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Family Meal Intervention for Cardiovascular Health

N/A
Recruiting
Research Sponsored by University of Delaware
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Parents who have a male or female child aged 6-12 years-old with a BMI-for-sex and age <95th percentile
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and months 2, 6, 8 and 10
Awards & highlights
No Placebo-Only Group

Summary

This trial will examine if eating meals as a family more often can help prevent heart disease.

Who is the study for?
This trial is for parents aged 18 or older with a child between 6-12 years old who isn't obese. The parent must have at least two CVD risk factors like smoking, high cholesterol, high blood pressure, lack of exercise, being overweight, or diabetes. They need to speak English and have internet access.
What is being tested?
The study is testing if having family meals together can help prevent heart disease (CVD). It compares the effects of standard dietary advice against the practice of sharing meals as a family on cardiovascular health.
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects are not typical in the same way as drug trials. However, participants may experience changes in weight or eating habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child is between 6-12 years old and has a healthy weight for their age and sex.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and months 2, 6, 8 and 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and months 2, 6, 8 and 10 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in diet quality.
Secondary study objectives
Change from baseline in blood pressure
Change from baseline in body mass index z-scores (zBMI)
Change from baseline in carotid-to-femoral pulse wave velocity (PVW)
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Family MealsExperimental Treatment1 Intervention
Have at least 5 dinners per week.
Group II: StandardActive Control1 Intervention
Consume the recommended amounts of fruits and vegetables.

Find a Location

Who is running the clinical trial?

University of DelawareLead Sponsor
161 Previous Clinical Trials
25,502 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,172,028 Total Patients Enrolled

Media Library

Family Meals Clinical Trial Eligibility Overview. Trial Name: NCT05180435 — N/A
Cardiovascular Disease Research Study Groups: Family Meals, Standard
Cardiovascular Disease Clinical Trial 2023: Family Meals Highlights & Side Effects. Trial Name: NCT05180435 — N/A
Family Meals 2023 Treatment Timeline for Medical Study. Trial Name: NCT05180435 — N/A
~12 spots leftby May 2025
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