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

University of Delaware1 site in 1 country42 target enrollmentApril 15, 2022

ConditionsCardiovascular Diseases

Overview

Phase: N/A
Intervention: Not specified
Conditions: Cardiovascular Diseases
Sponsor: University of Delaware
Enrollment: 42
Locations: 1
Primary Endpoint: Change from baseline in diet quality.
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 15, 2022

End Date

May 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Delaware

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Change from baseline in body mass index z-scores (zBMI)(Baseline and Months 2, 6, 8 and 10)
Change from baseline in blood pressure(Baseline and Month 6)
Change from baseline in carotid-to-femoral pulse wave velocity (PVW)(Baseline and Month 6)
Change from baseline in fasting insulin(Baseline and Month 6)
Change in baseline in flow-mediated dilation (FMD)(Baseline and Month 6)
Change from baseline in fasting glucose(Baseline and Month 6)
Change from baseline in pulse wave analysis.(Baseline and Month 6)
Change from baseline in lipid levels(Baseline and Month 6)