Dietary Approaches for Cardiovascular Health Study
Family Meals as a Strategy for the Primary Prevention of Cardiovascular Disease in Children
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cardiovascular-diseases
Started Apr 2022
Typical duration for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2021
CompletedFirst Posted
Study publicly available on registry
January 6, 2022
CompletedStudy Start
First participant enrolled
April 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2025
CompletedMarch 20, 2025
March 1, 2025
3.1 years
December 6, 2021
March 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in diet quality.
The Healthy Eating Index is a score ranging from 0-100 with higher scores indicating greater adherence to the Dietary Guidelines.
Baseline and Months 2, 6, 8 and 10
Secondary Outcomes (8)
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 fasting insulin
Baseline and Month 6
Change from baseline in fasting glucose
Baseline and Month 6
Change from baseline in lipid levels
Baseline and Month 6
- +3 more secondary outcomes
Study Arms (2)
Family Meals
EXPERIMENTALHave at least 5 dinners per week.
Standard
ACTIVE COMPARATORConsume the recommended amounts of fruits and vegetables.
Interventions
A family-based multicomponent lifestyle modification intervention with the goal to increase the frequency of family meals and meet physical activity recommendations.
A family-based multicomponent lifestyle modification intervention with the goal to increase the consumption of fruits and vegetables and and meet physical activity recommendations.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Delawarelead
- National Institutes of Health (NIH)collaborator
Study Sites (1)
University of Delaware, Energy Balance and Nutrition Laboratory
Newark, Delaware, 19713, United States
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2021
First Posted
January 6, 2022
Study Start
April 15, 2022
Primary Completion
May 31, 2025
Study Completion
May 31, 2025
Last Updated
March 20, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share