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OpenTrials
Active, Not Recruiting

NCT Number: NCT05180435

Dietary Approaches for Cardiovascular Health Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiovascular Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware, Energy Balance and Nutrition Laboratory

Newark, Delaware, 19713, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Family Meals

Behavioral

A family-based multicomponent lifestyle modification intervention with the goal to increase the frequency of family meals and meet physical activity recommendations.

Standard

Behavioral

A family-based multicomponent lifestyle modification intervention with the goal to increase the consumption of fruits and vegetables and and meet physical activity recommendations.

Primary outcomes

  1. Change from baseline in diet quality.

    Time frame: Baseline and Months 2, 6, 8 and 10

    The Healthy Eating Index is a score ranging from 0-100 with higher scores indicating greater adherence to the Dietary Guidelines.

Secondary outcomes

  1. Change from baseline in body mass index z-scores (zBMI)

    Time frame: Baseline and Months 2, 6, 8 and 10

    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.

  2. Change from baseline in blood pressure

    Time frame: Baseline and Month 6

    Both systolic and diastolic blood pressure.

  3. Change from baseline in fasting insulin

    Time frame: Baseline and Month 6

    Measure of insulin in the blood after fasting.

  4. Change from baseline in fasting glucose

    Time frame: Baseline and Month 6

    Measure of blood sugar (glucose) after fasting.

  5. Change from baseline in lipid levels

    Time frame: Baseline and Month 6

    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.

  6. Change from baseline in pulse wave analysis.

    Time frame: Baseline and Month 6

    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.

  7. Change from baseline in carotid-to-femoral pulse wave velocity (PVW)

    Time frame: Baseline and Month 6

    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.

  8. Change in baseline in flow-mediated dilation (FMD)

    Time frame: Baseline and Month 6

    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.

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2022
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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