Dietary Approaches for Cardiovascular Health Study

Sponsor
University of Delaware (Other)
Overall Status
Recruiting
CT.gov ID
NCT05180435
Collaborator
National Institutes of Health (NIH) (NIH)
90
1
2
25.5
3.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Family Meals
  • Behavioral: Standard
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Family Meals as a Strategy for the Primary Prevention of Cardiovascular Disease in Children
Actual Study Start Date :
Apr 15, 2022
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Family Meals

Have at least 5 dinners per week.

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.

Active Comparator: Standard

Consume the recommended amounts of fruits and vegetables.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in diet quality. [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 Outcome Measures

  1. Change from baseline in body mass index z-scores (zBMI) [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 [Baseline and Month 6]

    Both systolic and diastolic blood pressure.

  3. Change from baseline in fasting insulin [Baseline and Month 6]

    Measure of insulin in the blood after fasting.

  4. Change from baseline in fasting glucose [Baseline and Month 6]

    Measure of blood sugar (glucose) after fasting.

  5. Change from baseline in lipid levels [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. [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) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Delaware, Energy Balance and Nutrition Laboratory Newark Delaware United States 19713

Sponsors and Collaborators

  • University of Delaware
  • National Institutes of Health (NIH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Delaware
ClinicalTrials.gov Identifier:
NCT05180435
Other Study ID Numbers:
  • 1761471
First Posted:
Jan 6, 2022
Last Update Posted:
May 5, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 5, 2022