Study Summary
This trial will examine if eating meals as a family more often can help prevent heart disease.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: Baseline and Months 2, 6, 8 and 10
Baseline and Month 6
Change from baseline in blood pressure
Change from baseline in carotid-to-femoral pulse wave velocity (PVW)
Change from baseline in fasting glucose
Change from baseline in fasting insulin
Change from baseline in lipid levels
Change from baseline in pulse wave analysis.
Change in baseline in flow-mediated dilation (FMD)
Month 2
Change from baseline in body mass index z-scores (zBMI)
Change from baseline in diet quality.
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Standard
1 of 2
Family Meals
1 of 2
Active Control
Experimental Treatment
90 Total Participants · 2 Treatment Groups
Primary Treatment: Family Meals · No Placebo Group · N/A
Family Meals
Behavioral
Experimental Group · 1 Intervention: Family Meals · Intervention Types: BehavioralStandard
Behavioral
ActiveComparator Group · 1 Intervention: Standard · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and months 2, 6, 8 and 10
Who is running the clinical trial?
University of DelawareLead Sponsor
135 Previous Clinical Trials
36,681 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,442 Previous Clinical Trials
24,578,188 Total Patients Enrolled
Eligibility Criteria
Age 6 - 12 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a child with a BMI-for-sex and age between 6 and 12 years old.
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Conditions
Cancer Related
Treatments