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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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in diet quality.
Secondary outcome measures
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

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
154 Previous Clinical Trials
25,121 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,786 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant maximum for this clinical trial?

"Affirmative. The clinicaltrials.gov website indicates that this medical trial is actively recruiting participants, having been first posted on April 15th 2022 and most recently revised on April 29th 2022. At present, 90 individuals are being sought from one site for the study."

Answered by AI

Is registration still available for the current iteration of this study?

"Clinicaltrials.gov reveals that this medical trial is actively searching for individuals to take part in it. It was originally posted on April 15th 2022 and most recently amended on the 29th of the same month."

Answered by AI

Am I qualified to enroll in this clinical investigation?

"The recruitment of 90 children aged 6-12 years suffering from cardiovascular diseases is underway. The required criteria for participants consists of the child having a BMI below the 95th percentile, and at least two other CVD risk factors such as smoking, high cholesterol, hypertension, sedentary lifestyle, obesity or diabetes reported by their parent/guardian."

Answered by AI

Does this clinical trial encompass participants aged under fifty?

"The eligibility requirements for this clinical trial dictate that participants must be between 6 and 12 years of age."

Answered by AI
~32 spots leftby May 2025