Cardiovascular Diseases Clinical Trial
Official title:
Family Meals as a Strategy for the Primary Prevention of Cardiovascular Disease in Children
NCT number | NCT05180435 |
Other study ID # | 1761471 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 15, 2022 |
Est. completion date | May 31, 2025 |
The primary purpose of this study is to examine the efficacy of family meal frequency as an intervention target in addressing the primary prevention of CVD.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | May 31, 2025 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility | Inclusion Criteria: - Parents who have a male or female child aged 6-12 years-old with a BMI-for-sex and age <95th percentile - Parent age is =18 years-old - Parent reports at least 2 of the following CVD risk factors: smoking, high cholesterol, high blood pressure, physical inactivity, overweight/obesity, diabetes - Parent is able to read, speak and understand English Exclusion Criteria: - Parents who live with their child <5 days per week - Parents who do not have access to the internet and/or are unable to attend intervention sessions - Parents who report a medical condition that impacts growth or requires a specific eating plan for themselves or their child. |
Country | Name | City | State |
---|---|---|---|
United States | University of Delaware, Energy Balance and Nutrition Laboratory | Newark | Delaware |
Lead Sponsor | Collaborator |
---|---|
University of Delaware | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in diet quality. | The Healthy Eating Index is a score ranging from 0-100 with higher scores indicating greater adherence to the Dietary Guidelines. | Baseline and Months 2, 6, 8 and 10 | |
Secondary | Change from baseline in body mass index z-scores (zBMI) | Body mass index z-scores (zBMI) will be calculated using Centers for Disease Control and Prevention growth charts. Height will be measured in centimeters and weight will be measured in kilograms and used to calculate BMI as kilograms/meter squared. | Baseline and Months 2, 6, 8 and 10 | |
Secondary | Change from baseline in blood pressure | Both systolic and diastolic blood pressure. | Baseline and Month 6 | |
Secondary | Change from baseline in fasting insulin | Measure of insulin in the blood after fasting. | Baseline and Month 6 | |
Secondary | Change from baseline in fasting glucose | Measure of blood sugar (glucose) after fasting. | Baseline and Month 6 | |
Secondary | Change from baseline in lipid levels | Nuclear magnetic resonance (NMR) measures of lipoprotein (low-density lipoprotein [LDL], high-density lipoprotein [HDL], very-low density lipoprotein [VLDL]) particle number and size will be assessed. | Baseline and Month 6 | |
Secondary | Change from baseline in pulse wave analysis. | PWA will be assessed by a central aortic pressure waveform synthesized from the measured brachial artery pressure waveform via a standard blood pressure cuff inflation/deflation and blood pressure monitoring. | Baseline and Month 6 | |
Secondary | Change from baseline in carotid-to-femoral pulse wave velocity (PVW) | Carotid-to-femoral PWV will be measured by simultaneously recording electrocardiography (ECG) and a carotid or femoral pressure waveform via a standard blood pressure cuff inflation/deflation and blood pressure monitoring. The distance from the carotid measurement point to the sternal notch will be subtracted from the distance from the sternal notch to the femoral measurement point and used as propagation distance. PWV will be calculated as propagation distance/time delay. PWV is a measure of regional stiffness of the aorta. | Baseline and Month 6 | |
Secondary | Change in baseline in flow-mediated dilation (FMD) | The FMD technique will be employed by assessing the diameter and blood flow velocity of the artery located in the upper arm via ultrasonography. FMD will be used as a measure of endothelial-dependent vessel function and will be expressed as a percent change from baseline, normalized for shear rate calculated from blood flow velocity and vessel diameter data. | Baseline and Month 6 |
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