Cardiovascular DiseasesNCT05180435
Dietary Approaches for Cardiovascular Health Study
A study testing Family Meals and Standard in people with Cardiovascular Diseases, run by University of Delaware at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Family Meals and Standard
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2022to 31 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Delaware, Energy Balance and Nutrition Laboratory
Newark, Delaware, 19713
About this study
Official title: Family Meals as a Strategy for the Primary Prevention of Cardiovascular Disease in Children
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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Family Meals, Standard
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family MealsBehavioural
A family-based multicomponent lifestyle modification intervention with the goal to increase the frequency of family meals and meet physical activity recommendations.
StandardBehavioural
A family-based multicomponent lifestyle modification intervention with the goal to increase the consumption of fruits and vegetables and and meet physical activity recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Family Meals | Experimental | Have at least 5 dinners per week. Receives: Behavioral: Family Meals |
| Standard | Active comparator | Consume the recommended amounts of fruits and vegetables. Receives: Behavioral: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Months 2, 6, 8 and 10
Secondary outcomes (8)
Change from baseline in body mass index z-scores (zBMI)
Body mass index z-scores (zBMI) will be calculated using Centers for Disease Control and Prevention growth charts. Height will be measured in centimeters and weight will be measured in kilograms and used to calculate BMI as kilograms/meter squared.
Measured: Baseline and Months 2, 6, 8 and 10
Change from baseline in blood pressure
Both systolic and diastolic blood pressure.
Measured: Baseline and Month 6
Change from baseline in fasting insulin
Measure of insulin in the blood after fasting.
Measured: Baseline and Month 6
Change from baseline in fasting glucose
Measure of blood sugar (glucose) after fasting.
Measured: Baseline and Month 6
Change from baseline in lipid levels
Nuclear magnetic resonance (NMR) measures of lipoprotein (low-density lipoprotein [LDL], high-density lipoprotein [HDL], very-low density lipoprotein [VLDL]) particle number and size will be assessed.
Measured: Baseline and Month 6
Change from baseline in pulse wave analysis.
PWA will be assessed by a central aortic pressure waveform synthesized from the measured brachial artery pressure waveform via a standard blood pressure cuff inflation/deflation and blood pressure monitoring.
Measured: Baseline and Month 6
Change from baseline in carotid-to-femoral pulse wave velocity (PVW)
Carotid-to-femoral PWV will be measured by simultaneously recording electrocardiography (ECG) and a carotid or femoral pressure waveform via a standard blood pressure cuff inflation/deflation and blood pressure monitoring. The distance from the carotid measurement point to the sternal notch will be subtracted from the distance from the sternal notch to the femoral measurement point and used as propagation distance. PWV will be calculated as propagation distance/time delay. PWV is a measure of regional stiffness of the aorta.
Measured: Baseline and Month 6
Change in baseline in flow-mediated dilation (FMD)
The FMD technique will be employed by assessing the diameter and blood flow velocity of the artery located in the upper arm via ultrasonography. FMD will be used as a measure of endothelial-dependent vessel function and will be expressed as a percent change from baseline, normalized for shear rate calculated from blood flow velocity and vessel diameter data.
Measured: Baseline and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start15 Apr 2022
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180435
- Sponsor's protocol ID
- 1761471
- Status last verified
- Mar 2025
- First submitted
- 6 Dec 2021
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Meals as a Strategy for the Primary Prevention of Cardiovascular Disease in Children
- ClinicalTrials.gov ID
- NCT05180435
- Acronym / sponsor ID
- 1761471
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Meals | Experimental | Behavioral: Family MealsHave at least 5 dinners per week. |
| Standard | Active comparator | Behavioral: StandardConsume the recommended amounts of fruits and vegetables. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family MealsA family-based multicomponent lifestyle modification intervention with the goal to increase the frequency of family meals and meet physical activity recommendations. | Behavioural | Family Meals |
| StandardA family-based multicomponent lifestyle modification intervention with the goal to increase the consumption of fruits and vegetables and and meet physical activity recommendations. | Behavioural | Standard |
Primary outcome
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.
8 secondary outcomes
Change from baseline in body mass index z-scores (zBMI)
Time frame: Baseline and Months 2, 6, 8 and 10
Change from baseline in blood pressure
Time frame: Baseline and Month 6
Change from baseline in fasting insulin
Time frame: Baseline and Month 6
Change from baseline in fasting glucose
Time frame: Baseline and Month 6
Change from baseline in lipid levels
Time frame: Baseline and Month 6
Change from baseline in pulse wave analysis.
Time frame: Baseline and Month 6
Change from baseline in carotid-to-femoral pulse wave velocity (PVW)
Time frame: Baseline and Month 6
Change in baseline in flow-mediated dilation (FMD)
Time frame: Baseline and Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Meals and Standard in people with Cardiovascular Diseases, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in diet quality. (time frame: Baseline and Months 2, 6, 8 and 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.