Dietary Approaches for Cardiovascular Health Study

Cardiovascular Diseases Clinical Trial

Official title:

Family Meals as a Strategy for the Primary Prevention of Cardiovascular Disease in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05180435
• Other study ID #: 1761471
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: February 2024
• Source: University of Delaware
• Contact: Shannon Robson, PhD, MPH, RD
• Phone: 302-831-6674
• Email: robson[@]udel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• Family Meals
A family-based multicomponent lifestyle modification intervention with the goal to increase the frequency of family meals and meet physical activity recommendations.
• Standard
A family-based multicomponent lifestyle modification intervention with the goal to increase the consumption of fruits and vegetables and and meet physical activity recommendations.

Locations

Country	Name	City	State
United States	University of Delaware, Energy Balance and Nutrition Laboratory	Newark	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
University of Delaware	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

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