy Snacks
Experimental group
Description:
Intervention group received two servings of dairy food per day as a snack at school for 6 months as well as nutrition education.
Treatment:
Behavioral: Two Servings of Dairy Snacks
No Dairy Snacks
No Intervention group
Description:
Control Group did not receive any snacks or education.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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