Dietary Behavior Intervention in African Americans at Risk for Cardiovascular Disease (NCT04305431) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Dietary Behavior Intervention in African Americans at Risk for Cardiovascular Disease
United States43 participantsStarted 2021-02-25
Plain-language summary
Background:
The risk of heart disease among African Americans is still common despite a greater understanding of the disease and better approaches to managing it. Healthy cooking and eating patterns can help reduce the risk of heart disease. But things like access to grocery stores and knowledge of good nutrition can affect these healthy patterns. Researchers want to see if community-based programs can help.
Objective:
To learn about the cooking behaviors of African American adults at risk for heart disease. Also, to see if a community-based cooking intervention will affect home-cooking behaviors.
Eligibility:
African American adults 18 and older who live in Wards 7 and 8 of Washington, D.C., and have at least one self-reported risk factor for heart disease
Design:
Phase I participants will complete a survey. It asks about their medical history, lifestyle, stress level, and eating habits. They will take part in a focus group. During this, they will talk about what they eat and what foods are available to them. Participation lasts 1 day for 3 hours at Pennsylvania Avenue Baptist Church in Washington, D.C.
Phase II participants will go to shared cooking events at Pennsylvania Avenue Baptist Church. These will be held once a week for 6 weeks. They will be led by a trained chef. Participants will visit the NIH Clinical Center 3 times. Transportation will be provided if they need it. They will have physical exams and have blood drawn. They will be interviewed and complete questionnaires. A dietician will review the food they eat. An occupational therapist will assess their cooking skills. They will keep a daily cooking journal. Participation lasts 18 weeks.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* FIRST PHASE:
A sample of AA adults (n= 20) living in Wards 7 or 8 of Washington, D.C. will be recruited for this phase.
INCLUSION CRITERIA:
English-speaking
Self-identified AA adults (defined as age greater than or equal to 18)
Live in Wards 7 or 8 in Washington, D.C.
At least one self-reported risk factor for CV disease known by participant or told to participant by a clinician within the last 12 months. Specific risk factors are:
* overweight or obese (self-reported height and weight compute to BMI if needed greater than or equal to 25)
* elevated waist to hip ratio
* elevated cholesterol
* clinical hypertension or prehypertension
* prediabetes
* elevated fasting glucose level on laboratory report
* current smoker or prior (within the past 12 months) smoker.
EXCLUSION CRITERIA:
Under the age of 18
Do not live in Wards 7 or 8 in Washington, D.C.
No risk factors for CVD
Or adults not of AA descent (self-identified)
Non-English speaking
SECOND PHASE:
A sample of AA adults (n= 35) living in Wards 7 or 8 of Washington, D.C. will be recruited for this phase.
INCLUSION CRITERIA:
English-speaking
Self-identified AA adults (defined as age greater than or equal to 18)
Who live in Wards 7 or 8 in Washington, D.C.
At least one self-reported risk factor for CV disease known by participant or told to participant by a clinician within the last 12 months. Specific risk factors are:
* overweight or obese (self-reported height and weight compute to BMI if needed \>= 25…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility Measures
Timeframe: 26 weeks
2
Facilitators and Barriers
Timeframe: 26 weeks
Trial details
NCT IDNCT04305431
SponsorNational Institutes of Health Clinical Center (CC)